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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Walter Jack Rejeski, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00119795
First received: July 6, 2005
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Metabolic Syndrome X
Obesity
Behavioral: Exercise
Behavioral: Weight Loss
Behavioral: Health Education Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cooperative Lifestyle Intervention Program (CLIP)

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 400 meter walk [ Time Frame: Measured at 18 months ] [ Designated as safety issue: No ]

Enrollment: 288
Study Start Date: August 2005
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Health education
This is an education program for older adults entitles, successful aging.
Behavioral: Health Education Control
Lectures on information relevant to successful aging
Other Name: Attention control
Experimental: Exercise Only Behavioral: Exercise
Increase Physical Activity to 150 min/wk
Other Name: Physical activity
Experimental: Weight Loss Behavioral: Weight Loss
Lose 7-10% of body weight and increase physical activity to 150 min/wk
Other Name: Diet modification

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.

  Eligibility

Ages Eligible for Study:   60 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119795

Locations
United States, North Carolina
Guilford County, North Carolina Cooperative Extension Center
Greensboro, North Carolina, United States, 27405
Davidson County Coopertive Extension
Lexington, North Carolina, United States, 27292
Forsyth County Cooperative Extension Center
Winston-Salem, North Carolina, United States, 27105
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Walter Rejeski Wake Forest School of Medicine
  More Information

No publications provided by Wake Forest School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Walter Jack Rejeski, Professor, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00119795     History of Changes
Other Study ID Numbers: 197, R01HL076441, R01HL076441-01
Study First Received: July 6, 2005
Last Updated: November 2, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014