Weight GainNCT00606840
Weight Gain Prevention
A study testing large changes in eating and activity and small changes in eating and activity in people with Weight Gain, run by The Miriam Hospital at 1 site in United States.
Trial summary
The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Weight Gain
- What is being tested?
- large changes in eating and activity and small changes in eating and activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2008
- 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
- Age 18-35
- Body mass index between 23 and 30
- Interested in preventing weight gain
Who cannot join
- BMI outside of range specified
- Age outside of range specified
- History of or current eating disorder or substance abuse
- Recent weight loss greater than 5% of weight
- Currently in another research study that would interfere
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Prevent Weight Gain
The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.
- Conditions
- Weight Gain
- Being tested
- large changes in eating and activity, small changes in eating and activity
- Keywords
- overweight, prevention of weight gain, young adults, self-regulation, daily weighing, weight gain prevention
- Medical subject headings
- Weight Gain, Overweight, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
large changes in eating and activityBehavioural
Behavioral self-regulation interventions to prevent weight gain in young adults.
small changes in eating and activityBehavioural
Behavioral self-regulation interventions to prevent weight gain in young adults.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One arm is a large changes group in which participants will be asked to make periodic large changes in their eating and activity, aimed at producing initial weight loss, in order to prevent weight gain over time. Receives: Behavioral: large changes in eating and activity |
| 2 | Experimental | The second arm is a small changes group in which participants will be asked to make small changes to their eating and activity and maintain these changes forever in order to prevent weight gain. Receives: Behavioral: small changes in eating and activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Measured: 8 weeks and 16 weeks
Secondary outcomes (1)
frequency of weighing, adherence to intervention, diet, activity
Measured: 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica LaRose, The Miriam Hospital
- Investigators
- Rena R Wing, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606840
- Sponsor's protocol ID
- #2018-07
- Status last verified
- Apr 2012
- First submitted
- 22 Jan 2008
- Last updated
- 13 Apr 2012
- Results posted
- No
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
- Study to Prevent Weight Gain
- ClinicalTrials.gov ID
- NCT00606840
- Acronym / sponsor ID
- #2018-07
- Conditions
- Weight Gain
- Keywords
- overweight, prevention of weight gain, young adults, self-regulation, daily weighing, weight gain prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 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.
The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: large changes in eating and activityOne arm is a large changes group in which participants will be asked to make periodic large changes in their eating and activity, aimed at producing initial weight loss, in order to prevent weight gain over time. |
| 2 | Experimental | Behavioral: small changes in eating and activityThe second arm is a small changes group in which participants will be asked to make small changes to their eating and activity and maintain these changes forever in order to prevent weight gain. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-35
- Body mass index between 23 and 30
- Interested in preventing weight gain
Key exclusion criteria (5 listed)
- BMI outside of range specified
- Age outside of range specified
- History of or current eating disorder or substance abuse
- Recent weight loss greater than 5% of weight
- Currently in another research study that would interfere
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 |
|---|---|---|
| large changes in eating and activityBehavioral self-regulation interventions to prevent weight gain in young adults. | Behavioural | 1 |
| small changes in eating and activityBehavioral self-regulation interventions to prevent weight gain in young adults. | Behavioural | 2 |
Primary outcome
weight change
Time frame: 8 weeks and 16 weeks
1 secondary outcome
frequency of weighing, adherence to intervention, diet, activity
Time frame: 8 weeks and 16 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.
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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.
Rena R Wing, Ph.D. 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 large changes in eating and activity and small changes in eating and activity in people with Weight Gain, 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 3 inclusion and 5 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: 8 weeks and 16 weeks). 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 13 Apr 2012.