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
  Purpose

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?

Condition Intervention
Obesity
Behavioral: diet-plus-continuous bouts of vigorous aerobic exercise
Behavioral: diet plus shorts bouts
Behavioral: diet plus lifestyle activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physical Activity in the Treatment of Obesity: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 177
Study Start Date: April 2000
Study Completion Date: May 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
diet-plus-continuous bouts of vigorous aerobic exercise
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
Experimental: 2
diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day
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
Experimental: 3
diet-plus-moderate intensity lifestyle activity accumulated throughout the day
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

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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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615238

Locations
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Study Director: Jeremey D Walston, MD JHU School of Med
Study Director: Susan J Bartlett, PhD JHU School of Med
  More Information

No publications provided

Responsible Party: Ross E. Andersen, Ph.D. / Professor, McGill University
ClinicalTrials.gov Identifier: NCT00615238     History of Changes
Other Study ID Numbers: DK53907 (completed 2004), RO1 DK 53907-01A1
Study First Received: February 12, 2008
Last Updated: March 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
overweight, physical activity, body composition, metabolic syndrome

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014