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Completed

NCT Number: NCT01186523

Long-term Exercise, Weight Loss and Energy Balance

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, 66045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long Term Energy Balance

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.

Other names: 400 kcal of exercise/session, 600 kcal of exercise/session, No exercise control group

Primary outcomes

  1. Between group weight change at 10 months

    Time frame: 10 months

Secondary outcomes

  1. 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.

  2. Resting Metabolic Rate

    Time frame: 10 months

    Resting metabolic rate will be determined via indirect calorimetry following an overnight fast.

  3. Total Daily Energy Expenditure

    Time frame: 10 months

    Total daily energy expenditure will be determined using the doubly labeled water procedure

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

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

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2010
Registry last updated
Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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