ObesityNCT00575731
Behavioral Strategies for Weight Management
A study testing Weight management strategies in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
Although studies demonstrate that people who consistently keep detailed food records are more likely to maintain their weight, few people continue to keep records given the vigilant attention needed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight management strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:(a)Web screen: Men or women of any ethnic background; age 18 years or older; body mass index (BMI) 25-39; planning to remain in the area for the next six months; not pregnant or not planning to become pregnant within the next six months; has no history of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; not currently under medical care for any of the following conditions: cardiovascular problems (stroke, heart attack, chest pain, bypass surgery, etc.); cancer (except skin cancer); diabetes; respiratory problems (chronic asthma, bronchitis, etc.); or psychiatric condition; not currently taking or stable on medications for vascular problems (such as high blood pressure); able to participate in physical activity; does not meet Diagnostic and Statistical Manual criteria for binge eating; does not have a health condition that requires a special diet; not participating in a weight-loss program; not participating in support groups that focus on weight and eating habits; not taking weight-loss medication; not participating in any other research trial; and willing to be randomly assigned to either intervention.
(b)Pre-randomization: Completes all of the following in a timely and thorough manner: baseline clinic visit, baseline questionnaires on the study website, and obtains medical approval for participation (if applicable). Exclusion Criteria:(a)Web screen: Men or women of any ethnic background; age 18 years or older; body mass index (BMI) 25-39; planning to remain in the area for the next six months; not pregnant or not planning to become pregnant within the next six months; has no history of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; not currently under medical care for any of the following conditions: cardiovascular problems (stroke, heart attack, chest pain, bypass surgery, etc.); cancer (except skin cancer); diabetes; respiratory problems (chronic asthma, bronchitis, etc.); or psychiatric condition; not currently taking or stable on medications for vascular problems (such as high blood pressure); able to participate in physical activity; does not meet Diagnostic and Statistical Manual criteria for binge eating; does not have a health condition that requires a special diet; not participating in a weight-loss program; not participating in support groups that focus on weight and eating habits; not taking weight-loss medication; not participating in any other research trial; and willing to be randomly assigned to either intervention.
(b)Pre-randomization: Completes all of the following in a timely and thorough manner: baseline clinic visit, baseline questionnaires on the study website, and obtains medical approval for participation (if applicable).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Although studies demonstrate that people who consistently keep detailed food records are more likely to maintain their weight, few people continue to keep records given the vigilant attention needed. This study will test the efficacy of an alternative approach to record keeping that may be easier for people to sustain and lead to better long-term weight management. We propose that obese adults who attempt to keep their weight within a clearly defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more likely to continue weighing themselves and remain weight stable because they have learned to self-regulate, i.e., accurately monitor changes in their weight, alert themselves when they've gained too much weight, and 'finetune' their eating and physical activity in response, but with the minimum effort and attention necessary. The primary aim for this randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are more likely to weigh themselves over the 6-month study than participants in an 8-week traditional 'Record-Keeping' program.
Read the detailed description
Although studies demonstrate that people who consistently keep detailed food records are more likely to maintain their weight, few people continue to keep records given the vigilant attention needed. This study will test the efficacy of an alternative approach to record keeping that may be easier for people to sustain and lead to better long-term weight management. We propose that obese adults who attempt to keep their weight within a clearly defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more likely to continue weighing themselves and remain weight stable because they have learned to self-regulate, i.e., accurately monitor changes in their weight, alert themselves when they've gained too much weight, and 'finetune' their eating and physical activity in response, but with the minimum effort and attention necessary. The primary aim for this randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are more likely to weigh themselves over the 6-month study than participants in an 8-week traditional 'Record-Keeping' program.
- Conditions
- Obesity
- Being tested
- Weight management strategies
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight management strategiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Fine-Tuning | Experimental | 2-month intervention (8 lifestyle counseling classes) Receives: Behavioral: Weight management strategies |
| Record-Keeping | Active comparator | 2-month intervention (8 lifestyle counseling classes) Receives: Behavioral: Weight management strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighing attitudes and behavior
Measured: 6 months
Weight fluctuations
Measured: 6 months
Secondary outcomes (1)
Psychological outcomes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJul 2006
- Primary completionApr 2008
- Study completionMay 2009
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 Stanford UniversityThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Michaela Kiernan, Stanford University
- Investigators
- Michaela Kiernan, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575731
- Sponsor's protocol ID
- SU-11082007-857
- Status last verified
- May 2015
- First submitted
- 16 Dec 2007
- Last updated
- 20 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Strategies for Weight Management
- ClinicalTrials.gov ID
- NCT00575731
- Acronym / sponsor ID
- SU-11082007-857
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Dec 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.
Although studies demonstrate that people who consistently keep detailed food records are more likely to maintain their weight, few people continue to keep records given the vigilant attention needed. This study will test the efficacy of an alternative approach to record keeping that may be easier for people to sustain and lead to better long-term weight management. We propose that obese adults who attempt to keep their weight within a clearly defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more likely to continue weighing themselves and remain weight stable because they have learned to self-regulate, i.e., accurately monitor changes in their weight, alert themselves when they've gained too much weight, and 'finetune' their eating and physical activity in response, but with the minimum effort and attention necessary. The primary aim for this randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are more likely to weigh themselves over the 6-month study than participants in an 8-week traditional 'Record-Keeping' program.
Detailed description
Although studies demonstrate that people who consistently keep detailed food records are more likely to maintain their weight, few people continue to keep records given the vigilant attention needed. This study will test the efficacy of an alternative approach to record keeping that may be easier for people to sustain and lead to better long-term weight management. We propose that obese adults who attempt to keep their weight within a clearly defined and personalized 'range', e.g., a 5-lb range between 200-205 pounds, will be more likely to continue weighing themselves and remain weight stable because they have learned to self-regulate, i.e., accurately monitor changes in their weight, alert themselves when they've gained too much weight, and 'finetune' their eating and physical activity in response, but with the minimum effort and attention necessary. The primary aim for this randomized trial will examine whether participants in an 8-week 'Fine-Tuning' program are more likely to weigh themselves over the 6-month study than participants in an 8-week traditional 'Record-Keeping' program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fine-Tuning | Experimental | Behavioral: Weight management strategies2-month intervention (8 lifestyle counseling classes) |
| Record-Keeping | Active comparator | Behavioral: Weight management strategies2-month intervention (8 lifestyle counseling classes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| Weight management strategies | Behavioural | Fine-Tuning, Record-Keeping |
Primary outcome
Weighing attitudes and behavior
Time frame: 6 months
Weight fluctuations
Time frame: 6 months
1 secondary outcome
Psychological outcomes
Time frame: 6 months
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 20 May 2015.
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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.
Michaela Kiernan principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight management strategies in people with Obesity, run by Stanford University 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 20 May 2015. 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?
Weighing attitudes and behavior (time frame: 6 months). The study lists 2 primary outcomes in all. 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 20 May 2015.