Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119795
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2005-07-06
Brief Title:
Exercise and Weight Loss for Improving Mobility in Older Adults Who Are Obese
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Cooperative Lifestyle Intervention Program CLIP
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIP
Brief Summary:
To test the effects of exercise and weight loss on mobility disability of older overweightobese men and women who have evidence of cardiovascular disease or the metabolic syndrome
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL076441-01 | NIH | None | httpsreporternihgovquickSearchR01HL076441-01 |
| R01HL076441 | NIH | None | None |