Skip to main content
OpenTrials
Completed

NCT Number: NCT00561158

Eat Well Live Well Nutrition Program

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes or Diabetes Prevention Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Eat Well Live Well Nutrition Program

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

Primary outcomes

  1. Weight & Body Mass Index (BMI)

    Time frame: pre-, post and three month follow-up

  2. Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.

Secondary outcomes

  1. Depressive symptoms (C-ESD)

    Time frame: pre-, post and three month follow-up

  2. 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

  3. 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

  4. Attitudes about fat in diet

  5. Cultural relevancy

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • Grace Hill Health Centers, Inc.
  • St. Louis University

Registry information

Official study title

Dietary Changes in African American Women By Activation

Acronym: EWLW

Important dates

Study start
1994
Study completion
1998
First posted
Nov 20, 2007
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.