Cooperative Lifestyle Programs (CLIP-II)



Status:Completed
Conditions:Obesity Weight Loss, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:60 - 79
Updated:11/8/2017
Start Date:March 2012
End Date:October 2016

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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.

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.

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.
We found this trial at
3
sites
Winston-Salem, North Carolina
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Winston-Salem, NC
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Kernersville, North Carolina
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Kernersville, NC
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Winston-Salem, North Carolina
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Winston-Salem, NC
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