A Phase 2 interventional study of Eat Well Live Well Nutrition Program in Diabetes or Diabetes Prevention, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed. Open to female participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-15.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 2, Interventional, and Prevention
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.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Behavioral: Eat Well Live Well Nutrition Program
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. The group sessions included are: * Rate Your Plate: determining high fat foods * Label Reading: reading food labels * Comparison Shopping: using unit pricing labels maximize nutritional value on a limited income * Recipe Modification: preparing old recipes in new ways to reduce fat * Eating Out: order healthier fast foods * Coping with High Risk Situations: coping with situations in which these new habits may be threatened Six individual sessions will introduce participants to low fat eating patterns or ways to lower fat in their diet, including: * Substituting fat-modified foods for high fat foods * Avoiding fat as a seasoning or flavoring * Avoiding fried foods * Modifying meat * Replacing high fat foods with fruits, vegetables, grains and breads
Weight & Body Mass Index (BMI)
Time frame: pre-, post and three month follow-up
Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.
Depressive symptoms (C-ESD)
Time frame: pre-, post and three month follow-up
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
Time frame: pre-, post and three month follow-up
Eating Habits: assessed using Eating Patterns Questionnaire, a 1993 revised version of Food Habits Questionnaire developed by Kristal, Shattuck & Henry
Time frame: pre-, post and three month follow-up
Attitudes about fat in diet
Cultural relevancy
No study locations are listed for this record.
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)