ObesityNCT00488228
Behavioral Self-Regulation
A study testing self-regulation in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Obesity
- What is being tested?
- self-regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Nov 2007
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- body mass index between 27 and 40
- age between 21 and 35
Who cannot join
- report a history of eating disorder or a current eating disorder
- report a heart condition or other medical condition that would limit ability to participate in an exercise program without direct supervision from physician
- report major psychiatric diseases or organic brain syndromes
- currently participating in another weight loss program, are taking a weight loss medication, or have lost more than 5% of body weight curing last 6 months
- pregnant, lactating, or less than 6 months post-partum
- intend to move out of city within the time frame of the investigation or will miss multiple meetings during the study time frame
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Behavioral Self-Regulation for Weight Loss in Young Adults
The purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults.
- Conditions
- Obesity
- Being tested
- self-regulation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-regulationBehavioural
The current study involves a behavioral weight loss intervention tailored specifically to young adults. All participants receive calorie and activity prescriptions as well as training in behavior modification. In addition, one group receives training in self-regulation techniques using daily weighing.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants in the behavioral self-regulation intervention will receive a modified standard treatment that incorporates daily weighing and training in self-regulation methods for weight loss. All treatment modules are adapted for a young adult age group. Receives: Behavioral: self-regulation |
| 2 | Experimental | Participants in the Standard group will receive a brief version of standard behavioral weight loss treatment with treatment modules tailored to better meet the needs of young adults. Receives: Behavioral: self-regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Measured: 10 weeks and 20 weeks
Secondary outcomes (1)
eating disorder symptoms, physical activity, body image, mood symptoms, and self-efficacy about eating behavior
Measured: 10 weeks and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica G LaRose, Ph.D., Study director, The Miriam HospitalRena R Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488228
- Sponsor's protocol ID
- CMTT# 2096-07
- Status last verified
- Jan 2008
- First submitted
- 18 Jun 2007
- Last updated
- 13 Apr 2012
- Results posted
- No
Publications
Gokee-Larose J, Gorin AA, Wing RR. Behavioral self-regulation for weight loss in young adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2009 Feb 16;6:10. doi: 10.1186/1479-5868-6-10.
PubMed 19220909
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Self-Regulation for Weight Loss in Young Adults
- ClinicalTrials.gov ID
- NCT00488228
- Acronym / sponsor ID
- CMTT# 2096-07
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 20 Jun 2007 (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 pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: self-regulationParticipants in the behavioral self-regulation intervention will receive a modified standard treatment that incorporates daily weighing and training in self-regulation methods for weight loss. All treatment modules are adapted for a young adult age group. |
| 2 | Experimental | Behavioral: self-regulationParticipants in the Standard group will receive a brief version of standard behavioral weight loss treatment with treatment modules tailored to better meet the needs of young adults. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- body mass index between 27 and 40
- age between 21 and 35
Key exclusion criteria (6 listed)
- report a history of eating disorder or a current eating disorder
- report a heart condition or other medical condition that would limit ability to participate in an exercise program without direct supervision from physician
- report major psychiatric diseases or organic brain syndromes
- currently participating in another weight loss program, are taking a weight loss medication, or have lost more than 5% of body weight curing last 6 months
- pregnant, lactating, or less than 6 months post-partum
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 |
|---|---|---|
| self-regulationThe current study involves a behavioral weight loss intervention tailored specifically to young adults. All participants receive calorie and activity prescriptions as well as training in behavior modification. In addition, one group receives training in self-regulation techniques using daily weighing. | Behavioural | 1, 2 |
Primary outcome
weight change
Time frame: 10 weeks and 20 weeks
1 secondary outcome
eating disorder symptoms, physical activity, body image, mood symptoms, and self-efficacy about eating behavior
Time frame: 10 weeks and 20 weeks
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 13 Apr 2012.
- Derived from this study: PubMed 19220909Gokee-Larose J, Gorin AA, Wing RR. Behavioral self-regulation for weight loss in young adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2009 Feb 16;6:10. doi: 10.1186/1479-5868-6-10.
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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.
Jessica G LaRose, Ph.D. study director
The Miriam Hospital
Rena R Wing, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-regulation in people with Obesity, run by The Miriam Hospital 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?
The sponsor lists 2 inclusion and 6 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 13 Apr 2012. 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?
weight change (time frame: 10 weeks and 20 weeks). 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 NCT00488228, which also lists 1 linked publication.
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 13 Apr 2012.