Eat Well Live Well Nutrition Program

Diabetes or Diabetes Prevention Clinical Trial

— EWLW  

Official title:

Dietary Changes in African American Women By Activation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561158
• Other study ID #: DK48134 (completed)
• Secondary ID: R01DK048143
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2007
• Last updated: January 14, 2010
• Start date: June 1994
• Est. completion date: May 1998

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: May 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• African-American Women

• Aged 25-55 years

• No current diabetes, obese (20% over ideal body weight)

• In community neighborhoods

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes or Diabetes Prevention

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Grace Hill Health Centers, Inc., St. Louis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight & Body Mass Index (BMI)		pre-, post and three month follow-up
Primary	Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.
Secondary	Depressive symptoms (C-ESD)		pre-, post and three month follow-up
Secondary	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		pre-, post and three month follow-up
Secondary	Eating Habits: assessed using Eating Patterns Questionnaire, a 1993 revised version of Food Habits Questionnaire developed by Kristal, Shattuck & Henry		pre-, post and three month follow-up
Secondary	Attitudes about fat in diet
Secondary	Cultural relevancy