Long-term Exercise, Weight Loss and Energy Balance

August 8, 2012 updated by: Joseph Donnelly, University of Kansas
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lawrence, Kansas, United States, 66045
        • Energy Balance Lab, The University of Kansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 400 kcal of exercise/session
Other: Long Term Energy Balance
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.
Other Names:
  • 400 kcal of exercise/session
  • 600 kcal of exercise/session
  • No exercise control group
Experimental: 600 Kcal of exercise/session
Other: Long Term Energy Balance
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.
Other Names:
  • 400 kcal of exercise/session
  • 600 kcal of exercise/session
  • No exercise control group
Experimental: Control, no exercise
No exercise control group
Other: Long Term Energy Balance
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.
Other Names:
  • 400 kcal of exercise/session
  • 600 kcal of exercise/session
  • No exercise control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Between group weight change at 10 months
Time Frame: 10 months
10 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Joseph E Donnelly, EdD, University of Kansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

August 9, 2012

Last Update Submitted That Met QC Criteria

August 8, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSCL15226
  • R01DK049181 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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