search
Back to results

Long-term Exercise, Weight Loss and Energy Balance

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Long Term Energy Balance
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Weight Management, Physical Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Energy Balance Lab, The University of Kansas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

400 kcal of exercise/session

600 Kcal of exercise/session

Control, no exercise

Arm Description

400 kcal of exercise/session

600 Kcal of exercise/session

No exercise control group

Outcomes

Primary Outcome Measures

Between group weight change at 10 months

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2010
Last Updated
August 8, 2012
Sponsor
University of Kansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT01186523
Brief Title
Long-term Exercise, Weight Loss and Energy Balance
Official Title
Long-term Exercise, Weight Loss and Energy Balance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight Management, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400 kcal of exercise/session
Arm Type
Experimental
Arm Description
400 kcal of exercise/session
Arm Title
600 Kcal of exercise/session
Arm Type
Experimental
Arm Description
600 Kcal of exercise/session
Arm Title
Control, no exercise
Arm Type
Experimental
Arm Description
No exercise control group
Intervention Type
Other
Intervention Name(s)
Long Term Energy Balance
Other Intervention Name(s)
400 kcal of exercise/session, 600 kcal of exercise/session, No exercise control group
Intervention 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.
Primary Outcome Measure Information:
Title
Between group weight change at 10 months
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Body Composition
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.
Time Frame
10 months
Title
Resting Metabolic Rate
Description
Resting metabolic rate will be determined via indirect calorimetry following an overnight fast.
Time Frame
10 months
Title
Total Daily Energy Expenditure
Description
Total daily energy expenditure will be determined using the doubly labeled water procedure
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph E Donnelly, EdD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Energy Balance Lab, The University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26193059
Citation
Herrmann SD, Willis EA, Honas JJ, Lee J, Washburn RA, Donnelly JE. Energy intake, nonexercise physical activity, and weight loss in responders and nonresponders: The Midwest Exercise Trial 2. Obesity (Silver Spring). 2015 Aug;23(8):1539-49. doi: 10.1002/oby.21073.
Results Reference
derived
PubMed Identifier
26122282
Citation
Ptomey LT, Willis EA, Honas JJ, Mayo MS, Washburn RA, Herrmann SD, Sullivan DK, Donnelly JE. Validity of energy intake estimated by digital photography plus recall in overweight and obese young adults. J Acad Nutr Diet. 2015 Sep;115(9):1392-9. doi: 10.1016/j.jand.2015.05.006. Epub 2015 Jun 26.
Results Reference
derived
PubMed Identifier
23592678
Citation
Donnelly JE, Honas JJ, Smith BK, Mayo MS, Gibson CA, Sullivan DK, Lee J, Herrmann SD, Lambourne K, Washburn RA. Aerobic exercise alone results in clinically significant weight loss for men and women: midwest exercise trial 2. Obesity (Silver Spring). 2013 Mar;21(3):E219-28. doi: 10.1002/oby.20145.
Results Reference
derived

Learn more about this trial

Long-term Exercise, Weight Loss and Energy Balance

We'll reach out to this number within 24 hrs