Biological Effects of Weight Loss In Older, Obese Women (WL+E)
|ClinicalTrials.gov Identifier: NCT01032733|
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : June 14, 2012
Last Update Posted : June 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity Sarcopenia||Behavioral: Lifestyle Counseling Other: Educational Control||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||October 2009|
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
- Performance on the 400 Meter Walk [ Time Frame: 24 weeks ]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.
- Body Weight [ Time Frame: 24 weeks ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032733
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Stephen D Anton, PhD||University of Florida|