Eat Well Live Well Nutrition Program - Full Text View

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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

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 II

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Dietary Changes in African American Women By Activation

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
A: Experimental	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
2: No Intervention

Arms

Assigned Interventions

A: Experimental

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

2: No Intervention

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

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

Sponsors and Collaborators

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

St. Louis University

Grace Hill Health Centers, Inc.

Investigators

Principal Investigator:

Wendy F Auslander, PhD

Washington University School of Medicine

More Information

Study ID Numbers:	DK48134, R01 DK048143
Study First Received:	November 19, 2007
Last Updated:	January 1, 2008
ClinicalTrials.gov Identifier:	NCT00561158
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009