Eat Well Live Well Nutrition Program

NCT ID: NCT00561158

Last Updated: 2010-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-06-30
• Study Completion Date: 1998-05-31

Brief 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.

Conditions

Diabetes or Diabetes Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Eat Well Live Well Nutrition Program

Intervention Type: BEHAVIORAL

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

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• African-American Women
• Aged 25-55 years
• No current diabetes, obese (20% over ideal body weight)
• In community neighborhoods

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Louis University

OTHER

Sponsor Role: collaborator

Grace Hill Health Centers, Inc.

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Principal Investigators

Wendy F Auslander, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Other Identifiers

R01DK048143

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK48134 (completed)

Identifier Type: -

Identifier Source: org_study_id