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UNIVERSITY OF TENNESSEE, KNOXVILLE DEPARTMENT OF NUTRITION

Developing Self-Regulation in Individuals with Type 2 Diabetes

Lusi M. Martin MS-MPH Graduate Student

October 31, 2008

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Table of Contents

Abstract………………………………………………………………………………………… 4

Background and Significance………………………………………………………………….. 5

Economic Toll of Diabetes…………………………………………………………….. 6

Diabetes Self-Management Education (DSME)……………………………………….. 7

Self-Monitoring Blood Glucose (SMBG)……………………………………………… 7

The importance of self-regulation in diabetes management………………………….. 10

Relationship between self-efficacy and diabetes management………………………. . 12

Summary……………………………………………………………………………….. 13

Specific Aims…………………………………………………………………………………… 15

Experimental Design and Methods……………………………………………………………. 16

Overview of Study design…………………………………………………………….. 16

Participants……………………………………………………………………………. 17

Recruitment…………………………………………………………………………… 18

Procedures…………………………………………………………………………………….. 19

Randomization………………………………………………………………………… 20

Intervention…………………………………………………………………………………… 20

Treatment Structure…………………………………………………………………… 20

Components of behavioral treatment common to conditions…………………………. 21

Differences between conditions……………………………………………………….. 24

Handling Phone Contacts………………………………………………………………………. 25

Handling Unreturned Diaries………………………………………………………………….. 26

Minimizing Attrition…………………………………………………………………………… 26

Measures………………………………………………………………………………………. 26

Statistical Analysis…………………………………………………………………………….. 29

References…………………………………………………………………………………….. 30

Appendices

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List of Figures and Tables

Table 1: Proposed skills addressed in diabetes management intervention…………………… 13

Table 2: Study Design…………………………………………………………………………. 16

Table 3: Measurement Plan……………………………………………………………………. 28

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Abstract

As our nation continues to battle overweight and obesity, the prevalence of diabetes will

precipitously increase, placing additional financial burden on our country1. Therefore, finding

ways to manage this chronic disease is essential. While self-monitoring of blood glucose

(SMBG) has been shown to be effective in improving glycemic control in individuals with type 1

diabetes2, the importance of encouraging individuals with type 2 diabetes to engage in SMBG for

better blood glucose (BG) is still unclear3. SMBG is believed to be key in the self-management

of diabetes, as it can provide feedback on dietary and activity behaviors that are believed to

impact on BG. The use of SMBG to adjust other behaviors that impact on BG is a self-

regulatory approach to diabetes management. Self-regulation of BG is theorized to impact on

self-efficacy in the management of diabetes. Through greater self-efficacy, greater compliance to

diabetes self-management behaviors is achieved4. Currently, no trial has examined the use of a

self-regulation approach using current dietary and physical activity recommendations for

individuals with type 2 diabetes who are not on insulin. Therefore, the purpose of this

investigation is to compare a self-regulation intervention (SR), in which participants will self-

monitor their BG and adjust dietary intake and physical activity through the use of current

dietary and physical activity guidelines to help regulate their BG, to an education and self-

monitoring only intervention (SM), in individuals with type 2 diabetes who are not on insulin.

We anticipate that the SR condition will have greater frequency of SMBG, more improved

glycemic control, and higher self-efficacy of diabetes self care activities than the SM condition at

3 months. Additionally, dietary intake, physical activity, quality of life and body weight

measurements will be taken at 0 and 3 months for comparisons between the two treatment

groups.

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Background and Significance

The prevalence of overweight and obesity in the United States continues to gain much

attention due to its effect on many health conditions. One chronic health condition closely

correlated to weight status is type 2 diabetes5, which is the most prevalent form of diabetes in the

United States6. Type 2 diabetes often begins with insulin resistance, which is theorized to be

related to weight status1,2,7,8,9

.With insulin resistance, cells do not use insulin properly, and

glucose cannot be transported into cells appropriately. Insulin resistance promotes

hyperinsulinemia, in which higher levels of insulin are produced to aid with lowering blood

glucose levels. As the need for insulin increases, the pancreas can become overworked and not

meet the demands required to clear blood glucose appropriately, and eventually reach a stage in

which it is not able to produce insulin, resulting in higher than normal blood glucose levels1.

In the past, type 2 diabetes was called non-insulin-dependent diabetes mellitus or adult-

onset diabetes. This condition was previously given this name because most cases of diabetes

diagnosed during childhood were insulin-dependent, in which the pancreas no longer produced

insulin. Contrary to this, in adulthood when diabetes develops, most often the pancreas is still

producing insulin and therefore treatment of the disease in its early stages does not require

insulin, and therefore is non-insulin-dependent. Due to this differential in insulin supply, the

names insulin-dependent and child-hood-onset were used for the form of diabetes previously

commonly diagnosed during childhood, while the names non-insulin-dependent and adult-onset

were used for the form of diabetes commonly diagnosed during adulthood. However recent

clinically based reports and regional studies propose that children are now developing a form of

diabetes that is due to insulin resistance, rather than a lack of insulin production, most likely as a

consequence of the increase in the prevalence of overweight/obesity currently seen in the

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pediatric population10

. Additionally, as non-insulin-dependent diabetes progresses, insulin may

be required for treatment1. Thus, the two forms of diabetes are now called type 1 and type 2, and

reflect more the pathogenesis of the form of diabetes an individual has, rather than age of onset

or treatment required.

The scientific evidence supporting overweight/obesity to the development of type 2

diabetes has led the World Health Organization (WHO) to predict a precipitous increase (39%)

in the global rate of type 2 diabetes from 2000-20305. However, other reports have found that

this may be an underestimation of the global rate of diabetes prevalence11

. Other factors that

may be influencing the increased prevalence of type 2 diabetes, include changes in diagnostic

measures, improvement and enhanced detection, decrease (of) mortality leading to the elderly

population living longer, and the rise in minority populations, such as American Indians,

African-Americans, and Hispanic/Latino Americans in the United States, in whom the incidence

and prevalence of diabetes continues to increase1.

Economic Toll of Diabetes in the United States

According to the American Diabetes Association’s “Economic Cost of Diabetes in the

U.S. in 2007,” approximately 17.5 million people in the U.S. have been diagnosed with

diabetes12

. In comparison to the economic cost estimate from 2002, the number of people

diagnosed with diabetes has grown by about 1 million people per year. For 2007, total national

cost related to diabetes in the U.S. was approximately $174 billion, which is a $21 billion

increase since the 2002 cost estimate of diabetes12

. The rise in the cost of diabetes in 2007

demonstrates a rise in diabetes incidence, increased medical costs, and improvements in the

methods and data sources developed to estimate diabetes expenditure12

. As costs associated

with diabetes have increased dramatically, improving patient self-management of diabetes

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(especially poorly managed and uncontrolled diabetes) may assist in alleviating some of the

health care costs associated with this chronic disease.

Diabetes Self-Management Education (DSME)

Over the years, treatment of diabetes has evolved from didactic interventions that focused on

helping patients gain knowledge and skills about diabetes to more self-management-focused

interventions13, 14

. Diabetes Self-Management Education (DSME) is the “ongoing process of

facilitating the knowledge, skill, and ability necessary for diabetes self-care (S6)”6. Self-care

activities in which individuals with diabetes are encouraged to perform during a self-

management education session involve engaging in a range of activities such as monitoring BG,

eating a proper diet, exercising, and foot care. In fact, it is believed that the self-management

approach to diabetes treatment is central to preventing and/or managing the progression of the

disease6, 16

. Self-management focused programs address not only knowledge and skills but also

address emotional, motivational and cognitive barriers to effective diabetes therapy14

. National

standards require individuals diagnosed with diabetes to receive diabetes self-management

education (DSME) at time of diagnosis and as needed thereafter6.

Evidence to support this shift from a didactic to a self-management approach can be found in

the improved glycemic control reported in a trial directly comparing these two types of

interventions in participants with type 2 diabetes14

. In a randomized trial, Kulzer et al.14

examined the efficacy of three interventions on glycemic control in participants with type 2

diabetes. The first intervention, treatment A, was a didactic focused training program, in which

the focus was on acquisition on attaining the skills and information on treating diabetes. The

other two interventions, treatment B and C, were self-management-focused programs, in which

lifestyle modifications (diet and physical activity) were encouraged, however no specific goals

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were provided or instruction on modifying diet and/or physical activity manage BG. The primary

difference between treatment B and C was in the format of the delivery of the intervention.

Treatment B was delivered via a group format, while treatment C was delivered in both a group

and individual format. Results revealed that there was significant improvement in HbA1c in the

self-management focused programs, with both treatment B and C showing better glycemic

control at 3 months than treatment A, with treatment B’s, but not treatment C’s, improved

control sustained at the final measurement at 15 month. In summary, Kulzer et al.14

concluded

that their study supported the efficacy of self-management in diabetes prevention/management.

However, despite the favorable findings on the efficacy of self-management in diabetes care; the

research design may explain why the findings favored the self-management approach. Out of the

3 intervention groups, treatment B and C received 12 lessons of 90 minutes each, while treatment

A only received 4 lessons of 90 minutes each, thus treatment B and C received a more intensive

intervention than treatment A. Surprisingly, one important component of self-management of

diabetes that was not a focus in any of the programs was SMBG.

Self-Monitoring Blood Glucose (SMBG)

SMBG is the sole act of individuals with diabetes testing their blood sugar frequently to

assist with achieving glycemic goals15

. Initially, SMBG was used in the past primarily with

individuals with type 1 diabetes, while weight loss was the initial treatment for individuals with

type 2 diabetes2. As a result, Wing et al

7, initially conducted a randomized controlled trial

(RCT) testing the effect of adding SMBG to a behavioral weight loss program with patients with

type 2 diabetes. Participants were either randomized to a standard behavioral weight control

program or to a program focused on weight and blood glucose monitoring. Their results found

both groups had significant effects on weight loss and glycemic control. However, SMBG had

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no effects on treatment regimen. Wing et al7 suggest the unfavorable results may have been that

subjects learned to monitor their BG, but did not learn to adjust behaviors to improve BG

outcomes.

To address this shortcoming, Wing et al2 conducted a study focusing on teaching individuals

with type 2 diabetes to use information collected from SMBG to adjust eating and exercise

behaviors for more favorable BG outcomes. The study was intended to establish whether

extensive training in self-regulation of BG would improve outcomes compared to a self-

monitoring only. Twenty participants were randomly assigned to either the Self-monitoring or

Self-regulation program. Both groups received a standard behavioral weight control program

consisting of 13 treatment meetings, spaced over 16 weeks. Meetings were held weekly for 10

weeks, and every two weeks for the following 6 weeks. Follow up meetings took place every 2

weeks for the next 3 months, and monthly thereafter for the following 3 months. One-year

follow up meeting was held at week 68. Participants were given calorie goals depending on

body weight, exercise in the form of walking was encouraged, and the exercise goal was

gradually increased to a goal of a two-mile walk five times a week. Subjects were given Accu-

Check meters and SMBG supplies at no cost. They were also asked to monitor BG 12 times per

week, with a fasting, preprandial, and postprandial reading taken Monday, Tuesday, Thursday

and Saturday. Subjects were taught about the caloric value of protein, fat, and carbohydrate and

training in portions size estimations. In addition, other training focused on behavioral strategies

for controlling cues for eating, dealing with social situations involving foods, changing

cognitions about food and dieting, motivation, self-reinforcement, and problem solving for

challenging situations. The major difference between the Self-regulation and Self-monitoring

conditions was that the Self-regulation condition was given extensive training gradually over

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time on how to use the information from their SMBG to adjust their behaviors to obtain BG

control. Their study revealed that participants in the Self-regulation program self-monitored

their BG accurately and reportedly made behavior modifications, yet these adjustments did not

change BG consistently. However, no data was collected on the types of changes made by

participants when BG readings were not within target goals. The dietary behaviors that

participants were encouraged to engage in to improve their BG control (increasing fiber intake,

reducing caloric intake by 50 kcals with no emphasis on carbohydrate intake, or eating no simple

sugars) are now known to not influence blood glucose as directly as overall carbohydrate intake.

In addition, the importance of weight loss in managing diabetes was also not emphasized in the

program, which current recommendations emphasize the importance of weight loss in improving

BG levels. The one-year follow up showed no significant difference in HbA1c levels from

baseline in either of the two treatments. As the dietary behaviors that participants were

encouraged to engage in did not influence BG control, it is not surprising that this trial did not

see difference in BG control between the two conditions. Therefore, the purpose of this study

will be to emphasize current recommendation, reinforce behaviors that are positively influencing

blood glucose, and guide participants toward maintaining in range BG levels.

The importance of self-regulation in diabetes management

While Wing and colleagues2 were not able to improve BG control using a self-regulation

approach, self-regulation is still hypothesized to be key in the management of diabetes15

.

According to Purdie et al9, self-regulation involves autonomy, self-efficacy, self-control, self-

direction and self-discipline which provide the ability to do the things needed to prevent

unhealthy consequences or to restore oneself to health when damage has occurred. Self-

regulation requires setting a specific level of a measurable outcome, and then adjusting factors

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that influence that outcome appropriately. In type 2 diabetes, BG levels can be set as a

measurable outcome, and then factors that relate to blood glucose levels, such as diet, physical

activity, medication, etc. can be adjusted appropriately to regulate blood glucose levels. Thus, it

is believed that SMBG, a standard component of diabetes treatment, can be used to improve self-

regulation of eating and activity behaviors, thereby improving the management of diabetes.

SMBG can assist both the diabetes patient and interventionist in drawing conclusion from the

recorded BG measurements to determine the adjustments necessary to maintain glucose

controls16

. In addition, SMBG gives patients both positive and corrective feedback that is

needed to promote the lifestyle change necessary for healthy BG outcomes.

While SMBG is believed to be an important component of successful diabetes

management, a systematic review of the effects of SMBG on BG revealed that the efficacious of

SMBG in improving BG in individuals with type 2 diabetes is still unclear3. McAndrew and

colleagues3 propose that studies investigating the effects of SMBG on glycemic control have

commonly failed to implement many of the components of behavioral monitoring that self-

regulation theory suggest would be imperative for successful self-management of type 2

diabetes. Indeed, there is a paucity of RCTs examining the effect of self-monitoring of dietary

intake, physical activity, and BG on glycemic control in individuals with type 2 diabetes.

Most RCTs of SMBG have focused on intervening on the sole act of SMBG. For example,

six studies18,19,20,21,22

compared a SMBG intervention, in which participants were educated on

how to self-monitor their BG and were encouraged by health care providers to bring in

monitoring records to sessions, to a control condition in which SMBG was not emphasized and

standard care was provided. Length of the intervention varied amongst the trials. In these

investigations, other behaviors that might influence BG levels, such as dietary intake or physical

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activity, were not monitored by participants. Of these investigations, 4 provided a frequency

prescription for SMBG 20,21,22,23

, while two investigations did not provide a frequency

prescription for SMBG18, 19

. In five of the six studies, the intervention that focused on SMBG

showed greater improvements in glycemic control as compared to the control condition 18,

19,20,22,23. In the final study, both groups, the SMBG and the control group, significantly

improved glycemic control, with no differences between the two conditions21

.

A few RCTs of SMBG have included interventions in which SMBG has also been combined

with some self-monitoring of dietary intake16, 24, 25

and compared this to a standard care

intervention. In these interventions, the frequency of SMBG was prescribed, with self-

monitoring occurring on 2 days per week. For recording dietary intake, one trial focused on

carbohydrate counting, with the frequency of recording dietary intake not defined25

, while the

other trial did not describe how dietary intake was self-monitored16, 24

. In both trials, participants

in the SMBG condition were seen by a health care professional every 4 weeks to review self-

monitoring records. Health care professionals provided guidance at these sessions on adjustments

to make to improve gylcemic control. Results of these trials showed that the participants who

received the SMBG interventions had greater improvements in glycemic control as compared to

those participants receiving standard care.

Relationship between self-efficacy and diabetes management

In addition to SMBG, individuals with diabetes have to engage in a number of other daily

activities in order to be within a healthy BG range. These activities involve monitoring food

intake, being physically active, adhering to medication regimens, and managing stress15

. With

proper diet and self-care activities, individuals with diabetes can improve glycemic control and

the need for oral medications or insulin can be reduced26

. This increase in glycemic control

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through appropriate use of self-care activities can increase confidence in one’s ability to manage

diabetes. Many researchers define this concept as self-efficacy4, 27

. Self-efficacy involves one’s

judgment of ability to perform and produce a given attainment28

. The importance of self-

efficacy in the management of diabetes is due to outcomes that indicate that higher self-efficacy

is related to better adherence to diabetes self-management activities4. For example, Senecal et

al4 examined constructs from social cognitive and self-determination theory in relation to dietary

self-care and life satisfaction among 638 participants with diabetes. Their results found a strong

link between self-efficacy and self-reported adherence to self-care activities. Thus, patients’

perceived self-efficacy in self-managing diabetes may be an important mediator in interventions

designed to improve adherence to self-management activities in diabetes.

Summary

Thus, previous research suggests that improving SMBG through combining awareness of

the relationship between blood glucose, dietary intake, and physical activity, should increase

self-regulatory capabilities for glycemic control. This increase in self-regulatory capabilities

should also increase self-efficacy in diabetes self-management, leading to improved adherence to

dietary and physical activity recommendations, improving longer-term glycemic control.

McAndrew et al.3 propose that in order for SMBG to be efficacious, interventions should address

patient’s skills in:

1. Taking a blood glucose reading.

2. Interpreting the reading as a target for action.

3. Perceiving linkages between specific behaviors (diet & exercise) and the reading

(which ones contribute to low BG and which ones contribute to high BG)

4. Implementing action plans in response to SMBG.

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5. Giving less weight to subject symptoms that are the basis for common sense

decisions that one is sick or well, as these cues are invalid guides for the regulation

of BG levels.

6. Incorporating the behavioral system into the patients’ ongoing daily behavioral

patterns.

7. Viewing difficulties in achieving control as issues of adjusting the behavioral

treatment, not deficits in personal motivation or competence for self-management.

Table 1: Proposed skills addressed in diabetes management intervention3

While a self-regulation approach is believed to be able to improve glycemic control in

individuals with type 2 diabetes, no trial at this time has investigated the effects of participants

regularly self-monitoring their carbohydrate intake, physical activity, and BG; comparing eating

and activity behaviors to BG control; receiving timely support in developing action plans for

changing eating and activity behaviors to improve BG control; implementing action plans, using

current recommendations to adjust these behaviors appropriately on BG control, diabetes self-

efficacy, and overall diabetes self-management (i.e., following a dietary and activity plan and

regularly monitoring BG). Thus, the current study will investigate whether a Self-regulation

intervention (SR) focused on SMBG (as a self-management tool) will improve glycemic control,

diabetes self-efficacy, and diabetes self-management in overweight participants with type 2

diabetes who are not on insulin. The current study will utilize the 7 skills proposed by

McAndrew et al3 to address to patients in a self-regulation intervention to see whether these

skills are efficacious in the self-management of diabetes. We hypothesize that adults with type 2

diabetes receiving a SR program will improve glycemic control, diabetes self-efficacy, and

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diabetes self-care activities (increase SMBG, follow a dietary and activity plan that more closely

meets current recommendations) and quality of life from 0 to 3 months more so than adults’ with

type 2 diabetes receiving a Self Monitoring (SM) program.

SPECIFIC AIMS

1. To investigate the effect of a self-regulation intervention on blood glucose:

This aim is concerned with the ability of self-regulation to improve blood glucose levels in

patients with type 2 diabetes. It is hypothesized that participants randomized to the SR

intervention that emphasizes the importance of recording food intake, physical activity, and

blood glucose and examining the relationships between these behaviors will have a greater

reduction on fasting blood glucose levels as compared to a SM intervention from 0 to 3 months.

2. To investigate whether a Self-Regulation program improves self-efficacy in performing

diabetes self-care activities.

This aim is concerned at what capacity self-regulation has on improving self-efficacy in

performing diabetes self-care activities. It is hypothesized that participants in SR will report

greater self-efficacy in carrying out diabetes self-care activities as compared to SM from 0 to 3

months.

3. To test the effectiveness of a self-regulation program on adherence to diabetes self

management care activities.

This aim is concerned with the ability of self-regulation to improve adherence to diabetes self

management activities. It is hypothesized that participants randomized to the SR will have

greater increased adherence to recommendations regarding monitoring of BG, carbohydrate

intake, and physical activity as compared to a SM intervention from 0 to 3 months.

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Additional comparisons of the two treatment conditions will be made on the following

measures: dietary intake, physical activity, quality of life and body weight at 0 and 3 months.

EXPERIMENTAL DESIGN AND METHODS

Overview of Study Design

This study is a randomized controlled trial of a 3-month self-regulation intervention program

designed to investigate the specific aims of the study. This study will use a 2 x 2 mixed design,

using treatment conditions (Self-regulation vs. Self-monitoring) as the between-subject factor,

and time (0 and 3 months) as the within-subject factor. Participants will be randomly assigned to

1 of 2 groups, either a Self-regulation (SM) group or a Self-monitoring (SM) group. The

dependent variables for the specific aims are blood glucose control, self-efficacy, and self-

management at baseline and at 3 months. Secondary outcomes will examine group differences

in dietary intake, physical activity, quality of life and body weight at baseline and at 3 months.

Table 2: Study design

Time (weeks)

Group 0

Baseline

1 2 3 4 5 6 7 8 9 10 11 12

Post-treatment

Self-Regulation 1. BG 2. Self efficacy 3. Dietary intake 4. Self-management

activities 5. Physical activity 6. Quality of life 7. Weight

Behavioral intervention

1. BG 2. Self-efficacy 3. Dietary intake 4. Self-management

activities 5. Physical activity 6. Quality of life 7. Weight

Self- Monitoring 1. BG 2. Self efficacy 3. Dietary intake 4. Self-management

activities 5. Physical activity 6. Quality of life 7. Weight

Behavioral intervention

1. BG 2. Self-efficacy 3. Dietary intake 4. Self-management

activities 5. Physical activity 6. Quality of life 7. Weight

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Participants

Participants will be a total of 20 men and women who agree to be randomized to either of the

2 intervention groups (Self-Regulation or Self Monitoring). Participants will be eligible based

on the following criteria:

1) Referred to the study by a physician at Cherokee Health Systems

2) Have been diagnosed with Type 2 diabetes for a minimum of 1 year

3) Fasting BG of ≥ 126mg/dl

4) Own a glucometer

5) Between the age of 21 and 65 years. Older adults may have more medical co-

morbidities and may require greater medical supervision29

6) Considered overweight or obese by the body mass index (BMI). BMI between 27 and

45 kg/m2 29

7) Not treated with insulin.

8) Are taking medicine to prevent hypoglycemia: Refer to diabetes medication list in

Appendices Ai-Aii

9) Willing to increase physical activity to 150mins/week in 3 months.

10) Able to read and understand English.

Participants will be excluded if they:

1) Report a heart condition, chest pain during periods of activity or rest or loss of

consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) 30

(See

Appendix B) Individuals self-reporting joint problems, prescription medication usage

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related to heart conditions, or other medical conditions that could limit exercise will

be required to obtain written physician consent to participate.

2) Report being unable to walk for 2 blocks (1/4 mile) without stopping.

3) Report major psychiatric diseases.

4) Are currently participating in a weight loss program, other dietary or physical activity

interventions, or diabetes self-management programs.

5) Taking any weight loss medication.

6) Pregnant, expecting to be pregnant and/or lactating.

7) Have no working phone.

8) Are unwilling to participate in phone calls that are a part of the condition that in

which they have been randomized.

Recruitment

Participants will be referred by their physician at one of the Cherokee Health Systems

locations (Seymour, Good Sam, Lenoir City, or Maynardville) to participate in a diabetes

intervention program. Flyers will be given to physicians at these Cherokee Health Systems

locations to post in their offices and to pass out to potentially eligible participants as a way to

disseminate information and contact information about the study to potential participants.

Potential participants will use the contact information provided on the flyers to call the Healthy

Eating and Activity Laboratory at the University of Tennessee to be phone screened for

eligibility (Appendix B). Participants who are eligible will be mailed a packet that will include

informed consent, MD consent and questionnaires (demographics, summary of diabetes self-care

activities, quality of life, general health history, exercise habits, self-efficacy and food diary

[Appendix C-H]. Instructions on how to complete the questionnaires will be provided on the

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phone verbally and instructions will also be included in the packet (Appendix K). Participants

will be given a week to complete questionnaires and a baseline assessment will be scheduled at

the Cherokee Health Systems location in which they heard about the trial. Informed consent and

questionnaires will be collected from participants at this meeting.

Procedures

At baseline assessment, informed and MD consent will be obtained from participants.

Following this, blood glucose will be measured using the One Touch Ultra Mini Blood Glucose

Monitoring System. In addition, height and weight will also be measured to determine BMI.

Participants will turn in the packet of questionnaires. All of the questionnaires and the 3 day

food record will be reviewed for completeness.

When the baseline assessment is completed, participants will be informed of their

treatment assignment (Self-Regulation vs. Self- Monitoring). Next, participants will be provided

with the Blood Sugar Monitoring Owner’s Manual34

used by Moreland19

, to enhance participant

knowledge and address areas proposed by McAndrew et al3. Participants will also be provided

with an individualized eating plan (Appendix I) and a physical activity goal (Appendix J) that

should produce 1-2 pounds of weight loss per week. Participants will be given 12 weeks of

diaries, in which they will record their eating habits, physical activity, and blood glucose levels.

Participants will be instructed on how and when to record the types and amounts of foods and

drinks they are consuming, their physical activity, and their blood glucose in the diary.

Participants will be instructed to return their diaries every week by mail, and will be provided

with 12 self-addressed envelopes (Appendix K). Participants will also be provided with a target

postprandial blood glucose goal (<180mg/dl), as well as basic nutrition education on the diabetic

exchange system, which provide participants with information that will be helpful for meeting all

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dietary goals. The baseline assessment along with delivery of intervention should take about 1.5

hours. Thus for both conditions, one face-to-face meeting will occur.

Following the 12 weeks of the intervention, participants will be mailed the same packet

of measures (without the demographic and health history questionnaires) to complete as they did

at baseline. An assessment meeting will be scheduled for the final collection of questionnaires,

weight, and fasting blood glucose at the initial location of the first assessment.

Randomization

Participants who meet all eligibility criteria, sign consent forms, and complete baseline

assessment procedures will be randomized to one of the 2 treatment conditions (Self Regulation

vs. Self-Monitoring). A random number table will be utilized to conduct randomization.

Interventions

Treatment Structure

The study will be over a period of 3 months and interventions for both groups will be delivered

in 3 phases.

Phase 1: Phase 1 is the first month of intervention. Weekly phone contact will be provided to

participants in both SR and SM condition.

Phase 2: Phase 2 is the second month of intervention. This phase will have 2 phone contacts

provided to participants in both groups. A newsletter will also be distributed to all participants in

phase two.

Phase 3: Finally, phase 3 is the third month of intervention. This phase will have one phone

contact with participants in both groups. A newsletter will also be distributed to all participants

in the final phase of the program.

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Components of Behavioral Treatment Common to Both Self-Regulation and Self-Monitoring

Conditions:

1. Education on SMBG: Both groups will receive an initial session regarding self-monitoring of

blood glucose, using the Blood Sugar Monitoring Owner’s Manual (BGMOM) 33

. The BGMOM

is an 18 page manual developed as a cost and time effective strategy to address barriers to BG

monitoring. In the efforts to cover a wide range of readers, the manual was created to

accommodate a middle school reading level. The manual was developed targeting patients with

type 1 or type 2 diabetes receiving various therapies, and provides useful information about BG

monitoring. Of additional importance, the manual also attempts to guide patients through their

emotional concerns about diabetes and BG monitoring. It emphasizes the importance of BG

monitoring as a way to check but not a test, and that the results from the “check” is not good or

bad, but in range or out of range33

. This manual has been used in previous trials19

. Both groups

will be instructed to monitor their BG at least once a day, alternating meals (i.e. Monday, self-

monitor BG at breakfast, Tuesday, self-monitor BG at lunch, Wednesday, self-monitor BG at

dinner etc). Emphasis will be to measure postprandial blood glucose. A good postprandial

range would be <180mg/dl.6 Participants will also be educated on the good range for pre-

prandial blood glucose 70-130mg/dl in the event they decide to take measurements before

eating.6

2. Weight loss goals: Current recommendations based on the clinical trial data from the Finnish

Diabetes Prevention study34

and the Diabetes Prevention Program (DPP)

35 in the U.S

demonstrated the importance of weight loss in the prevention and management of type 2

diabetes. Therefore, dietary and physical activity lifestyle changes characteristics (reducing total

caloric and fat intake as well as increasing physical activity) will be encouraged and emphasized

in this study based on the current recommendations from the American Diabetes Associations15

.

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3. Dietary goals: Both conditions will be instructed to consume a standard calorie and fat

restricted diet as recommended by the American Diabetes Association15

daily calorie goals will

be based on participants’ current weight taken at baseline. Those participants who are no more

than 200 lbs at entry will be prescribed a 1200 kcals/day, and weight greater than 200 lbs upon

entry will be prescribed 1500 kcal/day. In addition, participants will be given a target of no more

than 30% calories from fat (Appendix I) 15

In addition to calorie and fat goals to aid with weight loss, dietary recommendations for

individuals with type 2 diabetes includes an overall carbohydrate (CHO) goal, with the CHO

spread fairly evenly out in meals and snacks consumed15

, as the quantity of CHO is the primary

determinant of postprandial glucose response.15

The Recommended Daily Allowance (RDA) of

130g/day is an average minimum requirement set based on the requirement for brain function15

.

CHO recommendations for the current study is based on a calorie goal set based on weight as

discussed earlier. Fifty percent of total calories will be from CHO 1, an acceptable range based

on recommendations that 45-65% of total calories come from carbohydrates15

(Franz, 2003).

CHO will be distributed throughout the day (Appendix I). The CHO distribution of the current

study is above the average minimum RDA which will allow for alterations (increase or decrease)

as needed to meet glucose goals for each participant.

4. Physical Activity Goals: Evidence supports the importance of physical activity not only in

the prevention of type 2 diabetes, but also in controlling complications related to diabetes6. Both

moderate-intense and vigorous physical activity can improve insulin sensitivity, independent of

weight loss, and reduce risk for developing type 2 diabetes6. Both conditions will be instructed

to gradually increase their physical activity goal until they are active 150min/week. Initially,

participants will be encouraged to be active for 10 minutes per day, 5 times per week. They will

SMBG 23

then be instructed to increase their physical activity to 5 minutes a day each week until they have

reached the intervention goal. Participants will slowly work up to the physical activity goal in a

3 month time period. Participants will also receive education on the FITT (i.e., frequency,

intensity, time and type of activity) principle, as well as safety issues related to physical activity

(i.e., hydration, proper attire, when to stop).

To minimize barriers for physical activity, participants will be encouraged to brisk walk

and will be allowed to accumulate amount of time being physically active by engaging in

multiple short bouts (e.g., at least 10 minutes in length). Engaging in multiple bouts of physical

activity has been shown to enhance physical activity participation during the initial months of

treatment in overweight women36

. Other lifestyle activities (e.g., taking the stairs rather than the

elevator, parking their vehicle further and walking to work/grocery store etc.) will be

encouraged.

5. Self-monitoring: Both conditions will receive 3 months of self-monitoring diaries, in which

they will be instructed to record their daily dietary intake, physical activity, weight, and blood

glucose readings. To enhance adherence to self-monitoring, calorie king books will be provided

to help accurately monitor weight, calories, fat and carbohydrates from food. All participants will

be given pre-stamped envelopes for returning diaries. Self-monitoring is a key behavioral

strategy for participants to become aware of the eating and activity behaviors. Therefore, both

conditions will be strongly encouraged to self-monitor their eating and activity behaviors daily.

During the phone calls reinforcement for self-monitoring will occur and problem-solving will

take place to address issues and challenges of self-monitoring. After each phone contact, a time

and date will be set for subsequent phone calls as needed.

SMBG 24

6. Newsletter: At weeks 6 and 10, all participants will receive a newsletter. The newsletter will

include topics related to diabetes such as the importance of weight loss, BG range, some recipes

etc. The newsletter will serve as an information medium, keeping participants aware of their

participation in the project, as well as other important aspects of diabetes care.

Difference between Self-Regulation and Self-Monitoring Conditions:

Self-Regulation (SR) Condition:

Diaries turned in from the SR condition will be reviewed extensively and participants will be

provided with feedback regarding their dietary intake, physical activity, and weight change and

how these factors are related to the reported blood glucose readings in the diary. Phone contacts

during phase 1 will involve providing intensive intervention linking blood glucose results to

other components in their diary (CHO intake, overall caloric intake, physical activity, weight

change). If diaries are not mailed in by participants in the SR condition, but participant have

been self-monitoring, the diary, as described by the participant, will be reviewed over the phone

and feedback will still be given over the phone If BG readings are within acceptable range,

participants in the SR condition will be verbally reinforced for their behaviors and encouraged to

continue their self-monitoring along with their healthy eating and physical activity habits.

However, if three out of range BG measures are observed in the week from the diary, then an

action plan will be developed with the participant to bring BG levels within acceptable ranges.

The changes that will be encouraged will be to:

1. Reduce CHO to reach dietary goals.

a. This may include focusing on portion control and appropriate food selection.

2. Recommend consistent meals and snacks, especially with a focus on consistent CHO

distribution in meals and snacks.

SMBG 25

3. Decrease overall calorie and fat gram intake to aid in weight loss.

4. Increase current physical activity levels.

Self-Monitoring (SM) Condition:

Diaries returned from self-monitoring condition will be reviewed only for completeness of

self-monitoring of targeted behaviors. Topics discussed during phone contacts will include

reinforcement of self-monitoring, or problem-solving to address challenges of self-monitoring.

Additionally, to control for contact length of the phone calls participants in the SM group will

receive a general diabetes education tip (See Appendix L).

The primary difference between the two conditions is that participants in the Self-Regulation

condition will be provided additional support that will specifically enhance their development of

diabetes self-regulatory skills. The SM condition will receive no feedback about how to self-

regulate using the information from the weekly diaries (BG, weight, total calories, CHO intake,

and physical activity). Please see Appendix M for Counselor’s Guide in delivering intervention

to participants in both conditions.

Handling Phone Contacts

Phone calls will be scheduled with the participant as to what fits with their schedule. If a

participant does not answer the first attempted phone call, the research team will leave a message

describing the reasoning for the call and for the participant to call back. If participant answers

and says that it is not a good time to discuss the diary, another phone call will be scheduled.

Two attempts will be made to discuss diary and offer verbal feedback to participants, thereafter,

feedback will be mailed to participants with the address provided

SMBG 26

Handling Unreturned Diaries

In the event that a diary is not received from a participant, the researcher will promptly

call participants to discuss any issues the participant is experiencing that is appropriate for the

treatment condition they are randomized. An expected date to receive the missing diary/diaries

will be scheduled. Once diary/diaries are received, written and/or verbal feedback will be

provided promptly as well as needed reinforcement.

Minimizing Attrition

For data collection appointments, participants will be sent reminders about the upcoming

assessments, scheduled by phone, and called the day before each data collection visits. Missed

visits will be rescheduled until assessment is complete. We anticipate 100% of participants to

complete the 3 month assessment.

Measures

1. Basic demographic information (i.e. gender, age, education level) and health history will be

collected from participants at the initial assessment.

2. Weight, Height, and BMI: Participant weight will be assessed by use of a scale, and height

will be assessed using a stadiometer. Height will be measured only at the first assessment,

and weight will be measured at weeks 0 and 12 BMI will be calculated according to the

following formula: BMI=weight (lbs) x 704.5 / height (in2)38

.

3. Blood Glucose: Participants fasting BG will be taken at weeks 0 and 3 months. For the final

assessment, a targeted fasting blood glucose of < 126 mg/dl will be associated with

improvement in BG outcome from baseline.6 Assessments will be scheduled closely to

morning hours to allow participants to fast overnight in order to collect a more accurate

fasting BG. Participants will be instructed to refrain from eating after midnight before their

SMBG 27

assessment. Due to the long hours of fasting, a “diabetes friendly meal bar” will be provided

after measurements to avoid hypoglycemic episodes.

4. Self-efficacy: One of the major goals in diabetes treatment is to improve patients’ self-

efficacy in self-managing their diabetes. Self-efficacy will be measured at weeks 0 and 12

using the Stanford Patient Education Research Center Self Efficacy for Diabetes32

. The Self

Efficacy for Diabetes questionnaire32

contains 8 questions related specifically to participants

confidence in choosing appropriate foods to regulate BG, exercising for 15-30 minutes 4 to 5

times a week, knowing when changes in illness requires a doctor’s visit, and controlling

diabetes so that it does not interfere with day to day activities.

5. Summary of Diabetes self-care activities (SDSCA) questionnaire31

: This study will utilize

questions from the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire31

. The

SDSCA is a brief self-reported questionnaire of diabetes self-management activities that Self-

monitoring and Treatment Fidelity.

6. Treatment fidelity: Since self-monitoring has been found to be effective at improving BG

levels, self-monitoring will be measured as total number of weekly self-monitoring diaries

returned. Treatment fidelity will be measured as number of phone calls made to each

participant delivering the intervention.

7. Food Record: Participants will be instructed to record three days worth of all food intake;

preferably two non working weekdays and weekend. The food records will serve as an

objective measurement to indentify improvement in eating habits and adherence to the

dietary prescription from 0 to 3 months. Food records and instruction on how to record food

intake will be provided. In addition, participants will be provided with materials on food

portions to help with estimations of food intake.

SMBG 28

8. Physical Activity: Since physical activity is important in weight loss and insulin sensitivity6,

participants will be encouraged to focus efforts on increasing physical activity. Self-reported

leisure time activity will be assessed using the Paffenbarger Activity Questionnarie33

. The

Paffenbarger Activity Questionnaire specifically contains items about flights of stairs

climbed, blocks walked, and other leisure activities are included. The questionnaire can

provide and estimate of calories expended per week in overall leisure time activity and in

activities of light (5 kcals/min), medium (7.5 kcals/min), and high (10 kcals/min) intensity.

9. Quality of Life: The impact that a chronic disease such as diabetes may have on an

individual’s ability to carry out daily and social activities is of importance39

. For this reason,

measurement of quality of life will be taken using the Audit of Diabetes Dependent Quality

of Life (ADDQoL)40

at weeks 0 and 12. The ADDQoL40

is a validated 13 item

questionnaire that measures the effects of diabetes and its treatment on a participant’s quality

of life (QoL).

Table 3: Measurement plan

*Summary of Diabetes Self-Care Activities

Variables Time (week) 0 1 2 3 4 5 6 7 8 9 10 11 12 Baseline Behavioral Intervention Post-treatment

Demographics X

Weight X X

Height X

BMI X X

General History X

Blood Glucose X X

SDSCA* X X

Diaries X X X X

X X X X X X X X X

Food record X X

Physical Activity X X

Self-Efficacy X X

Quality of Life X X

SMBG 29

STATISTICAL ANALYSIS

A series of independent t-tests and Chi-square tests will be used to analyze differences between

the conditions (i.e. SR vs. SM) on baseline characteristics relevant to the investigation. If there

are a significant baseline characteristics differences, and these characteristics are related to the

dependent variable in the analysis, they will be used as covariates in analyses. Additionally, it is

anticipated that the continuous outcome variables will have Gaussian (normal) distributions.

Residual plots will be analyzed for departures from normality, and transformations will be

conducted as necessary. Finally, since the primary goal of most of the analyses is to compare

variables between the two treatment groups, treatment comparisons will be made using the

intention to treat principle, using predominantly mixed repeated measures analyses of variance

(ANOVAs), with treatment condition (Self-Regulation vs. Self-Monitoring) as the between-

subject factor and time as the within-subject factor ( 0 and 12 weeks). Pair-wise comparisons of

the treatment conditions, using bonferroni corrections, will be conducted at each time point to

determine when treatment condition differences occur. Differences in self-monitoring will also

be analyzed using independent t-tests. Alpha set at 0.05 and uses SPSS (version 16.0) for

analyses.

SMBG 30

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