Eat Well Live Well Nutrition Program (EWLW)

This study has been completed.
Sponsor:
Collaborators:
St. Louis University
Grace Hill Health Centers, Inc.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00561158
First received: November 19, 2007
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Diabetes or Diabetes Prevention
Behavioral: Eat Well Live Well Nutrition Program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dietary Changes in African American Women By Activation

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Weight & Body Mass Index (BMI) [ Time Frame: 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:
  • Depressive symptoms (C-ESD) [ Time Frame: 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 ]
  • 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 ]
  • Attitudes about fat in diet
  • Cultural relevancy

Enrollment: 398
Study Start Date: June 1994
Study Completion Date: May 1998
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African-American Women
  • Aged 25-55 years
  • No current diabetes, obese (20% over ideal body weight)
  • In community neighborhoods
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561158

Sponsors and Collaborators
St. Louis University
Grace Hill Health Centers, Inc.
Investigators
Principal Investigator: Wendy F Auslander, PhD Washington University Early Recognition Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00561158     History of Changes
Other Study ID Numbers: DK48134 (completed), R01 DK048143
Study First Received: November 19, 2007
Last Updated: January 14, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014