Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PHYSICAL ACTIVITY IN THE TREATMENT OF OBESITY (CHANGE)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00615238
First received: February 12, 2008
Last updated: March 17, 2010
Last verified: March 2010

February 12, 2008
March 17, 2010
April 2000
March 2004   (final data collection date for primary outcome measure)
Participants were randomized to one of three diet and exercise study conditions. We were interested in which type of exercise is associated with optimal short- and long-term body composition changes. [ Time Frame: Baseline, Week-16, Week-68 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00615238 on ClinicalTrials.gov Archive Site
Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions? [ Time Frame: Baseline, week-16, week-68 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
PHYSICAL ACTIVITY IN THE TREATMENT OF OBESITY
Physical Activity in the Treatment of Obesity: A Randomized Trial

Although exercise is widely regarded as a key component in obesity treatment, few individuals seem able to adhere to exercise programs over time. In response, efforts have focused on developing new approaches to physical activity that may appeal to sedentary overweight persons. For instance, is has been shown that accumulating multiple short bouts of vigorous exercise may enhance both exercise adherence and weight loss in overweight persons. Accumulating moderate-intensity activity throughout the day may offer comparable health and weight benefits as a traditional exercise program. Public health recommendations now include the option of accumulating 30 minutes of moderate-intensity lifestyle activity for health and well-being. While these two options offer a viable alternative to those who dislike or cannot sustain continuous vigorous exercise programs, it is unclear whether the flexibility of accumulating physical activity or the vigorous intensity of the exercise is responsible for improved weight loss and long-term adherence.

The goal of this research is to extend our preliminary findings suggesting that moderate intensity lifestyle activity is an important and viable alternative to traditional structured vigorous exercise for obese dieting individuals. The primary specific aim of this project is to compare the effects of three modes of exercise on long-term weight regain. Participants will be 165 overweight men and women who are sedentary, but otherwise healthy. All participants will receive the same 16-week behavioral weight loss program and will be randomized to one of three exercise study conditions: 1) diet-plus-continuous bouts of vigorous aerobic exercise; 2) diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day; or 3) diet-plus-moderate intensity lifestyle activity accumulated throughout the day. By varying both the intensity and duration of exercise bouts, we can determine which type of exercise is associated with optimal outcomes one year later. Additional questions of interest include:

  1. Does mode of exercise influence exercise adherence?
  2. Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions?
  3. Does mode of exercise influence changes in body composition?
  4. Does mode of exercise influence exercise enjoyment and exercise self-efficacy?
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Behavioral: diet-plus-continuous bouts of vigorous aerobic exercise
    Patients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week
  • Behavioral: diet plus shorts bouts
    Patients consumed a 1200 kcal/d diet and were instructed to perform short 10 minutes bouts of aerobic exercise 4 times per week
  • Behavioral: diet plus lifestyle activity
    Patients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week.
  • Experimental: 1
    diet-plus-continuous bouts of vigorous aerobic exercise
    Intervention: Behavioral: diet-plus-continuous bouts of vigorous aerobic exercise
  • Experimental: 2
    diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day
    Intervention: Behavioral: diet plus shorts bouts
  • Experimental: 3
    diet-plus-moderate intensity lifestyle activity accumulated throughout the day
    Intervention: Behavioral: diet plus lifestyle activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
May 2004
March 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:Sedentary and >30 pounds above healthy weight. No plans to move from area for next 1.5 years. No plans for excessive travel.

-

Exclusion Criteria: recent weight loss or regular exercise (≥2 bouts per week), serious medical or psychiatric condition (cardiovascular, metabolic or orthopedic) or history of clinical depression or eating disorder.

-

Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00615238
DK53907 (completed 2004), RO1 DK 53907-01A1
No
Ross E. Andersen, Ph.D. / Professor, McGill University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Study Director: Jeremey D Walston, MD JHU School of Med
Study Director: Susan J Bartlett, PhD JHU School of Med
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP