Biological Effects of Weight Loss In Older, Obese Women

Completed · Phase 2

Conditions studied: Obesity, Sarcopenia

In brief

Obesity and sedentary lifestyle are associated with physical impairments and biological changes in older adults. Weight loss combined with exercise may reduce inflammation and may improve physical functioning in older adults who are overweight or obese and sedentary. However, the mechanisms by which weight change and exercise influence physical functioning and sarcopenia remain largely understudied. ions). In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions each week throughout the entire study. During each exercise session, participants engaged in both aerobic activities (i.e., walking) and lower body resistance training of moderate intensity. The participants in the educational control group attended monthly health education lectures on topics relevant to older adults. It was hypothesized that participants assigned to the WL+E intervention would 1) lose a larger amount of weight, 2) improve their physical function levels, and 3) reduce levels of oxidative stress and inflammation to a greater degree than participants assigned to the Educational Control group. Outcomes are: 1) body weight, 2) walking speed (assessed by 400 meter walk test), 3) the Short Physical Performance Battery \[SPPB\], and 4) knee extension isokinetic strength. The objectives of this pilot study are fourfold: 1) to demonstrate the feasibility, acceptability, and efficacy of the proposed WL+E intervention in a sample of 40 sedentary, obese older adults with impaired physical functioning; 2) to examine the biological effects of the intervention on inflammatory processes, oxidative stress, apoptosis, sarcopenia, muscle and body composition, muscle strength, and functional performance; 3) to determine whether the expected beneficial effects of the WL+E intervention on physical functioning are mediated by changes in inflammation, apoptosis, and sarcopenia; and 4) to determine the effect size of the WL+E intervention on key outcomes and provide the basis for sample size calculations in the planning of a larger RCT.

Key facts

Study ID

NCT01032733

Run by

University of Florida

People needed

34

Starts

2006-09-01

Expected to finish

2009-10-01

Last updated by the study team

2012-06-14

Who can join

Age: 55 and older, up to 79. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• African American or Caucasian Female
• Age between 55 - 79 years
• BMI > 28 kg/m2
• sedentary lifestyle (defined as < 20 min/week of aerobic exercise)
• mild to moderate physical impairments (score on the Short Physical
• Performance Battery between 4 - 10).

You may not qualify if…

• Weight >300 lbs.
• Weight loss > 10 lbs. within the past 6 months
• History of surgery for weight loss
• Hospitalization with the past 6 months
• Significant underlying disease likely to limit lifespan and/or increase risk of interventions (cancer or any condition with a life expectancy < 5 years with the exception of non-melanoma skin cancer; serious infectious diseases; myocardia infarction, cerebrovascular accident, or unstable angina within the past 6 months; NYHA Class 3 or 4 congestive heart failure; aortic stenosis; chronic hepatitis; cirrhosis; kidney disease; solid organ transplantation; chronic gastrointestinal disorders; fibromyalgia; chronic fatigue syndrome; major psychiatric disorder).
• Metabolic exclusions (resting blood pressure > 160/90 mmHg, fasting blood glucose > 160 mg/dl, fasting triglycerides > 400 mg/dl; patients on medication for hypertension, diabetes, or hyperlipidemia will not be excluded unless their values suggest "poor control").
• Medication exclusions (Antipsychotic agents; monoamine oxidase inhibitors; systemic corticosteroids; antibiotics for HIV or TB; chemotherapeutic drugs; or current use of prescription weight-loss drugs).
• Physical limitations likely to prevent exercise participation (use of walker; breathing problems that limit physical activity).
• Conditions or behaviors likely to affect the conduct of the trial (e.g., unwilling or unable to give informed consent; unwilling to accept random assignment; likely to move out of area within next 2 years; unable to attend weekly meetings; unwilling to complete paperwork; participation in another randomized research project; unwilling or unable to comply with study requirements or schedule)
• Contraindications to MRI (MR-incompatible implants or severe claustrophobia).
• Contraindications to muscle biopsy (i.e., lidocaine allergy)
• Presence of any other medical condition, which in the opinion of the research staff, would be incompatible with participation in the weight loss plus exercise program.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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