Obesity Clinical Trial
Official title:
Cooperative Lifestyle Intervention Program (CLIP)
To test the effects of exercise and weight loss on mobility disability of older overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome.
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 suffers 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) will test the effects of a physical
activity intervention and a weight loss intervention on mobility disability of overweight or
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 reduce sedentary behavior and promote weight loss. The primary aim
will be to compare the effects of the three treatment arms on the change in performance on a
400-meter walk test over the course of 18 months. Secondary aims will 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.
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