Clinical trial NCT04373343: Food Addiction Clinical Treatment Program
Official title: Pilot Investigation of a Novel Therapeutic Intervention for Food Addiction: Food Addiction Clinical Treatment (FACT) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Addiction
Keywords: Obesity Associated Disorder
Binge Eating
Weight, Body
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 2
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Males and females meeting criteria for severe food addiction and interested in completing 16 week pilot treatment
Primary purpose: OTHER

Brief 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

Detailed description: To establish the feasibility of recruiting, enrolling, and treating individuals who meet criteria for FA in a group behavioral intervention for 16 weeks. Data from the current study will be used for the purposes of further exploration of the FACT program in a larger randomized controlled trial. We hypothesize the study will demonstrate the feasibility of evaluating this treatment in future studies

Eligibility criteria: 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)

Primary outcomes:
measure: Yale Food Addiction Scale 2.0 (YFAS)
timeFrame: pre 16-week intervention
measure: Yale Food Addiction Scale 2.0 (YFAS)
timeFrame: post 16-week intervention
measure: Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: pre 16-week intervention
measure: Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: post 16-week intervention
measure: Patient Health Questionnaire (PHQ-9) with suicide question removed
timeFrame: pre 16-week intervention
measure: Patient Health Questionnaire (PHQ-9) with suicide question removed
timeFrame: post 16-week intervention
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: pre 16-week intervention
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: post16-week intervention
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: pre 16-week intervention
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: post 16-week intervention
measure: Cannabis Use Disorder Identification Test (CUDIT)
timeFrame: pre 16-week intervention
measure: Cannabis Use Disorder Identification Test (CUDIT)
timeFrame: post 16-week intervention
measure: Sense of Self-Efficacy Scale
timeFrame: pre 16-week intervention
measure: Sense of Self-Efficacy Scale
timeFrame: post 16-week intervention
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: pre 16-week intervention
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: post 16-week intervention
measure: Physical Fitness Assessment (height)
timeFrame: pre 16-week intervention
measure: Physical Fitness Assessment (weight)
timeFrame: pre 16-week intervention
measure: Physical Fitness Assessment (weight)
timeFrame: post 16-week intervention
measure: Physical Fitness Assessment (body composition)
timeFrame: pre 16-week intervention
measure: Physical Fitness Assessment (body composition)
timeFrame: post 16-week intervention
measure: Resting Metabolic Rate
timeFrame: post 16-week intervention
measure: 4-meter timed walk test
timeFrame: pre 16-week intervention
measure: chair rise test
timeFrame: pre 16-week intervention
measure: chair rise test
timeFrame: post 16-week intervention
measure: Hand use
timeFrame: pre 16-week intervention
measure: Physical Fitness Assessment (height)
timeFrame: post 16-week intervention
measure: Resting Metabolic Rate
timeFrame: pre 16-week intervention
measure: 4-meter timed walk test
timeFrame: post 16-week intervention
measure: Hand use
timeFrame: post 16-week intervention
measure: Hand Dynamometer assessment
timeFrame: pre 16-week intervention
measure: Hand Dynamometer assessment
timeFrame: post 16-week intervention
measure: level of physical activity over the past 7 days
timeFrame: pre 16-week intervention
measure: level of physical activity over the past 7 days
timeFrame: post 16-week intervention
measure: Barratt's Impulsivity Scale (BIS-11), Inhibitory Control subscale
timeFrame: pre 16-week intervention
measure: Urgency, Premeditation, Perseverance, and Sensation Seeking (UPPS) Impulsive Behavior Scale
timeFrame: pre 16-week intervention
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: pre 16-week intervention
measure: Weight Control History
timeFrame: pre 16-week intervention
measure: Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
timeFrame: week 1 post start of study
measure: Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
timeFrame: week 5 post start of study
measure: Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
timeFrame: week 9 post start of study
measure: Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
timeFrame: week 15 post start of study
Secondary outcomes:
measure: Dutch Eating Behavior Questionnaire (DEBQ) Excluding the restraint subscale
timeFrame: pre 16 week intervention
measure: Dutch Eating Behavior Questionnaire (DEBQ) Excluding the restraint subscale
timeFrame: post 16 week intervention
measure: Eating Disorder Examination - Questionnaire Short (EDE-QS)
timeFrame: pre 16 week intervention
measure: Eating Disorder Examination - Questionnaire Short (EDE-QS)
timeFrame: post 16 week intervention
measure: Eating Disorder Diagnostic Scale (EDDS) Restraint Subscale
timeFrame: pre 16 week intervention
measure: Eating Disorder Diagnostic Scale (EDDS) Restraint Subscale
timeFrame: post 16 week intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Shenelle Edwards-Hampton, PhD
role: PRINCIPAL_INVESTIGATOR
References: