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Completed

NCT Number: NCT00622310

Energy Expenditure & Activity During & After Exercise-Induced Weight Loss

This project is aimed at determining whether an exercise-based weight loss intervention causes a compensation in some component of energy expenditure such that the increase in measured energy expenditure is less than the added exercise. The study will compare two separate exercise interventions to determine if this is influenced by exercise intensity.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, School of Medicine

Aurora, Colorado, 80045, United States

About this study

The primary aim of this proposed study is to determine how total daily activity thermogenesis (TDAT) and total daily energy expenditure (TDEE) are regulated in obese humans attempting to lose weight and maintain weight loss through exercise. Two exercise interventions will be compared; a structured aerobic exercise program and a walking program. exercise activity thermogenesis (EAT) will be verified, and non-exercise physical activity (NEAT), total daily activity thermogenesis (TDAT), and TDEE will be measured using state-of-the-art technologies. Subjects will be studied during a 6 month intervention period and then during a 6 month follow-up period. It is hypothesized that the walking program will have more favorable effects on TDAT and TDEE during both the intervention and follow-up periods. If the investigators hypotheses are correct, then data from the proposed study could be used to improve the effectiveness of exercise-based weight loss and weight loss maintenance programs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) 30-35.0 kg/m2
  • Age 18-45 years
  • Weight stable (<2 kg weight fluctuation during previous 6 months)
  • No regular exercise (> 1 bout of exercise/wk or participation in any sporting activities > 1 hr/wk)
  • No self-report of acute or chronic disease (diabetes, heart diseases, and joint problems in particular)
  • No current use of prescribed medications
  • No plans to relocate within the next year
  • No plans for extended travel (> 1 week) within the next 6 months
  • No tobacco use

For Females:

  • No evidence of amenorrhea (Regular menstrual cycles of 21-35 days)
  • Pre-menopausal status (self-report, to be confirmed during screening)
  • Pregnancy or lactating within the past year
  • No pregnancy or planned pregnancies; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. Women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control.

Exclusion criteria

  • Claustrphobia;
  • Any contraindication(s) to > MRI, e.g. aneurysm, cochlear implant, cardiac pacemaker, or implantable cardiac defibrillator, artificial heart valve, metallic stents, any implantable devices or shunt, weight less than 300 lbs;
  • Left Handed.

Treatment and study plan

Walking exercise

Behavioral

Subjects will be randomly assigned to either a structured, vigorous-intensity endurance exercise training program or an intermittent, low-intensity exercise program. Individualized exercise prescriptions will be designed to target an increase of 2500 kcal/wk, and the theoretical weight loss will be approximately 15 pounds (~6.8 kg) during the 6 month intervention.

Primary outcomes

  1. Total daily energy expenditure, assessed using doubly labeled water

    Time frame: Prior to exercise intervention, and 6 months

Secondary outcomes

  1. Total daily activity thermogenesis

    Time frame: Prior to exercise intervention, and 6 months

  2. Body weight and composition

    Time frame: Prior to exercise intervention, and 6 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 25, 2008
Registry last updated
Jul 12, 2021

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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