Food AddictionFA PilotNCT04311450
Behavioral Weight Loss Treatment for Individuals With Food Addiction
A study testing Behavioral Weight Loss (BWL) counseling in people with Food Addiction and Overweight and Obesity, run by Yale University at 1 site in United States.
Trial summary
The purpose of this research study is to examine how well an existing weight loss treatment works for individuals with food addiction. Treatment will consist of a preliminary 12-week RCT pilot of the feasibility and effectiveness of behavioral weight loss (BWL) compared to a waitlist control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Food Addiction, Overweight and Obesity, Weight Loss
- What is being tested?
- Behavioral Weight Loss (BWL) counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 30 Jun 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 25-50 kg/m2
- Meets criteria for Food Addiction (based on the self-report score from the Yale Food Addiction Scale)
- Available for the duration of the treatment (3 months)
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
- Availability of internet to participate in study interventions (i.e., electronic SMART scales)
Who cannot join
- Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
- Reports active suicidal or homicidal ideation
- Current anorexia or bulimia nervosa
- Endorsing current or history of heart trouble/chest pain.
- Breast-feeding or pregnant, or planning to become pregnant during the study.
- History of stroke or myocardial infarction.
Show all 9Show fewer
- Current or recent (within 12 months) drug or alcohol dependence
- Currently receiving effective treatment for eating or weight loss, including individual who received bariatric surgery within the past five years
- Currently participating in another clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
The purpose of this research study is to examine how well an existing weight loss treatment works for individuals with food addiction. Treatment will consist of a preliminary 12-week RCT pilot of the feasibility and effectiveness of behavioral weight loss (BWL) compared to a waitlist control.
- Conditions
- Food Addiction, Overweight and Obesity, Weight Loss
- Being tested
- Behavioral Weight Loss (BWL) counseling
- Medical subject headings
- Food Addiction, Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss (BWL) counselingBehavioural
This therapy is a weekly treatment which focuses on making gradual and modest lifestyle changes with goals of establishing regular patterns of eating, setting weekly goals, decreasing caloric intake, developing coping skills, and increasing physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss | Experimental | Behavioral: Participants randomized assigned to this arm will received 12 weeks of Behavioral Weight Loss (BWL) counseling. Receives: Behavioral: Behavioral Weight Loss (BWL) counseling |
| Waitlist Control | No intervention | Waitlist Control: Participants assigned to this arm will attend follow-up visits to control for the effect of time. Following completion of post-treatment assessment participants in the waitlist control group will be offered an abbreviated BWL treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (e.g., change in percent weight loss)
Measured: Up to 12 weeks
Food addiction (change in food addiction scores)
Yale Food Addiction Scale scores will be assessed by self-report (range of scores 0-7, higher score reflect greater food addiction symptoms)
Measured: Up to 12 weeks
Secondary outcomes (1)
Food Craving (change in food craving scores)
Food Craving Inventory scores will be assessed by self-report (range of score 0-185, higher scores reflect greater food cravings).
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Mar 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AddictionStudies of the same condition, open and under way.
- More trials run by Yale 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311450
- Sponsor's protocol ID
- 2000027229
- Acronym
- FA Pilot
- Status last verified
- Oct 2022
- First submitted
- 11 Mar 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Weight Loss Treatment for Individuals With Food Addiction
- ClinicalTrials.gov ID
- NCT04311450
- Acronym / sponsor ID
- FA Pilot / 2000027229
- Conditions
- Food Addiction, Overweight and Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Mar 2020 (actual)
- 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 research study is to examine how well an existing weight loss treatment works for individuals with food addiction. Treatment will consist of a preliminary 12-week RCT pilot of the feasibility and effectiveness of behavioral weight loss (BWL) compared to a waitlist control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss | Experimental | Behavioral: Behavioral Weight Loss (BWL) counselingBehavioral: Participants randomized assigned to this arm will received 12 weeks of Behavioral Weight Loss (BWL) counseling. |
| Waitlist Control | No intervention | –Waitlist Control: Participants assigned to this arm will attend follow-up visits to control for the effect of time. Following completion of post-treatment assessment participants in the waitlist control group will be offered an abbreviated BWL treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI 25-50 kg/m2
- Meets criteria for Food Addiction (based on the self-report score from the Yale Food Addiction Scale)
- Available for the duration of the treatment (3 months)
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
- Availability of internet to participate in study interventions (i.e., electronic SMART scales)
Key exclusion criteria (9 listed)
- Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
- Reports active suicidal or homicidal ideation
- Current anorexia or bulimia nervosa
- Endorsing current or history of heart trouble/chest pain.
- Breast-feeding or pregnant, or planning to become pregnant during the study.
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 (BWL) counselingThis therapy is a weekly treatment which focuses on making gradual and modest lifestyle changes with goals of establishing regular patterns of eating, setting weekly goals, decreasing caloric intake, developing coping skills, and increasing physical activity. | Behavioural | Behavioral Weight Loss |
Primary outcome
Weight (e.g., change in percent weight loss)
Time frame: Up to 12 weeks
Food addiction (change in food addiction scores)
Time frame: Up to 12 weeks
Yale Food Addiction Scale scores will be assessed by self-report (range of scores 0-7, higher score reflect greater food addiction symptoms)
1 secondary outcome
Food Craving (change in food craving scores)
Time frame: Up to 8 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 26 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss (BWL) counseling in people with Food Addiction and Overweight and Obesity, run by Yale 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?
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 26 Oct 2022. 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 (e.g., change in percent weight loss) (time frame: Up to 12 weeks). 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 26 Oct 2022.