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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 19, 2007

Last Updated Date

January 14, 2010

Start Date ^ICMJE

June 1994

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Weight, Height & Body Mass Index (BMI) [ Time Frame: pre-, post and three month follow-up ]

Change History

Complete list of historical versions of study NCT00561158 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Waist-Hip Ratios (WHR) [ 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Eat Well Live Well Nutrition Program

Official Title ^ICMJE

Dietary Changes in African American Women By Activation

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Diabetes or Diabetes Prevention

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A
Intervention: Behavioral: Eat Well Live Well Nutrition Program
No Intervention: 2

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

398

Completion Date

May 1998

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Female

Ages

25 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00561158

Other Study ID Numbers ^ICMJE

DK48134 (completed), R01 DK048143

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

St. Louis University
Grace Hill Health Centers, Inc.

Investigators ^ICMJE

Principal Investigator:

Wendy F Auslander, PhD

Washington University School of Medicine

Information Provided By

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

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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