Trial Outcomes & Findings for Biological Effects of Weight Loss In Older, Obese Women (NCT NCT01032733)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

24 weeks

Results posted on

2012-06-14

Participant Flow

Participants were recruited between September 2006 - December 2008 through a variety of methods including media articles, direct mailings, newspaper announcements, and presentations to community groups.

Following telephone screening, potentially eligible persons were invited to attend a screening visit during which the purposes and procedures of the study were explained and informed consent was obtained.

Participant milestones

Participant milestones
Measure	Lifestyle Counseling In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.	Educational Control Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Overall Study STARTED	17	17
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biological Effects of Weight Loss In Older, Obese Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Counseling n=17 Participants In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.	Educational Control n=17 Participants Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age Continuous	63.7 years STANDARD_DEVIATION 4.5 • n=5 Participants	63.7 years STANDARD_DEVIATION 6.7 • n=7 Participants	63.7 years STANDARD_DEVIATION 5.59 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so 'centered' with a baseline carried forward mechanism).

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.

Outcome measures

Outcome measures
Measure	Lifestyle Counseling n=17 Participants In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.	Educational Control n=17 Participants Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Performance on the 400 Meter Walk	0.16 meters per second Standard Deviation 0.03	0.02 meters per second Standard Deviation 0.03

SECONDARY outcome

Timeframe: 24 weeks

Population: Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so 'centered' with a baseline carried forward mechanism).

Body weight was measured under fasting conditions following voiding in the morning at baseline and at the 24-week post-treatment assessment.

Outcome measures

Outcome measures
Measure	Lifestyle Counseling n=17 Participants In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.	Educational Control n=17 Participants Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Body Weight	-5.95 kilograms Standard Deviation 4.1	-0.23 kilograms Standard Deviation 4.08

SECONDARY outcome

Timeframe: 24 weeks

Population: Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Counseling n=17 Participants In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.	Educational Control n=17 Participants Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Short Physical Performance Battery	1.82 score on the SPPB Standard Deviation 1.24	0.8 score on the SPPB Standard Deviation 1.20

SECONDARY outcome

Timeframe: 24 weeks

Population: Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.

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.

Outcome measures

Outcome measures
Measure	Lifestyle Counseling n=17 Participants In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.	Educational Control n=17 Participants Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Knee Extension Maximum Isokinetic Strength (Weight Lifted in Kilograms).	4.33 kilograms Standard Deviation 14.35	3.95 kilograms Standard Deviation 14.43

SECONDARY outcome

Timeframe: 24 weeks

Population: Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. In addition, the discrepancy for the number of participants is becasue we could only obtain information on a subset of participants due to the nature of the procedure (muscule biopsy).

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.

Outcome measures

Outcome measures
Measure	Lifestyle Counseling n=5 Participants In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.	Educational Control n=7 Participants Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Mitochondrial Function (Cox IV Subunit)	1.65 fold change (ug/ml) Standard Deviation 0.59	1.21 fold change (ug/ml) Standard Deviation 0.31

Adverse Events

Lifestyle Counseling

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Educational Control

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lifestyle Counseling n=17 participants at risk In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.	Educational Control n=17 participants at risk Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Musculoskeletal and connective tissue disorders Musculoskeletal	41.2% 7/17 • Number of events 7 • Adverse events were assessed between baseline and six months.	29.4% 5/17 • Number of events 5 • Adverse events were assessed between baseline and six months.

Additional Information

Stephen Anton

University of Florida

Phone: 352-273-7514

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place