Expired Study
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Lawrence, Kansas 66045


Purpose:

In order to examine potential gender differences in the weight loss response to exercise, the investigators propose to compare equal energy expenditure of exercise for overweight men and women using levels of exercise energy expenditure that the investigators have previously shown to prevent weight gain or promote weight loss. The investigators will randomize men and women to an exercise group, 5 days/week, for 9 months, with an energy expenditure of 400 kcal/exercise session, a group with 600 kcal/ exercise session, or a control group. 1)The investigators hypothesize that men and women randomized to sedentary control will gain weight, those randomized to 400 kcal/exercise session will maintain weight (will not gain), and those randomized to 600 kcal/exercise session will lose ~5% of body weight. 2) The investigators hypothesize there will be no differences for weight loss between genders at either 400 or 600 kcal of energy expenditure of exercise since men and women will have equal amounts of energy expenditure of exercise. 3) The investigators hypothesize that men and women randomized to 400 kcal/exercise session will completely compensate for the energy expended during exercise by altering energy intake and/or spontaneous activity and that men and women participants randomized to 600 kcal/exercise session will not completely compensate. The investigators believe the findings from this study could have important implications for exercise guidelines for weight loss.


Study summary:

Exercise is recommended by virtually every public health organization; however, the role of exercise is generally considered secondary to energy restriction for the treatment of obesity. Indeed, an argument can be made that suggests exercise is not effective for weight loss. Meta-analytic studies consistently find small amounts of weight loss due to exercise without energy restriction. It is critical to note that there are actually very few randomized controlled trials using exercise alone for weight loss. We believe that there are 3 critical flaws in the vast majority of the literature. 1)Participants are not supervised and is generally recorded by self report and is likely poorly estimated and in general, overestimated. 2)The amount of exercise used is usually prescribed from the guidelines for recommended levels for physical fitness and to diminish cardiovascular disease, not the amount that may be necessary for weight loss. 3)The energy expenditure of the exercise is rarely reported. Participants will be randomly assigned to expend either 400 or 600kcal per exercise session (or a control group) and will exercise 5 days per week for 9 months. All exercise sessions will be supervised and the length of the exercise session will be based upon energy expenditure (kcal/min) at a give heart rate range. To account for improvements in fitness, energy expenditure will be measured monthly and adjustments to the daily exercise prescription will be altered accordingly.


Criteria:

Inclusion Criteria: - 18 years or greater - males & females - <500kcal exercise/wk - BMI 25-40 Exclusion Criteria: - known cardiovascular and metabolic disorders, - weight altering product use - smoking - clinical depression - special diets


Study is Available At:


Original ID:

HSCL15226


NCT ID:

NCT01186523


Secondary ID:

R01DK049181


Study Acronym:


Brief Title:

Long-term Exercise, Weight Loss and Energy Balance


Official Title:

Long-term Exercise, Weight Loss and Energy Balance


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Kansas


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

136


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joseph E Donnelly, EdD
Principal Investigator
University of Kansas

Study Dates

Start Date:July 2005
Completion Date:July 2011
Completion Type:Actual
Primary Completion Date:July 2011
Primary Completion Type:Actual
Verification Date:August 2012
Last Changed Date:August 8, 2012
First Received Date:August 19, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Total Daily Energy Expenditure
Time Frame:10 months
Safety Issues:False
Description:Total daily energy expenditure will be determined using the doubly labeled water procedure
Outcome Type:Secondary Outcome
Measure:Resting Metabolic Rate
Time Frame:10 months
Safety Issues:False
Description:Resting metabolic rate will be determined via indirect calorimetry following an overnight fast.
Outcome Type:Secondary Outcome
Measure:Body Composition
Time Frame:10 months
Safety Issues:True
Description:Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA.
Outcome Type:Primary Outcome
Measure:Between group weight change at 10 months
Time Frame:10 months
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Long Term Energy Balance
Description:To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.
Arm Name:400 kcal of exercise/session
Other Name:400 kcal of exercise/session

Study Arms

Study Arm Type:Experimental
Arm Name:Control, no exercise
Description:No exercise control group
Study Arm Type:Experimental
Arm Name:600 Kcal of exercise/session
Description:600 Kcal of exercise/session
Study Arm Type:Experimental
Arm Name:400 kcal of exercise/session
Description:400 kcal of exercise/session

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Kansas
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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