Weight LossPhase 1/2NCT00177476
Enhancing Exercise Participation in Overweight Adults
A Phase 1/2 study testing behavioral weight loss in people with Weight Loss, run by University of Pittsburgh.
Trial summary
The purpose of this study is to examine whether behavioral strategies implemented during the adoption versus the maintenance periods of weight loss to enhance exercise participation in overweight adults are more effective than a standard behavioral intervention. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- behavioral weight loss
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to May 2006
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female or Male
- 18-55 years of age
- BMI = 25-39.9 kg/m2
- Ability to provide informed consent.
- Ability to provide consent from their personal physician to participate in this study.
Who cannot join
- Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
- Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
- Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 18 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects)
- Non-medicated resting systolic blood pressure >160 mmHg or non-medicated resting diastolic blood pressure >100 mmHg, or taking medication that would affect blood pressure.
- Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
- Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
Show all 9Show fewer
- History of myocardial infarction or valvular disease.
- Weight loss of >5% of body weight within the previous 12 months.
- History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
About this study
The purpose of this study is to examine whether behavioral strategies implemented during the adoption versus the maintenance periods of weight loss to enhance exercise participation in overweight adults are more effective than a standard behavioral intervention.
- Conditions
- Weight Loss
- Being tested
- behavioral weight loss
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral weight lossBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Secondary outcomes (4)
Fitness
physical activity
dietary intake
mediators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- John M. Jakicic, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177476
- Sponsor's protocol ID
- 1R01HL067826-01A2
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Publications
Jakicic JM, Rickman AD, Lang W, Davis KK, Gibbs BB, Neiberg R, Marcus MD. Time-based physical activity interventions for weight loss: a randomized trial. Med Sci Sports Exerc. 2015 May;47(5):1061-9. doi: 10.1249/MSS.0000000000000482.
PubMed 25160843Janney CA, Jakicic JM. The influence of exercise and BMI on injuries and illnesses in overweight and obese individuals: a randomized control trial. Int J Behav Nutr Phys Act. 2010 Jan 6;7:1. doi: 10.1186/1479-5868-7-1.
PubMed 20145731
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Exercise Participation in Overweight Adults
- ClinicalTrials.gov ID
- NCT00177476
- Acronym / sponsor ID
- 1R01HL067826-01A2
- Conditions
- Weight Loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2003
- Study completion
- May 2006
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to examine whether behavioral strategies implemented during the adoption versus the maintenance periods of weight loss to enhance exercise participation in overweight adults are more effective than a standard behavioral intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female or Male
- 18-55 years of age
- BMI = 25-39.9 kg/m2
- Ability to provide informed consent.
- Ability to provide consent from their personal physician to participate in this study.
Key exclusion criteria (9 listed)
- Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
- Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
- Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 18 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects)
- Non-medicated resting systolic blood pressure >160 mmHg or non-medicated resting diastolic blood pressure >100 mmHg, or taking medication that would affect blood pressure.
- Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
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 |
|---|---|---|
| behavioral weight loss | Behavioural | – |
Primary outcome
body weight
4 secondary outcomes
Fitness
physical activity
dietary intake
mediators
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 15 Sep 2005.
- Derived from this study: PubMed 25160843Jakicic JM, Rickman AD, Lang W, Davis KK, Gibbs BB, Neiberg R, Marcus MD. Time-based physical activity interventions for weight loss: a randomized trial. Med Sci Sports Exerc. 2015 May;47(5):1061-9. doi: 10.1249/MSS.0000000000000482.
- Derived from this study: PubMed 20145731Janney CA, Jakicic JM. The influence of exercise and BMI on injuries and illnesses in overweight and obese individuals: a randomized control trial. Int J Behav Nutr Phys Act. 2010 Jan 6;7:1. doi: 10.1186/1479-5868-7-1.
Related trials for Weight Loss
Recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Not yet recruitingPhase 4
Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s
Obesity & Overweight, Cardiometabolic Health Indicators
Not yet recruitingPhase 2
A Study to Investigate the Effect of LY4086940 Versus Placebo in Participants With Obesity or Overweight and Without Type 2 Diabetes
Obesity, Overweight
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
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.
John M. Jakicic, Ph.D. principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing behavioral weight loss in people with Weight Loss, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. 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 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
body weight. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00177476, which also lists 2 linked publications.
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 15 Sep 2005.