Adherence to Weight Loss for Hypertension in African American Women

NCT ID: NCT00142649

Last Updated: 2008-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2007-08-31

Brief Summary

To develop a culturally tailored intervention intended to promote adherence to nutrition and physical activity regimens designed to result in weight loss for African American women.

Detailed Description

BACKGROUND:

Besides smoking cessation, weight loss and improved nutrition are the most important behavioral changes, which can lead to improved health. Weight loss is also a critically important behavioral recommendation for treating certain illnesses such as hypertension and diabetes; for recovery from stroke or myocardial infarction; and for primary prevention of these conditions as well as certain cancers. Unfortunately, adherence is very poor even with motivated patients. This is a serious issue for all but especially African American women. These diseases affect them disproportionately. They are more likely to be overweight and there is a serious scarcity of culturally appropriate programs available. Also, many of these women receive their care in high demand/low resource clinics so that any program must also be practical and affordable within these constraints.

The study is in response to a Request for Applications issued in January, 2001 on "Overcoming Barriers to Treatment Adherence in Minorities and Persons Living in Poverty."

DESIGN NARRATIVE:

The current research involves studying adherence to recommend changes in behaviors related to nutritional intake and physical activity designed to reduce weight. The investigators will develop and test two versions of a 16-session weight loss program with the content delivered by videotape. They are nearing the end of another study, SisterTalk, for which a culturally appropriate weight control program was designed in partnership with and then delivered to African American women by cable television. Based upon that previous study, they plan to address a number of specific barriers to adherence by designing one version for clinic delivery and another for home delivery. Both approaches, each addressing different adherence issues, will be compared to a Wait List Control Group at 4 and 12 months after beginning the program. The primary outcome measures are adherence to recommended nutritional behaviors and physical activity levels. The program is based upon Social Action Theory and provides the opportunity to study many of that theory's mediating variables and their relationships to specific adherence behaviors. This will include extensive process evaluation procedures.They will also gather a great deal of data concerning the specific barriers and facilitators to adherence to nutrition and physical activity recommendations encountered by low-income African American women who are hypertensive or at high risk for hypertension.

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Obesity

Study Design

• Primary Study Purpose: PREVENTION

Interventions

diet

Intervention Type: BEHAVIORAL

physical activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

No eligibility criteria

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Thomas Lasater

Role:

Brown University

Other Identifiers

250

Identifier Type: -

Identifier Source: org_study_id