Biological Effects of Weight Loss In Older, Obese Women

NCT01032733 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-06-14

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Lifestyle Counseling

In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions each week.

OTHER

Educational Control

Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss (e.g., skin protection).

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • University of Florida

    lead OTHER

Principal Investigators

  • Stephen D Anton, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-08-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01032733 on ClinicalTrials.gov