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Cooperative Lifestyle Programs (CLIP-II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Walter Jack Rejeski, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01547182
First received: March 1, 2012
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

The aim is to study the effects of weight loss and weight loss combined with different types of physical activity on changes in physical functioning of older adults who are at-risk for cardiovascular disease.


Condition Intervention
Cardiovascular Disease
Obesity
Physical Disability
Behavioral: Caloric restriction
Behavioral: Aerobic Training
Behavioral: Resistance Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cooperative Lifestyle Programs (CLIP-II)

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

Primary Outcome Measures:
  • 400-M walk test and Lower Leg Strength [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CT Scan [ Time Frame: November 2013-March 2017 ] [ Designated as safety issue: No ]
    This study will generate preliminary estimates of the independent effects of exercise modality during weight loss on changes in CT-derived parameters of bone density and quality (i.e. structure, strength) and serum biomarkers of bone turnover in a subset (n=60) of CLIP II participants.


Estimated Enrollment: 273
Study Start Date: March 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Weight Loss
Caloric restriction
Behavioral: Caloric restriction
Caloric restriction
Experimental: Weight Loss and Aerobic Training
Caloric restriction and walking
Behavioral: Caloric restriction
Caloric restriction
Behavioral: Aerobic Training
Walking
Experimental: Weight Loss and Resistance Training
Caloric restriction and lifting weights
Behavioral: Caloric restriction
Caloric restriction
Behavioral: Resistance Training
Lifting weights

Detailed Description:

Although aerobic exercise training (AT) has been the cornerstone of rehabilitation for patients with CVD or MetS, experts agree that with the escalating problem of obesity, prevention programs in this area need to target weight loss (WL) as well. This is reinforced by recent research of our own showing that obesity is a major risk factor for physical disability among older adults. From a translational perspective, clinical researchers have recommended that effective community partnerships are needed to deliver such programs. In response to this call, the investigators have recently completed a translational study funded by NHLBI, the Cooperative Lifestyle Intervention Program (CLIP). In this investigation, 288 obese, older adults with CVD or MetS were randomized to a successful aging control treatment (SA), AT, or AT+WL for 18-months. The primary outcome was mobility disability, assessed by performance on the 400 m Walk Test (400MWT), and our staff co-delivered the interventions with agents from 3 counties within the community infrastructure of North Carolina Cooperative Extension Centers. Whereas mobility improved significantly in the AT group compared to SA, AT+WL was superior to either SA or AT.

Building on CLIP, the investigators now propose to increase the translational significance of our interventions by having them delivered exclusively by community partners with our staff as "trainers and advisers" for desired behavior change. In addition, this study will provide the first large scale randomized controlled clinical trial to evaluate the effects of diet-induced weight loss (WL) on mobility in obese, older adults with CVD or the MetS as compared to WL combined with physical activity. The dual primary outcomes will be the 400MWT and muscle strength. Because uncertainty exists about the best approach for promoting WL in older adults due to concerns with the loss of lean mass, the design also permits a contrast between AT+WL and resistance exercise training (RT)+WL on muscle strength. Consistent with CLIP, our WL intervention will target a protein intake of 0.8 g∙kg body mass-1∙d-1. Reasons to consider RT+WL for older adults include: 1) the central role of muscle loss and decline in strength in mobility disability; 2) the underappreciated role of RT in cardiovascular health; 3) the influence of muscle mass on both resting and total energy expenditure as well as fat mass and bone health; and 5) the potential value of RT for improving mobility on tasks that depend heavily on the vertical movement of the center of mass (e.g., stair climbing). Eves and Plotnikoff22 have emphasized the importance of RT in older diseased populations and stated that "the investigators need to discover practical, sustainable, and economically viable ways to safely implement RT at the population level." To accomplish our goals, the investigators have created a community partnership with the YMCA, using 4 sites in Forsyth County, NC. One of the sites serves a large African American population. The investigators are moving this project from Cooperative Extension Centers to the YMCA because the former have neither the equipment nor the personnel necessary to independently train and monitor RT or AT.

  Eligibility

Ages Eligible for Study:   60 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Residence: community-dwelling men and women from the counties of interest (SR)
  • Age: between 60-79 yrs (SR)
  • Activity Status: sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no less than 10 minute blocks; SR)
  • Adiposity: obese as defined by a BMI ≥ 30 (OAC)
  • Medical Criteria: documented evidence of an MI, PCTI, chronic stable angina, cardiovascular surgery (coronary artery or valvular heart disease) or an ATP III diagnosis of the metabolic syndrome (PCP)
  • Mobility Disability: 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 (SR)
  • Stability of Residence: does not plan to move out of the county of residence for the duration of the study (SR)
  • Agreeableness: willing and able to participate in all aspects of the trial (SR)
  • Consents: willing to give an informed consent and sign a HIPAA authorization form (SR)

Exclusion Criteria:

  • Severe Symptomatic Heart Disease: evidence of unstable angina, symptomatic congestive heart failure, or exercise induced complex ventricular arrhythmias (PCP)
  • MI or cardiovascular procedure within the last 3-months (PCP)
  • Blood Pressure: a resting blood pressure > 160/100 mmHg (OAC)
  • Severe Systemic Disease: diagnosis of 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 (PCP)
  • Cancer: active treatment for cancer other than non-melanotic skin cancer (PCP)
  • Hearing or Sight Impairments: significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation (SR, OAC)
  • Psychiatric Illness: bipolar depression or schizophrenia (defined as self-reported treatment for these conditions), currently receiving lithium or neuroleptics (PCP)
  • Cognitive Impairment: dementia, delirium or impaired cognitive function as defined by a score on the Folstein Mini-Mental Status Exam < 21 (OAC)
  • Participation in Other Trials: currently participating in or planning to participate in another medical intervention study (SR)
  • Alcohol Intake: consuming more than 21 alcoholic drinks per week or alcoholism (SR)
  • Functional Limitations: unable to walk unassisted (SR, OAC)
  • English Literacy: unable to speak or read English
  • Clinical Center Staff Evaluation: judged to be unsuitable for the trial for any reason by the clinic staff. A participant can be excluded prior to randomization because of some unspecified health problem that has been identified that would put the patient at risk for adherence or retention. These cases are discussed with a recruitment team consisting of the person who has raised the concern, an MD, and the study PIs.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01547182

Locations
United States, North Carolina
Kernersville YMCA.
Kernersville, North Carolina, United States
Fulton YMCA
Winston-Salem, North Carolina, United States
William G. White YMCA
Winston-Salem, North Carolina, United States
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: W. Jack Rejeski, PhD Wake Forest School of Medicine
Principal Investigator: Anthony Marsh, PhD 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, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01547182     History of Changes
Other Study ID Numbers: 2R18HL076441-06
Study First Received: March 1, 2012
Last Updated: August 22, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014