Long-term Exercise, Weight Loss and Energy Balance

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas
ClinicalTrials.gov Identifier:
NCT01186523
First received: August 19, 2010
Last updated: August 8, 2012
Last verified: August 2012
  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.


Condition Intervention
Obesity
Other: Long Term Energy Balance

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-term Exercise, Weight Loss and Energy Balance

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Between group weight change at 10 months [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body Composition [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Resting metabolic rate will be determined via indirect calorimetry following an overnight fast.

  • Total Daily Energy Expenditure [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Total daily energy expenditure will be determined using the doubly labeled water procedure


Enrollment: 136
Study Start Date: July 2005
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 400 kcal of exercise/session
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186523

Locations
United States, Kansas
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Joseph E Donnelly, EdD University of Kansas
  More Information

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Donnelly, Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01186523     History of Changes
Other Study ID Numbers: HSCL15226, R01DK049181
Study First Received: August 19, 2010
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Obesity
Weight Management
Physical Activity

Additional relevant MeSH terms:
Obesity
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014