ObesityCHANGENCT00615238
Physical Activity in the Treatment of Obesity
A study testing Diet plus continuous bouts, Diet plus short bouts and Diet plus moderate lifestyle activity in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Diet plus continuous bouts, Diet plus short bouts and Diet plus moderate lifestyle activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to May 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: 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:
- 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?
- Conditions
- Obesity
- Being tested
- Diet plus continuous bouts, Diet plus short bouts, Diet plus moderate lifestyle activity
- Keywords
- overweight, physical activity, body composition, metabolic syndrome
- Medical subject headings
- Obesity, Overweight, Motor Activity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet plus continuous boutsBehavioural
Patients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week
Diet plus short boutsBehavioural
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 moderate lifestyle activityBehavioural
Patients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week.
| Study group | Role | What they receive |
|---|---|---|
| Diet plus continuous bouts | Experimental | diet-plus-continuous bouts of vigorous aerobic exercise Receives: Behavioral: Diet plus continuous bouts |
| Diet plus short bouts | Experimental | diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day Receives: Behavioral: Diet plus short bouts |
| Diet plus moderate lifestyle activity | Experimental | diet-plus-moderate intensity lifestyle activity accumulated throughout the day Receives: Behavioral: Diet plus moderate lifestyle activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week-16, Week-68
Secondary outcomes (1)
Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions?
Measured: Baseline, week-16, week-68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startApr 2000
- Primary completionMar 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeremey D Walston, MD, Study director, JHU School of MedSusan J Bartlett, PhD, Study director, JHU School of Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615238
- Sponsor's protocol ID
- DK53907 (completed 2004)
- Other IDs
- R01DK053907
- Acronym
- CHANGE
- Status last verified
- Mar 2010
- First submitted
- 12 Feb 2008
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in the Treatment of Obesity: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00615238
- Acronym / sponsor ID
- CHANGE / DK53907 (completed 2004)
- Conditions
- Obesity
- Keywords
- overweight, physical activity, body composition, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Apr 2000
- Primary completion
- Mar 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet plus continuous bouts | Experimental | Behavioral: Diet plus continuous boutsdiet-plus-continuous bouts of vigorous aerobic exercise |
| Diet plus short bouts | Experimental | Behavioral: Diet plus short boutsdiet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day |
| Diet plus moderate lifestyle activity | Experimental | Behavioral: Diet plus moderate lifestyle activitydiet-plus-moderate intensity lifestyle activity accumulated throughout the day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet plus continuous boutsPatients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week | Behavioural | Diet plus continuous bouts |
| Diet plus short boutsPatients consumed a 1200 kcal/d diet and were instructed to perform short 10 minutes bouts of aerobic exercise 4 times per week | Behavioural | Diet plus short bouts |
| Diet plus moderate lifestyle activityPatients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week. | Behavioural | Diet plus moderate lifestyle activity |
Primary outcome
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
1 secondary outcome
Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions?
Time frame: Baseline, week-16, week-68
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremey D Walston, MD study director
JHU School of Med
Susan J Bartlett, PhD study director
JHU School of Med
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet plus continuous bouts, Diet plus short bouts and Diet plus moderate lifestyle activity in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.