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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Obesity; Metabolic Syndrome X
• Intervention / Treatment: Behavioral: Health Education Control; Behavioral: Exercise; Behavioral: Weight Loss

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.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Guilford County, North Carolina Cooperative Extension Center
    • Lexington, North Carolina, United States, 27292
      • Davidson County Coopertive Extension
    • Winston-Salem, North Carolina, United States, 27105
      • Forsyth County Cooperative Extension Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Health education control; This is an education program for older adults entitles, successful aging.	Behavioral: Health Education Control; Lectures on information relevant to successful aging; Other Names: Attention control
Experimental: Exercise Only; Structured exercise 150 min/wk	Behavioral: Exercise; Increase Physical Activity to 150 min/wk; Other Names: Physical activity
Experimental: Weight Loss; Behavioral weight loss; goal of 7%	Behavioral: Weight Loss; Lose 7-10% of body weight and increase physical activity to 150 min/wk; Other Names: Diet modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
400 meter walk	Measured at 18 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Walter Rejeski, Wake Forest University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 6, 2005
• First Submitted That Met QC Criteria: July 6, 2005
• First Posted (Estimate): July 14, 2005

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Heart Diseases; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: 197; R01HL076441 (U.S. NIH Grant/Contract); R01HL076441-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No