Eat Well Live Well Nutrition Program (EWLW)

January 14, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Dietary Changes in African American Women By Activation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

398

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
No Intervention: 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight & Body Mass Index (BMI)
Time Frame: pre-, post and three month follow-up
pre-, post and three month follow-up
Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.

Secondary Outcome Measures

Outcome Measure
Time Frame
Depressive symptoms (C-ESD)
Time Frame: pre-, post and three month follow-up
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
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
pre-, post and three month follow-up
Attitudes about fat in diet
Cultural relevancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

St. Louis University
Grace Hill Health Centers, Inc.

Investigators

  • Principal Investigator: Wendy F Auslander, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1994

Study Completion (Actual)

May 1, 1998

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (Estimate)

November 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • DK48134 (completed)
  • R01DK048143 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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