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Exercise and Weight Loss for Improving Mobility in Older Adults Who Are Obese (CLIP)

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Weight Loss
Health Education Control
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Currently living in one of the counties surrounding Winston-Salem, NC Sedentary (engages in fewer than 30 minutes of moderate structured physical activity for at least 10 minutes at a time each week) Overweight or obese, as defined by a body mass index (BMI) greater than 25 Fasting glucose level less than 140 Documented evidence of an MI, PCTA, chronic stable angina, or cardiovascular surgery (coronary artery or valvular heart disease) within the 6 months prior to study entry or an ATP III diagnosis of the metabolic syndrome Disability defined as self-reported difficulty with walking ¼ mile, climbing stairs, lifting and carrying groceries, or performing other household chores such as cleaning and yard work Does not plan to move out of the county of residence for the duration of the study Exclusion Criteria: Diagnosis of bipolar depression or schizophrenia (defined as self-reported treatment for these conditions) Currently receiving lithium or neuroleptics Evidence of unstable angina, symptomatic congestive heart failure, or exercise-induced complex ventricular arrhythmias Resting blood pressure greater than 160/100 mmHg Diagnosis of any of the following: Parkinson's disease; chronic liver disease (cirrhosis, chronic hepatitis, etc.); systemic rheumatic condition (rheumatoid arthritis, psoriatic arthritis, Reiter's disease, systemic lupus erythematosus, etc.); end stage renal disease; or other systemic diseases or abnormal laboratory values which would preclude participants from safely participating in the protocol or impair their ability to complete the study Actively being treated for cancer (other than non-melanotic skin cancer) Significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation Currently participating in or planning to participate in another medical intervention study Current alcohol abuse disorder or consumes more than 21 alcoholic drinks per week Unable to walk without assistance Unable to speak or read English Judged by the clinic staff to be unsuitable for the trial for any reason

Sites / Locations

  • Guilford County, North Carolina Cooperative Extension Center
  • Davidson County Coopertive Extension
  • Forsyth County Cooperative Extension Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Health education control

Exercise Only

Weight Loss

Arm Description

This is an education program for older adults entitles, successful aging.

Structured exercise 150 min/wk

Behavioral weight loss; goal of 7%

Outcomes

Primary Outcome Measures

400 meter walk

Secondary Outcome Measures

Full Information

First Posted
July 6, 2005
Last Updated
August 13, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00119795
Brief Title
Exercise and Weight Loss for Improving Mobility in Older Adults Who Are Obese
Acronym
CLIP
Official Title
Cooperative Lifestyle Intervention Program (CLIP)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Metabolic Syndrome X, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health education control
Arm Type
Active Comparator
Arm Description
This is an education program for older adults entitles, successful aging.
Arm Title
Exercise Only
Arm Type
Experimental
Arm Description
Structured exercise 150 min/wk
Arm Title
Weight Loss
Arm Type
Experimental
Arm Description
Behavioral weight loss; goal of 7%
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Physical activity
Intervention Description
Increase Physical Activity to 150 min/wk
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss
Other Intervention Name(s)
Diet modification
Intervention Description
Lose 7-10% of body weight and increase physical activity to 150 min/wk
Intervention Type
Behavioral
Intervention Name(s)
Health Education Control
Other Intervention Name(s)
Attention control
Intervention Description
Lectures on information relevant to successful aging
Primary Outcome Measure Information:
Title
400 meter walk
Time Frame
Measured at 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently living in one of the counties surrounding Winston-Salem, NC Sedentary (engages in fewer than 30 minutes of moderate structured physical activity for at least 10 minutes at a time each week) Overweight or obese, as defined by a body mass index (BMI) greater than 25 Fasting glucose level less than 140 Documented evidence of an MI, PCTA, chronic stable angina, or cardiovascular surgery (coronary artery or valvular heart disease) within the 6 months prior to study entry or an ATP III diagnosis of the metabolic syndrome Disability defined as self-reported difficulty with walking ¼ mile, climbing stairs, lifting and carrying groceries, or performing other household chores such as cleaning and yard work Does not plan to move out of the county of residence for the duration of the study Exclusion Criteria: Diagnosis of bipolar depression or schizophrenia (defined as self-reported treatment for these conditions) Currently receiving lithium or neuroleptics Evidence of unstable angina, symptomatic congestive heart failure, or exercise-induced complex ventricular arrhythmias Resting blood pressure greater than 160/100 mmHg Diagnosis of any of the following: Parkinson's disease; chronic liver disease (cirrhosis, chronic hepatitis, etc.); systemic rheumatic condition (rheumatoid arthritis, psoriatic arthritis, Reiter's disease, systemic lupus erythematosus, etc.); end stage renal disease; or other systemic diseases or abnormal laboratory values which would preclude participants from safely participating in the protocol or impair their ability to complete the study Actively being treated for cancer (other than non-melanotic skin cancer) Significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation Currently participating in or planning to participate in another medical intervention study Current alcohol abuse disorder or consumes more than 21 alcoholic drinks per week Unable to walk without assistance Unable to speak or read English Judged by the clinic staff to be unsuitable for the trial for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Rejeski
Organizational Affiliation
Wake Forest University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guilford County, North Carolina Cooperative Extension Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Davidson County Coopertive Extension
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27292
Country
United States
Facility Name
Forsyth County Cooperative Extension Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22773225
Citation
Brawley L, Rejeski WJ, Gaukstern JE, Ambrosius WT. Social cognitive changes following weight loss and physical activity interventions in obese, older adults in poor cardiovascular health. Ann Behav Med. 2012 Dec;44(3):353-64. doi: 10.1007/s12160-012-9390-5.
Results Reference
derived
PubMed Identifier
21263080
Citation
Rejeski WJ, Brubaker PH, Goff DC Jr, Bearon LB, McClelland JW, Perri MG, Ambrosius WT. Translating weight loss and physical activity programs into the community to preserve mobility in older, obese adults in poor cardiovascular health. Arch Intern Med. 2011 May 23;171(10):880-6. doi: 10.1001/archinternmed.2010.522. Epub 2011 Jan 24.
Results Reference
derived

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Exercise and Weight Loss for Improving Mobility in Older Adults Who Are Obese

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