Clinical trial NCT00622310: Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
Official title: Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total daily energy expenditure, assessed using doubly labeled water
timeFrame: Prior to exercise intervention, and 6 months
Secondary outcomes:
measure: Total daily activity thermogenesis
timeFrame: Prior to exercise intervention, and 6 months
measure: Body weight and composition
timeFrame: Prior to exercise intervention, and 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado Division of Endocrinology, Metabolism, and Diabetes/Division of Geriatrics
name: Edward Melanson, PhD
role: PRINCIPAL_INVESTIGATOR
References: