Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 1:31 PM
Study NCT ID:
NCT00381160
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2006-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-08', 'studyFirstSubmitDate': '2006-09-25', 'studyFirstSubmitQcDate': '2006-09-25', 'lastUpdatePostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index (BMI)', 'timeFrame': 'Change through 2 years'}]}, 'conditionsModule': {'keywords': ['weight loss', 'obesity', 'sugar-sweetened beverages', 'diet', 'adolescence'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '16510646', 'type': 'BACKGROUND', 'citation': 'Ebbeling CB, Feldman HA, Osganian SK, Chomitz VR, Ellenbogen SJ, Ludwig DS. Effects of decreasing sugar-sweetened beverage consumption on body weight in adolescents: a randomized, controlled pilot study. Pediatrics. 2006 Mar;117(3):673-80. doi: 10.1542/peds.2005-0983.'}, {'pmid': '22998339', 'type': 'DERIVED', 'citation': 'Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body weight. N Engl J Med. 2012 Oct 11;367(15):1407-16. doi: 10.1056/NEJMoa1203388. Epub 2012 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to examine the effect of a multi-component intervention, designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of the intervention differ between adolescents for whom 100% fruit juice vs. other products (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks) constitutes the primary source of sugar from beverages.', 'detailedDescription': "We are partnering with community organizations (including high schools) in the greater Boston area and a major regional supermarket. Participants will be 240 high school students who drink at least 1 serving of sugar-sweetened beverage (including 100% fruit juices) per day and who have a BMI ≥ 85th percentile. They will be randomly assigned to an intervention or control group. The intervention, of 1-year duration, will target the home/family environment in combination with a behavioral intervention provided during brief check-in visits. The environment will be changed by delivering non-caloric beverages to the homes of adolescents who regularly consume sugar-sweetened beverages. Parents will be counseled by telephone to serve as role models in consuming non-caloric beverages. The behavioral intervention for the adolescents will include didactic and experiential components during the check-in visits. Study outcomes will be assessed at baseline, 1 year (end of intervention period), and 2 years (end of follow-up period).\n\nAdditional relevant material based on the original proposal (NIH grant application) is provided below:\n\nEach outcome will be compared between groups using a general linear model, adjusted for baseline covariates that could affect body weight: sex, race, ethnicity (Hispanic vs non-Hispanic), household income, parents' education, BMI, beverage consumption (sugar-sweetened, artificially sweetened, unsweetened), energy intake (total, sugar-sweetened beverages, fruit juice), physical activity level, and daily television viewing. Each covariate will be tested for confounding, mediation, and interaction effects on the primary outcome. Stratum-specific estimates of the group difference will be constructed for any covariates showing significant interaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in grade 9 or 10\n* BMI ≥ 85th percentile for age and gender\n* Residing in predominately one household, with access to a working telephone\n* Consumption of 12 fluid ounces sugar-sweetened beverages (including 100% fruit juices) per day\n\nExclusion Criteria:\n\n* Sibling participating in the study\n* Intention to change location of residence during the 2 years post-randomization\n* Plans to be away from home for 5 weeks or longer during the study period\n* Physician diagnosis of a major medical illness or eating disorder\n* Chronic use of any medication that may affect body weight or composition\n* Current smoking\n* Physical, mental, or cognitive handicaps that prevent participation'}, 'identificationModule': {'nctId': 'NCT00381160', 'acronym': 'BASH', 'briefTitle': 'Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents', 'orgStudyIdInfo': {'id': 'DK73025A'}, 'secondaryIdInfos': [{'id': 'R01DK073025', 'link': 'https://reporter.nih.gov/quickSearch/R01DK073025', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Provision of non-caloric beverages to home', 'interventionNames': ['Behavioral: Reduction of sugar-sweetened beverage consumption']}, {'type': 'NO_INTERVENTION', 'label': '2'}], 'interventions': [{'name': 'Reduction of sugar-sweetened beverage consumption', 'type': 'BEHAVIORAL', 'description': 'Multi-component intervention aimed at reducing sugar-sweetened beverage consumption. Components include delivery of non-caloric beverages to home in combination with behavioral modification (telephone counseling with parent; check in visit with participant).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Cara B Ebbeing, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'David S Ludwig, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}