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Eat Well Live Well Nutrition Program (EWLW)

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ClinicalTrials.gov Identifier: NCT00561158
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : January 15, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes or Diabetes Prevention Behavioral: Eat Well Live Well Nutrition Program Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dietary Changes in African American Women By Activation
Study Start Date : June 1994
Study Completion Date : May 1998
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561158

Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
St. Louis University
Grace Hill Health Centers, Inc.
Principal Investigator: Wendy F Auslander, PhD Washington University School of Medicine
More Information

ClinicalTrials.gov Identifier: NCT00561158     History of Changes
Other Study ID Numbers: DK48134 (completed)
R01DK048143 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010