Biological Effects of Weight Loss In Older, Obese Women
WL+E
2 other identifiers
interventional
34
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 obesity
Started Sep 2006
Typical duration for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 14, 2009
CompletedFirst Posted
Study publicly available on registry
December 15, 2009
CompletedResults Posted
Study results publicly available
June 14, 2012
CompletedJune 14, 2012
May 1, 2012
2.9 years
December 14, 2009
February 14, 2012
May 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance on the 400 Meter Walk
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.
24 weeks
Secondary Outcomes (4)
Body Weight
24 weeks
Short Physical Performance Battery
24 weeks
Knee Extension Maximum Isokinetic Strength (Weight Lifted in Kilograms).
24 weeks
Mitochondrial Function (Cox IV Subunit)
24 weeks
Study Arms (2)
Lifestyle Counseling
EXPERIMENTALIn the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
Educational Control
PLACEBO COMPARATORParticipants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Interventions
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).
Eligibility Criteria
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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
Related Publications (2)
Anton SD, Manini TM, Milsom VA, Dubyak P, Cesari M, Cheng J, Daniels MJ, Marsiske M, Pahor M, Leeuwenburgh C, Perri MG. Effects of a weight loss plus exercise program on physical function in overweight, older women: a randomized controlled trial. Clin Interv Aging. 2011;6:141-9. doi: 10.2147/CIA.S17001. Epub 2011 Jun 15.
PMID: 21753869RESULTWohlgemuth SE, Lees HA, Marzetti E, Manini TM, Aranda JM, Daniels MJ, Pahor M, Perri MG, Leeuwenburgh C, Anton SD. An exploratory analysis of the effects of a weight loss plus exercise program on cellular quality control mechanisms in older overweight women. Rejuvenation Res. 2011 Jun;14(3):315-24. doi: 10.1089/rej.2010.1132. Epub 2011 Jun 1.
PMID: 21631380RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations include the following: (1) the sample size was relatively small,(2)the study was not adequately powered to detect differences between African American and Caucasian women in response to the intervention, (3) inclusion of only women.
Results Point of Contact
- Title
- Stephen Anton
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen D Anton, PhD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2009
First Posted
December 15, 2009
Study Start
September 1, 2006
Primary Completion
August 1, 2009
Study Completion
October 1, 2009
Last Updated
June 14, 2012
Results First Posted
June 14, 2012
Record last verified: 2012-05