Biological Effects of Weight Loss In Older, Obese Women (WL+E)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01032733
First received: December 14, 2009
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Sarcopenia
Behavioral: Lifestyle Counseling
Other: Educational Control
Phase 2

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: Biological Effects of Weight Loss Plus Exercise in Obese Older African-American Women: An Investigation of Aging-related Changes in Black and White Women

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Performance on the 400 Meter Walk [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Walking speed was assessed at baseline and 24-week assessment by the 400 Meter Walk Test, during which participants were asked to complete a standard walking course at their usual pace. Participants were permitted to stop during the walk but were not allowed to sit or receive help from others and were required to complete the course in 15 minutes.


Secondary Outcome Measures:
  • Body Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Body weight was measured under fasting conditions following voiding in the morning at baseline and at the 24-week post-treatment assessment.

  • Short Physical Performance Battery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Scores on the Short Physical Performance Battery (SPPB) were obtained at baseline and at the 24-week post-treatment assessment visit. The SPPB consists of a 4 meter walk, repeated chair stands, and three hierarchical standing balance tests. The time to complete each of the three performance measures was assigned a categorical score based on normative data, ranging from 0 to 4. A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by adding walking speed, chair stands, and balance scores.

  • Knee Extension Maximum Isokinetic Strength (Weight Lifted in Kilograms). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Maximal knee extension strength using each participant's strongest leg was measured using a Biodex. The participants were asked to develop their maximal isokinetic knee extension strength. Three trials of 5 repetitions were performed and the peak torque value was used for statistical analyses.

  • Mitochondrial Function (Cox IV Subunit) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Western blot analysis was performed to determine complex content. The amount of Cox IV subunit was determined for each Reporting Group via Western Blot analysis at baseline and week 24.


Enrollment: 34
Study Start Date: September 2006
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Counseling
In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
Behavioral: Lifestyle Counseling
In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions each week.
Other Name: Weight Loss plus Exercise Intervention
Placebo Comparator: Educational Control
Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Other: Educational Control
Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss (e.g., skin protection).
Other Name: Health Educational Group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01032733

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Stephen D Anton, PhD University of Florida
  More Information

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01032733     History of Changes
Other Study ID Numbers: 3992006, P30AG028740
Study First Received: December 14, 2009
Results First Received: February 14, 2012
Last Updated: May 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Weight Loss
Physical Function
Oxidative Stress
Inflammation

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Sarcopenia
Atrophy
Muscular Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014