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Cooperative Lifestyle Intervention Program (CLIP) - Article


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Clinical Trial: Cooperative Lifestyle Intervention Program (CLIP)

This study is not yet open for patient recruitment.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

To test the effects of exercise and weight loss on mobility disability of 300 older (60-79 years) overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome.
Condition Intervention
Cardiovascular Diseases
Heart Diseases
Metabolic Syndrome X
Obesity
 Behavior: exercise
 Behavior: diet

MedlinePlus related topics:  Heart Diseases;   Metabolic Syndrome X;   Obesity;   Vascular Diseases

Study Type: Interventional
Study Design: Prevention, Randomized

Further Study Details: 

Study start: August 2005;  Expected completion: April 2010

BACKGROUND: Older adults make up the fastest growing segment of our population. It is estimated that by the year 2030, elderly people will make up 22% of the United States population. A large portion of older adults suffer from one or more chronic conditions that could be improved by regular physical activity, therefore research in this age group is needed.

DESIGN NARRATIVE: The Cooperative Lifestyle Intervention Program (CLIP) is designed to test the effects of a physical activity intervention and a weight loss intervention on mobility disability of 300 older (60-79 years) overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome. The public health relevance of the trial lies in the fact that the interventions will be delivered in conjunction with four Cooperative Extension Centers in counties surrounding Winston-Salem, North Carolina. CLIP will be designed as a three arm randomized controlled trial. The three 18-month treatments will include: (1) a basic health education-based control condition, (2) a group treatment program for physical activity, and (3) a lifestyle intervention designed to intervene on both sedentary behavior and weight loss. The primary aim is to compare the effects of the three treatment arms on 18-month change in performance on a six-minute walk test, a valid and reliable measure of mobility disability. Secondary aims include changes in cardiovascular risk factors, adiposity, cardiovascular fitness, physical activity, and health-related quality of life. Analyses will also be conducted to determine whether changes in the primary outcome are mediated by changes in constructs from social cognitive theory.

Eligibility

Ages Eligible for Study:  60 Years   -   79 Years,  Genders Eligible for Study:  Both
Criteria
An estimated 300 older (60-79 years) overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00119795


Study chairs or principal investigators

Walter Rejeski,  Wake Forest University   

More Information

Study ID Numbers:  197
Record last reviewed:  June 2005
Last Updated:  July 18, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00119795
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26


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December 6, 2009



Page Updated: June 20, 2006
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