Biological Effects of Weight Loss In Older, Obese Women
Condition: Obesity; Sarcopenia
MeSH terms: Sarcopenia; Weight Loss
Intervention: Lifestyle Counseling; Educational Control
Intervention description: In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions each week.; Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss (e.g., skin protection).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 34.0
Sex: Female
Minimum age: 55 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Weight Loss; Physical Function; Oxidative Stress; Inflammation

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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).

        Exclusion Criteria:

          -  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.