ObesityCHOICESNCT01218503
The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss
A study testing CHOICES - obese in people with Obesity and Weight Loss, run by The Miriam Hospital at 2 sites in United States.
Trial summary
This study is designed to determine whether obese, normal weight, and successful weight loss maintainers differ in their food choice decision-making and/or executive function, and whether participation in a behavioral weight loss program leads to neural and/or behavioral changes. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Weight Control
- What is being tested?
- CHOICES - obese
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Oct 2016
- 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 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women, ages 35-55, who are either currently obese (BMI = 30-40 kg/m2), always normal weight (lifetime BMI < 25, NW) or successful weight loss maintainers who have lost 10% of their body weight and maintained that loss for at least 1 year (lifetime maximum BMI = 30-40 kg/m2)
Who cannot join
- weight loss medications, binge eating, standard MRI contraindications (e.g., metal implants, claustrophobia, pregnancy), left-handedness, food allergies, neurological or psychiatric conditions, including but not limited to schizophrenia, bipolar disorder, epilepsy, stroke and traumatic brain injury with loss of consciousness, and, among obese participants, inability to participate at two time points and lack of interest in participating in a behavioral weight loss trial
- serious current physical disease (e.g., heart disease and cancer) for which physician supervision of diet and exercise prescription is needed, physical problems that limit the ability to exercise, participation in a weight loss program in the last 2 months and intention to become pregnant in the next 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Active, not recruiting
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
- Recruiting
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
Kathryn E Demos, PhD, 401-793-8939, kathryn_demos@brown.edu
Kathryn E Demos, PhD
About this study
Official title: The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss (CHOICES)
This study is designed to determine whether obese, normal weight, and successful weight loss maintainers differ in their food choice decision-making and/or executive function, and whether participation in a behavioral weight loss program leads to neural and/or behavioral changes. The investigators will examine behavioral performance on several tasks involving decision-making and self-control in conjunction with brain imaging data acquired during a food-choice decision-making task. Participants enrolled in the behavioral weight loss program will also be assessed following the treatment.
- Conditions
- Obesity, Weight Loss, Weight Control
- Being tested
- CHOICES - obese
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOICES - obeseBehavioural
Standard group behavioral weight loss treatment
| Study group | Role | What they receive |
|---|---|---|
| CHOICES - obese | Experimental | behavioral weight loss treatment - overweight/obese females Receives: Behavioral: CHOICES - obese |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI
Measured: pre- and post-treatment in obese group, single time point for SWLM and NW
Secondary outcomes (1)
Behavioral data
Measured: pre- and post-treatment of obese group, single time point for SWLM and NW
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), California Institute of Technology
- Responsible party
- Principal investigator, Kathryn E. Demos, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218503
- Sponsor's protocol ID
- BRAIN-T32
- Other IDs
- K01DK090445
- Acronym
- CHOICES
- Status last verified
- Jul 2013
- First submitted
- 7 Oct 2010
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss (CHOICES)
- ClinicalTrials.gov ID
- NCT01218503
- Acronym / sponsor ID
- CHOICES / BRAIN-T32
- Conditions
- Obesity, Weight Loss, Weight Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), California Institute of Technology
- Study start
- Mar 2010
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 11 Oct 2010 (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.
This study is designed to determine whether obese, normal weight, and successful weight loss maintainers differ in their food choice decision-making and/or executive function, and whether participation in a behavioral weight loss program leads to neural and/or behavioral changes. The investigators will examine behavioral performance on several tasks involving decision-making and self-control in conjunction with brain imaging data acquired during a food-choice decision-making task. Participants enrolled in the behavioral weight loss program will also be assessed following the treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHOICES - obese | Experimental | Behavioral: CHOICES - obesebehavioral weight loss treatment - overweight/obese females |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women, ages 35-55, who are either currently obese (BMI = 30-40 kg/m2), always normal weight (lifetime BMI < 25, NW) or successful weight loss maintainers who have lost 10% of their body weight and maintained that loss for at least 1 year (lifetime maximum BMI = 30-40 kg/m2)
Key exclusion criteria (2 listed)
- weight loss medications, binge eating, standard MRI contraindications (e.g., metal implants, claustrophobia, pregnancy), left-handedness, food allergies, neurological or psychiatric conditions, including but not limited to schizophrenia, bipolar disorder, epilepsy, stroke and traumatic brain injury with loss of consciousness, and, among obese participants, inability to participate at two time points and lack of interest in participating in a behavioral weight loss trial
- serious current physical disease (e.g., heart disease and cancer) for which physician supervision of diet and exercise prescription is needed, physical problems that limit the ability to exercise, participation in a weight loss program in the last 2 months and intention to become pregnant in the next 6 months
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 |
|---|---|---|
| CHOICES - obeseStandard group behavioral weight loss treatment | Behavioural | CHOICES - obese |
Primary outcome
fMRI
Time frame: pre- and post-treatment in obese group, single time point for SWLM and NW
1 secondary outcome
Behavioral data
Time frame: pre- and post-treatment of obese group, single time point for SWLM and NW
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOICES - obese in people with Obesity and Weight Loss, run by The Miriam Hospital at 2 sites 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn E Demos, PhD (401-793-8939, kathryn_demos@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI (time frame: pre- and post-treatment in obese group, single time point for SWLM and NW). 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 29 Jul 2013.