Long-term Exercise, Weight Loss and Energy Balance

NCT ID: NCT01186523

Last Updated: 2012-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2011-07-31

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.

Conditions

Obesity

Keywords

Obesity; Weight Management; Physical Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

400 kcal of exercise/session

400 kcal of exercise/session

Group Type: EXPERIMENTAL

Long Term Energy Balance

Intervention Type: OTHER

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.

600 Kcal of exercise/session

600 Kcal of exercise/session

Group Type: EXPERIMENTAL

Long Term Energy Balance

Intervention Type: OTHER

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.

Control, no exercise

No exercise control group

Group Type: EXPERIMENTAL

Long Term Energy Balance

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

400 kcal of exercise/session; 600 kcal of exercise/session; No exercise control group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: lead

Responsible Party

Joseph Donnelly

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph E Donnelly, EdD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26193059 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26122282 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23592678 (View on PubMed)

Other Identifiers

R01DK049181

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSCL15226

Identifier Type: -

Identifier Source: org_study_id