Effects of a Weight Reduction and Lifestyle Program in Older Adults

Study Overview
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Brief Summary
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This research study will assess the effects of two different programs on weight, body composition, mobility and improved health. Measures of health will include functional abilities, and physical performance. The 2 programs being tested will be provided the same physical activity program which will include aerobic activity and resistance (weight) training. The intervention study will last up to 1 year with follow-up at 6 months and yearly phone calls thereafter.

Official Title
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Effects of a Weight Reduction and Lifestyle Program in Older Adults

Conditions
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Functional Disability, Obesity, Physical Inactivity

Intervention / Treatment
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* Behavioral: Diet and physical activity
* Other: Physical activity control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 and older BMI 28 to 39.9 Sedentary lifestyle defined by formal exercise less than 3 times per week for a total of less than 90 minutes. Self report of ability to walk ¼ mile (2-3 blocks) Ability to complete the 400 meter walk without a cane or walker in less than 15 minutes Successful completion of the behavioral run-in phase which includes an activity log and a food diary Willingness to be randomized to either intervention group Willingness to attend meetings and physical activity sessions in McKeesport Exclusion Criteria: Diabetes requiring insulin, history of diabetic coma, or diabetes out of control defined as fasting blood sugar greater than 300 Severe hypertension, e.g. SBP> 180, DBP > 100 Failure to provide informed consent Nursing home resident or resident in a facility where they have no control over food choices Significant cognitive impairment, defined as a known diagnosis of dementia or a 3MSE Cognitive Function score < 80 Major psychiatric disorder Unable to communicate because of severe hearing loss or speech disorder Severe visual impairment Celiac sprue or other malabsorption syndromes Consume more than 5 alcoholic drinks per day, or more than 15 drinks per week Progressive, degenerative neurological disease Severe rheumatologic or orthopedic diseases Stroke, hip, or knee replacement, or spinal surgery within the past 4 months or planned in the next 4 months Receiving physical therapy for gait, balance, or lower extremity training Terminal illness with life expectancy of less than 12 months Currently being treated with chemotherapy or radiation for breast, cervical, colon, prostate, rectal, uterine, thyroid, or oral cancer. Participant with other types of cancers, with the exception of basal and squamous cancer are ineligible Severe pulmonary disease (i.e., lung disease requiring supplemental oxygen or oral steroid medication) or pulmonary embolism or deep vein thrombosis within the past 6 months Severe cardiac disease (i.e., congestive heart failure (NYHA Class III or IV); untreated aortic stenosis; a history of cardiac arrest, the use of a cardiac defibrillator or uncontrolled angina) Myocardial infarction, CABG, or valve replacement in the past 6 months Serious conduction disorder (3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST- segment depressions (> 3mm) on ECG Other significant co-morbid disease that the study medical officer deems severe enough to impair ability to participate in exercise based intervention Severe kidney disease that requires dialysis Develops chest pain or severe shortness of breath during 400 m walk test Member of household is already enrolled Participation in another intervention trial: participation in an observational study is permitted People who have lost more than 10 pounds in the past 4 months, or are on any drugs for the treatment of obesity Lives outside of the study site area or is planning to move in the next year Must be able to attend at least 6 of the first 8 weekly sessions.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>lifestyle weight reduction - low fat eating, low calorie and physical activity | Behavioral: Diet and physical activity<br>* lifestyle weight reduction - low fat eating, low calorie and physical activity<br>|
| Active Comparator: Control<br>physical activity plus successful aging health education | Other: Physical activity control<br>* physical activity plus successful aging health education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to walk 400 m |  | at 6 mo intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 6 month intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, physical activity, older adults, functional disability