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Adherence to Weight Loss for Hypertension in African American Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00142649
First Posted: September 2, 2005
Last Update Posted: January 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition Intervention
Cardiovascular Diseases Heart Diseases Hypertension Obesity Behavioral: diet Behavioral: physical activity

Study Type: Interventional
Study Design: Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2002
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  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): NCT00142649


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Thomas Lasater Brown University
  More Information

ClinicalTrials.gov Identifier: NCT00142649     History of Changes
Other Study ID Numbers: 250
First Submitted: September 1, 2005
First Posted: September 2, 2005
Last Update Posted: January 21, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases