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Physical Activity in the Treatment of Obesity (CHANGE)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet plus continuous bouts
Diet plus short bouts
Diet plus moderate lifestyle activity
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring overweight, physical activity, body composition, metabolic syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Johns Hopkins School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Diet plus continuous bouts

Diet plus short bouts

Diet plus moderate lifestyle activity

Arm Description

diet-plus-continuous bouts of vigorous aerobic exercise

diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day

diet-plus-moderate intensity lifestyle activity accumulated throughout the day

Outcomes

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.

Secondary Outcome Measures

Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions?

Full Information

First Posted
February 12, 2008
Last Updated
September 26, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00615238
Brief Title
Physical Activity in the Treatment of Obesity
Acronym
CHANGE
Official Title
Physical Activity in the Treatment of Obesity: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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: Does mode of exercise influence exercise adherence? Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions? Does mode of exercise influence changes in body composition? Does mode of exercise influence exercise enjoyment and exercise self-efficacy?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
overweight, physical activity, body composition, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet plus continuous bouts
Arm Type
Experimental
Arm Description
diet-plus-continuous bouts of vigorous aerobic exercise
Arm Title
Diet plus short bouts
Arm Type
Experimental
Arm Description
diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day
Arm Title
Diet plus moderate lifestyle activity
Arm Type
Experimental
Arm Description
diet-plus-moderate intensity lifestyle activity accumulated throughout the day
Intervention Type
Behavioral
Intervention Name(s)
Diet plus continuous bouts
Intervention Description
Patients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week
Intervention Type
Behavioral
Intervention Name(s)
Diet plus short bouts
Intervention Description
Patients consumed a 1200 kcal/d diet and were instructed to perform short 10 minutes bouts of aerobic exercise 4 times per week
Intervention Type
Behavioral
Intervention Name(s)
Diet plus moderate lifestyle activity
Intervention Description
Patients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions?
Time Frame
Baseline, week-16, week-68

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. - 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremey D Walston, MD
Organizational Affiliation
JHU School of Med
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susan J Bartlett, PhD
Organizational Affiliation
JHU School of Med
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Physical Activity in the Treatment of Obesity

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