Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-04-12 @ 5:08 PM
Study NCT ID:
NCT00561158
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2007-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eat Well Live Well Nutrition Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '1998-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-14', 'studyFirstSubmitDate': '2007-11-19', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight & Body Mass Index (BMI)', 'timeFrame': 'pre-, post and three month follow-up'}, {'measure': 'Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.'}], 'secondaryOutcomes': [{'measure': 'Depressive symptoms (C-ESD)', 'timeFrame': 'pre-, post and three month follow-up'}, {'measure': 'Dietary Knowledge: ten items that test knowledge of: i) fat in foods that are specific to target population; ii) Label Reading; iii) modifying recipes to lower fat content; and iv) saturated versus unsaturated fats', 'timeFrame': 'pre-, post and three month follow-up'}, {'measure': 'Eating Habits: assessed using Eating Patterns Questionnaire, a 1993 revised version of Food Habits Questionnaire developed by Kristal, Shattuck & Henry', 'timeFrame': 'pre-, post and three month follow-up'}, {'measure': 'Attitudes about fat in diet'}, {'measure': 'Cultural relevancy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes or Diabetes Prevention']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to develop and evaluate a dietary change program specifically for low-income, African-American women who are at risk for developing diabetes due to obesity. The program uses an innovative approach that emphasizes risk awareness, self-efficacy, and skills training through active learning exercises related to healthy eating. The program is delivered by peer educators in the community and addresses economic and cultural factors that are very important to program participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African-American Women\n* Aged 25-55 years\n* No current diabetes, obese (20% over ideal body weight)\n* In community neighborhoods'}, 'identificationModule': {'nctId': 'NCT00561158', 'acronym': 'EWLW', 'briefTitle': 'Eat Well Live Well Nutrition Program', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Dietary Changes in African American Women By Activation', 'orgStudyIdInfo': {'id': 'DK48134 (completed)'}, 'secondaryIdInfos': [{'id': 'R01DK048143', 'link': 'https://reporter.nih.gov/quickSearch/R01DK048143', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Behavioral: Eat Well Live Well Nutrition Program']}, {'type': 'NO_INTERVENTION', 'label': '2'}], 'interventions': [{'name': 'Eat Well Live Well Nutrition Program', 'type': 'BEHAVIORAL', 'description': '12 sessions (6 group and 6 individual)over a period of 3 months with a 3 month follow-up period. The group sessions involve active learning exercises crucial to learning and utilizing nutrition information.\n\nThe group sessions included are:\n\n* Rate Your Plate: determining high fat foods\n* Label Reading: reading food labels\n* Comparison Shopping: using unit pricing labels maximize nutritional value on a limited income\n* Recipe Modification: preparing old recipes in new ways to reduce fat\n* Eating Out: order healthier fast foods\n* Coping with High Risk Situations: coping with situations in which these new habits may be threatened\n\nSix individual sessions will introduce participants to low fat eating patterns or ways to lower fat in their diet, including:\n\n* Substituting fat-modified foods for high fat foods\n* Avoiding fat as a seasoning or flavoring\n* Avoiding fried foods\n* Modifying meat\n* Replacing high fat foods with fruits, vegetables, grains and breads', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wendy F Auslander, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'St. Louis University', 'class': 'OTHER'}, {'name': 'Grace Hill Health Centers, Inc.', 'class': 'OTHER'}]}}}