Physical Activity in the Treatment of Obesity (CHANGE)

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?

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Diet plus continuous bouts; Behavioral: Diet plus short bouts; Behavioral: Diet plus moderate lifestyle activity

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet plus continuous bouts; diet-plus-continuous bouts of vigorous aerobic exercise	Behavioral: Diet plus continuous bouts; Patients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week
Experimental: Diet plus short bouts; diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day	Behavioral: Diet plus short 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: Diet plus moderate lifestyle activity; diet-plus-moderate intensity lifestyle activity accumulated throughout the day	Behavioral: Diet plus moderate lifestyle activity; Patients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Baseline, Week-16, Week-68

Secondary Outcome Measures

Outcome Measure	Time Frame
Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions?	Baseline, week-16, week-68

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Study Director: Jeremey D Walston, MD, JHU School of Med; Study Director: Susan J Bartlett, PhD, JHU School of Med

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: February 12, 2008
• First Submitted That Met QC Criteria: February 12, 2008
• First Posted (Estimate): February 14, 2008

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: overweight, physical activity, body composition, metabolic syndrome
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: DK53907 (completed 2004); R01DK053907 (U.S. NIH Grant/Contract)