CompletedNot Applicable

Food Addiction Clinical Treatment Program

United States2 participantsStarted 2023-03-21

Plain-language summary

The purpose of this current study is to establish the feasibility of, and preliminary support for, a clinical treatment program utilizing interventions from various empirically supported treatments for obesity-related eating disorders and substance use disorders

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 25 * BMI \>25 * YFAS \> 6/11 (severe range) * willing to commit to a 16 week group therapy program from 4 - 5:30 pm on Thursdays in Winston-Salem, NC * English speaking Exclusion Criteria: * Current participation in professional weight loss program and unwillingness to suspend it for 16 weeks during treatment * obesity medications with exception of diabetes medication with weight loss benefit (ie metformin), * current nicotine use or substance use disorder (based on meeting the clinical cutoff for the Alcohol Use Disorders Identification Test and/or Cannabis Use Disorder Identification Test * history of weight loss surgery, * current/history of severe mental illness (\> 3 psychiatric hospitalizations since age 18, * schizoaffective disorder, bipolar disorder, psychotic disorder, or personality disorder), * current/history of lithium, abilify, saphris, vraylor, clozaril, latuda, zyprexa, seroquel, risperdal, or Geodon, * current pregnancy or breastfeeding, * prior diagnosis of anorexia nervosa, diagnosis of bulimia nervosa in the last 5 years, * high currents rates of restrictive eating disorder symptoms based on the Eating Disorder Diagnosis Scale (EDDS; (i.e., any endorsement of vomiting or laxative/diuretic use to manage weight and endorsement of fasting or excessive exercise more than 2 or 3 times a week)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Yale Food Addiction Scale 2.0 (YFAS)

Timeframe: pre 16-week intervention

Yale Food Addiction Scale 2.0 (YFAS)

Timeframe: post 16-week intervention

Weight Self-Stigma Questionnaire (WSSQ)

Timeframe: pre 16-week intervention

Weight Self-Stigma Questionnaire (WSSQ)

Timeframe: post 16-week intervention

Patient Health Questionnaire (PHQ-9) with suicide question removed

Timeframe: pre 16-week intervention

Patient Health Questionnaire (PHQ-9) with suicide question removed

Timeframe: post 16-week intervention

Generalized Anxiety Disorder (GAD-7)

Timeframe: pre 16-week intervention

Trial details

NCT IDNCT04373343

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-07

View on ClinicalTrials.gov More Food Addiction trials

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Yale Food Addiction Scale 2.0 (YFAS)

Timeframe: pre 16-week intervention

Yale Food Addiction Scale 2.0 (YFAS)

Timeframe: post 16-week intervention

Weight Self-Stigma Questionnaire (WSSQ)

Timeframe: pre 16-week intervention

Weight Self-Stigma Questionnaire (WSSQ)

Timeframe: post 16-week intervention

Patient Health Questionnaire (PHQ-9) with suicide question removed

Timeframe: pre 16-week intervention

Patient Health Questionnaire (PHQ-9) with suicide question removed

Timeframe: post 16-week intervention

Generalized Anxiety Disorder (GAD-7)

Timeframe: pre 16-week intervention