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T h e n e w e n g l a n d j o u r n a l o fmedicine

n engl j med 367;15 nejm.org october 11, 2012 1407

original article

A Randomized Trial of Sugar-Sweetened

Beverages and Adolescent Body WeightCara B. Ebbeling, Ph.D., Henry A. Feldman, Ph.D., Virginia R. Chomitz, Ph.D.,Tracy A. Antonelli, M.P.H., Steven L. Gortmaker, Ph.D.,

Stavroula K. Osganian, M.D., Sc.D., and David S. Ludwig, M.D., Ph.D.

From the New Balance Foundation Obe-sity Prevention Center (C.B.E., D.S.L.)and the Clinical Research Center (H.A.F.,T.A.A., S.K.O.), Boston Childrens Hospi-

tal, Boston; the Institute for CommunityHealth, Cambridge (V.R.C.); and the De-partment of Society, Human Develop-ment, and Health, Harvard School ofPublic Health, Boston (S.L.G.) all inMassachusetts. Address reprint requeststo Dr. Ludwig at the New Balance Foun-dation Obesity Prevention Center, Bos-ton Childrens Hospital, 300 LongwoodAve., Boston, MA 02115, or at [email protected].

This article was published on September21, 2012, at NEJM.org.

N Engl J Med 2012;367:1407-16.

DOI: 10.1056/NEJMoa1203388Copyright 2012 Massachusetts Medical Society.

A B S T RA C T

Background

Consumption of sugar-sweetened beverages may cause excessive weight gain. Weaimed to assess the effect on weight gain of an intervention that included the provi-sion of noncaloric beverages at home for overweight and obese adolescents.

Methods

We randomly assigned 224 overweight and obese adolescents who regularly con-sumed sugar-sweetened beverages to experimental and control groups. The experi-mental group received a 1-year intervention designed to decrease consumption ofsugar-sweetened beverages, with follow-up for an additional year without interven-tion. We hypothesized that the experimental group would gain weight at a slowerrate than the control group.

Results

Retention rates were 97% at 1 year and 93% at 2 years. Reported consumption ofsugar-sweetened beverages was similar at baseline in the experimental and control

groups (1.7 servings per day), declined to nearly 0 in the experimental group at 1 year,and remained lower in the experimental group than in the control group at 2 years.The primary outcome, the change in mean body-mass index (BMI, the weight in ki-lograms divided by the square of the height in meters) at 2 years, did not differ sig-nificantly between the two groups (change in experimental group minus change incontrol group, 0.3; P = 0.46). At 1 year, however, there were significant between-group differences for changes in BMI (0.57, P = 0.045) and weight (1.9 kg, P = 0.04).We found evidence of effect modification according to ethnic group at 1 year (P = 0.04)and 2 years (P = 0.01). In a prespecified analysis according to ethnic group, amongHispanic participants (27 in the experimental group and 19 in the control group),there was a significant between-group difference in the change in BMI at 1 year(1.79, P = 0.007) and 2 years (2.35, P = 0.01), but not among non-Hispanic partici-

pants (P>0.35 at years 1 and 2). The change in body fat as a percentage of total weightdid not differ signif icantly between groups at 2 years (0.5%, P = 0.40). There were noadverse events related to study participation.

Conclusions

Among overweight and obese adolescents, the increase in BMI was smaller in theexperimental group than in the control group after a 1-year intervention designedto reduce consumption of sugar-sweetened beverages, but not at the 2-year follow-up (the prespecified primary outcome). (Funded by the National Institute of Diabe-tes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number,NCT00381160.)

The New England Journal of Medicine

Downloaded from nejm.org on October 21, 2012. For personal use only. No other uses without permission.

Copyright 2012 Massachusetts Medical Society. All rights reserved.

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n engl j med 367;15 nejm.org october 11, 20121408

The consumption of sugar-sweet-

ened beverages among adolescents1 hasincreased in tandem with the prevalence

of pediatric obesity in the United States,2 sug-gesting a causal relationship. At present, a sub-stantial proportion of high-school students ha-bitually consume sugar-sweetened beverages,

including carbonated soda, sports drinks, energydrinks, and highly sweetened coffees and teas.3Sugar-sweetened beverages are the leadingsource of added sugar in the diet of a wide rangeof racial and ethnic groups.4 According to na-tionally representative data, overweight andobese adolescents obtain more than 300 kcal perday from these products, amounting to an aver-age of 15% of their total daily energy intake.5

Short-term feeding studies show greater en-ergy intake and weight gain with the consump-tion of sugar-sweetened beverages than with

beverages containing artificial sweeteners,6 andprospective observational studies show positiveassociations with the risk of obesity and relatedcomplications.7 However, the findings from therelatively few randomized, controlled trials de-signed to examine the effects of sugar-sweet-ened beverages on body weight have not beenconclusive,8-10 and the use of public health mea-sures to reduce the consumption of sugar-sweet-ened beverages remains controversial.11,12

We previously conducted a 6-month pilotstudy10 involving normal-weight, overweight,and obese adolescents who consumed sugar-sweetened beverages habitually. The experimen-tal group received home delivery of noncaloricbeverages, and the control group did not. Themean body-mass index (BMI, the weight in kilo-grams divided by the square of the height inmeters) decreased significantly in the experi-mental group, as compared with the controlgroup, only among the overweight and obeseadolescents. The current study, which is a fol-low-up to the pilot study,10 was designed to test

the hypothesis that overweight and obese ado-lescents who received an intervention to reducethe consumption of sugar-sweetened beverageswould gain weight at a slower rate than thosewho did not receive the intervention. We exam-ined prespecified covariates as potential effectmodifiers and mediators. In addition, we reana-lyzed data from an observational study13 involv-ing 548 middle-school students to corroboratethe findings of the current study.

Methods

Study Design

We randomly assigned participants to an experi-mental group or a control group for 2 years. Thestudy included a 1-year intervention and a 1-yearfollow-up, with assessment of study outcomes at

the end of each period. The institutional reviewboard at Boston Childrens Hospital approved thestudy protocol (available with the full text of thisarticle at NEJM.org). Parents provided written in-formed consent, and participants provided writ-ten assent. Beverages for the intervention groupwere purchased from an online delivery service(Peapod) affiliated with a supermarket chain.The study was conducted between October 2007and December 2011. The first two authors andthe last author vouch for the accuracy and com-pleteness of the data and analysis and the fidelity

of the study to the protocol.

Participants

We enrolled 224 adolescents (124 boys and 100girls) who reported consuming at least one serv-ing (12 oz) per day of sugar-sweetened beveragesor 100% fruit juice. Additional inclusion criteriawere enrollment in grade 9 or 10 and a BMI at orabove the 85th percentile for sex and age.14 Dur-ing telephone conversations with parents, wecollected demographic information, includingsex, date of birth, race (white, black, Asian, mul-tiple, or other), ethnic group (Hispanic or non-Hispanic), parents level of education, and totalannual household income.

Intervention

We used a multicomponent intervention de-signed to reduce the consumption of sugar-sweetened beverages in the experimental group.The emphasis was on displacing sugar-sweet-ened beverages with noncaloric beverages in thehome as a strategy to decrease consumption.5

The 1-year intervention consisted of home deliv-ery of noncaloric beverages (e.g., bottled water anddiet beverages) every 2 weeks, monthly motiva-tional telephone calls with parents (30 minutesper call), and three check-in visits with participants(20 minutes per visit). Written intervention mes-sages with instructions to drink the deliveredbeverages and not to buy or drink sugar-sweet-ened beverages were mailed to participants. Un-sweetened water was recommended over artifi-




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Sugar-Sweetened Beverages a nd Adolescent Body Weight


cially sweetened beverages. Discussions duringtelephone calls and check-in visits focused exclu-sively on beverage consumption, with no atten-tion to other dietary behaviors or to physical ac-tivity. We mailed $50 supermarket gift cards toparticipants in the control group at 4 and 8 monthsas a retention strategy but did not provide in-

structions on what to purchase with the cards.

Outcomes

All personnel who assessed study outcomes wereunaware of the group assignments. The primaryoutcome was the change in BMI at 2 years. To cal-culate BMI, trained personnel measured weightand height using calibrated scales and stadiome-ters, respectively. We used data from bioelectricalimpedance analysis (BIA) and the equation of Sunet al.15 to calculate body fat as a percentage oftotal body weight. In three telephone interviews

conducted at each assessment (baseline, 1 year, and2 years), participants were asked to recall theirdietary intake and physical activity during the pre-ceding 24 hours. Dietary intake data were col-lected with Nutrition Data System for Research(NDSR) software, versions 2006 through 2011,developed by the Nutrition Coordinating Center,University of Minnesota, Minneapolis. Final calcu-lations were completed with NDSR, version 2011.Variables used to assess dietary quality includedreported daily servings of sugar-sweetened, arti-ficially sweetened, and unsweetened beverages;servings of 100% fruit juices; total energy andsugar intakes; and energy intake from sugar-sweetened beverages and 100% fruit juices. Theinterviewer also asked each participant to recallthe activity performed most often during each15-minute block throughout the previous day.16,17We calculated a daily physical-activity factor, usingmetabolic equivalent (MET) levels for each re-ported activity,18 and hours of television viewing.

Adverse Events

An adverse event was defined as any symptom orsafety concern requiring medical attention thatwas reported by an adolescent or a parent duringparticipation in the study.

Statistical Analysis

The trial was designed to have 80% power at atype I error rate of 5% to detect a net interventioneffect with respect to the primary outcome BMIof 0.49, as attained with a shorter intervention in

our pilot study.10 All analyses followed the inten-tion-to-treat principle. Baseline demographiccharacteristics, dietary intake, and obesity-relat-ed behavioral variables were compared betweenthe experimental and control groups with theuse of Students t-test and Fishers exact test forcontinuous and categorical variables, respective-

ly. Changes in BMI and other anthropometricoutcomes were compared between groups with ageneral linear model, adjusted for baseline co-variates that could affect body weight. We per-formed identical but separate analyses for thechange from baseline after 1 year (intervention pe-riod) and the change from baseline after 2 years(follow-up period without further intervention).Dietary intakes and obesity-related behavioraloutcomes were analyzed similarly, without ad-justment for covariates. Residual analysis con-firmed that the assumption of normal error was

satisfied. The net intervention effect (the meanchange in the experimental group minus the meanchange in the control group) was calculated fromthe parameters of the fitted model.

We tested each covariate for interaction and,finding Hispanic ethnic group to be the sole sig-nificant effect modifier for between-group dif-ferences in the change in BMI, we constructedadditional ethnicity-specific summary statisticsfor the anthropometric and behavioral outcomesfrom a model that included an interaction termfor study group and ethnic group. Testing 14covariates for effect modification with a criticalvalue of P

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adjusted for total energy intake and controlledfor baseline consumption; baseline fat and changein fat, expressed as a percentage of total energyintake; and baseline energy-adjusted intake offruit juice and change in fruit-juice intake), demo-graphic characteristics (age, sex, ethnic group,and race, with indicator variables for schools),

anthropometric variables (BMI and triceps skin-fold thickness), physical activity (exercising to loseweight at baseline [yes or no], number of physi-cal-education classes per week at baseline, andbaseline physical activity [

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Table 1. Baseline Characteristics of the Study Participants.*

CharacteristicExperimental

Group (N = 110)Control Group

(N = 114) P Value

Sex no. (%)

Male 58 (53) 66 (58) 0.50

Female 52 (47) 48 (42)

Race or ethnic group no. (%)

Race

White 60 (55) 64 (56) 0.99

Black 26 (24) 27 (24)

Asian 4 (4) 4 (4)

Multiple or other 20 (18) 19 (17)

Ethnic group

Hispanic 27 (25) 19 (17) 0.19

Non-Hispanic 83 (75) 95 (83)

Age yr 15.30.7 15.20.7 0.50

Weight kg 85.216.8 86.117.0 0.70

Height cm 167.48.8 168.99.1 0.21

BMI 30.45.2 30.14.7 0.64

Weight status

Overweight 40 (36) 44 (39) 0.78

Obese 70 (64) 70 (61)

Body fat % of total weight 31.98.3 31.28.2 0.55

Annual household income no. (%)

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Table 2. Dietary Intake.*

Intake Unadjusted Data Change from Baseline

Baseline 1 Yr 2 Yr 1 Yr P Value 2 Yr P Value

Beverages (servings/day)

Sugar-sweetened

Experimental group 1.70.9 0.20.4 0.40.5 1.50.1

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Table 3. Study Outcomes.*

Variable Unadjusted Data Change from Baseline

Baseline 1 Yr 2 Yr 1 Yr P Value 2 Yr P Value

BMI

All participants

Experimental group 30.365.24 30.505.55 31.105.94 0.060.20 0.75 0.710.28 0.01

Control group 30.054.66 30.615.37 31.035.51 0.630.20 0.001 1.000.28

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of participants available at 2 years for assessmentof the primary outcome (P = 0.29).

Changes in Dietary Intake

Changes in reported dietary intake are shown inTable 2. At 1 year, the change in consumption ofsugar-sweetened beverages was significantly dif-

ferent between the groups (P

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energy intake among overweight and obese ado-lescents after a 1-year intervention, and therewere persistent effects on diet through follow-upat 2 years. The change in BMI differed signifi-cantly between the experimental and controlgroups at 1 year but not at 2 years. We also foundevidence of effect modification according to eth-

nic group, with the change in BMI differing be-tween groups in a small sample of Hispanics butnot among non-Hispanic participants.

Multicomponent interventions, targeting sev-eral aspects of diet and physical activity to pro-mote negative energy balance, constitute a com-mon strategy for treating adolescent obesity.19,20However, most intensive interventions haveyielded disappointing results. In the presentstudy, education and behavioral counseling fo-cused specifically on decreasing consumption ofsugar-sweetened beverages, a single dietary be-

havior that may be particularly important forcontrolling body weight. The significant inter-vention effect for the change in BMI observed at1 year, together with the findings of de Ruyteret al. involving children 5 to 12 years of age(reported elsewhere in the Journal),21 providessupport for public health guidelines that recom-mend limiting consumption of sugar-sweetenedbeverages.22 The lack of effect at 2 years couldreflect increasing energy intake from sugar-sweetened beverages or fruit juices in the experi-mental group on discontinuation of the inter-vention; decreasing intake of sugar-sweetenedbeverages or fruit juices in the control group,possibly due to a secular trend resulting fromefforts to eliminate these beverages fromschools23; or both.

We examined several variables that couldconfound or mediate the effect of the interven-tion on BMI. We observed a difference in televi-sion viewing between the groups, but in ourstatistical models, this difference did not ac-count for the difference in the change in BMI at

1 year. Similarly, no covariate other than sugarintake attenuated the intervention effect, sug-gesting that sugar intake had a mediating inf lu-ence. However, we recognize that the intensityof the intervention, rather than provision of non-caloric beverages per se, may have led to salutarychanges in other behaviors, such as decreasedtelevision viewing, and that these changes mayaffect body weight.

We conducted a subgroup analysis after a

prespecified test revealed significant effect mod-ification according to ethnic group, and reanaly-sis of data from a prospective observationalstudy13 provided corroborative evidence. How-ever, these data must be interpreted cautiously inview of the small size of the Hispanic subgroup.The reason for effect modification according to

ethnic group remains speculative but may in-volve differences in physiology (e.g., involvinginsulin secretion in response to the ingestion ofsugar24-26) or in genetic susceptibility (as re-ported elsewhere in the Journal27). Still, eventhough our statistical models controlled forbaseline covariates and no effect modificationwas detected in our measures of household in-come and education, we cannot exclude the pos-sibility that effect modification according toethnic group arose from socioeconomic or be-havioral differences between ethnic groups rath-

er than from inherent physiological differences.Additional study is needed to determine whetherethnic group influences the effect of consumingsugar-sweetened beverages on body weight.

The strengths of our trial include a focus ona single dietary behavior in the home environ-ment, a diverse sample, excellent participant-retention rates, collection of data on dietaryprocess measures, and assessment of physicalactivity and television viewing. The limitationsinclude a small sample as compared with sam-ples in multisite studies, reliance on self-report-ing of dietary intake (with the likelihood of un-derreporting)28 and physical activity, use of theBIA (a relatively inaccurate method)29 to esti-mate body fat, and lack of data on obesity-relat-ed risk factors, such as biomarkers of lipid andglucose metabolism.

In conclusion, replacement of sugar-sweetenedbeverages with noncaloric beverages did notimprove body weight over a 2-year period, butgroup differences in dietary quality and bodyweight were observed at the end of the 1-year

intervention period.The views expressed in this article are those of the authorsand do not necessarily represent the official views of the Na-tional Institute of Diabetes and Digestive and Kidney Diseases,the National Center for Research Resources, the National Insti-tute of Child Health and Human Development, the National In-stitutes of Health, or the Centers for Disease Control and Pre-vention.

Supported by grants from the National Institute of Diabetesand Digestive and Kidney Diseases (R01DK073025 andK24DK082730, to Dr. Ludwig) and from the National Center forResearch Resources to the Boston Childrens Hospital GeneralClinical Research Center (M01RR02172), the Harvard Catalyst




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Clinical and Translational Science Center (UL1RR025758), andthe New Balance Foundation. The observational study was sup-ported by grants from the National Institute of Child Health andHuman Development (HD30780), the Centers for Disease Con-trol and Prevention (1U48DP001946), and the Robert WoodJohnson Foundation (66284).

Disclosure forms provided by the authors are available withthe full text of this article at NEJM.org.

We thank Margaret Apura for organizing daily study operations

and overseeing the motivational telephone calls and check-in visits;Linda Seger-Shippee for conducting the 24-hour dietary and physi-

cal-activity recall interviews; Meredith Beard for administrativecontributions; Hope Forbes, Sarah Kalil, Melissa Gallagher, Cath-erine Matero, Elizabeth Scarola, Abigail Lukens, Katherine Wargo,and Gayathry Sooriyakumar for assistance with data collection andmanagement; Corrine Fischer for assistance with motivational tele-phone calls; administrators, nurses, and teachers at the participat-ing schools for assistance with recruitment and retention; Drs. Isa-belle Chase and Zameera Fida for facilitating recruitment in thedental clinic; Mohamad Daniar for maintaining the data-manage-

ment system; and Drs. Joseph Majzoub and Walter Willett for theirthoughtful review of a previous draft of this article.

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