NCT00615238

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:

  1. 1.Does mode of exercise influence exercise adherence?
  2. 2.Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions?
  3. 3.Does mode of exercise influence changes in body composition?
  4. 4.Does mode of exercise influence exercise enjoyment and exercise self-efficacy?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2000

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
Last Updated

September 28, 2017

Status Verified

March 1, 2010

Enrollment Period

3.9 years

First QC Date

February 12, 2008

Last Update Submit

September 26, 2017

Conditions

Keywords

overweight, physical activity, body composition, metabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Baseline, week-16, week-68

Study Arms (3)

Diet plus continuous bouts

EXPERIMENTAL

diet-plus-continuous bouts of vigorous aerobic exercise

Behavioral: Diet plus continuous bouts

Diet plus short bouts

EXPERIMENTAL

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

Behavioral: Diet plus short bouts

Diet plus moderate lifestyle activity

EXPERIMENTAL

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

Behavioral: Diet plus moderate lifestyle activity

Interventions

Patients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week

Diet plus continuous bouts

Patients consumed a 1200 kcal/d diet and were instructed to perform short 10 minutes bouts of aerobic exercise 4 times per week

Diet plus short bouts

Patients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week.

Diet plus moderate lifestyle activity

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

ObesityOverweightMotor ActivityMetabolic Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Jeremey D Walston, MD

    JHU School of Med

    STUDY DIRECTOR
  • Susan J Bartlett, PhD

    JHU School of Med

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 14, 2008

Study Start

April 1, 2000

Primary Completion

March 1, 2004

Study Completion

May 1, 2004

Last Updated

September 28, 2017

Record last verified: 2010-03

Locations