Food AddictionFACTNCT04373343
Food Addiction Clinical Treatment Program
A study testing 16-week Food Addiction Clinical Treatment (FACT) Program in people with Food Addiction, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Food Addiction
- What is being tested?
- 16-week Food Addiction Clinical Treatment (FACT) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 7 Sep 2023
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Pilot Investigation of a Novel Therapeutic Intervention for Food Addiction: Food Addiction Clinical Treatment (FACT) Program
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
Read the 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
- Conditions
- Food Addiction
- Being tested
- 16-week Food Addiction Clinical Treatment (FACT) Program
- Keywords
- Obesity Associated Disorder, Binge Eating, Weight, Body
- Medical subject headings
- Food Addiction, Bulimia, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16-week Food Addiction Clinical Treatment (FACT) ProgramBehavioural
16-week Food Addiction Clinical Treatment (FACT) Program, first session will be 120 mins, all subsequent sessions will be 90 mins. Treatment will be led, at a minimum, by a full licensed psychologist
| Study group | Role | What they receive |
|---|---|---|
| 16-week Food Addiction Clinical Treatment (FACT) Program | Other | 16-week Food Addiction Clinical Treatment (FACT) Program, first session will be 120 mins, all subsequent sessions will be 90 mins. Treatment will be led, at a minimum, by a full licensed psychologist Receives: Behavioral: 16-week Food Addiction Clinical Treatment (FACT) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Food Addiction Scale 2.0 (YFAS)
The YFAS 2.0 is a self-report measure used to assess addictive eating behaviors related to highly processed foods. The YFAS 2.0 consists of 35 items based on the DSM - 5 diagnostic criteria for substance use No Food Addiction = 0-1 symptoms/score Mild Food Addiction = 2 or 3 score Moderate Food Addiction = 4 or 5 score Severe Food Addiction = 6 or higher score
Measured: pre 16-week intervention
Yale Food Addiction Scale 2.0 (YFAS)
The YFAS 2.0 is a self-report measure used to assess addictive eating behaviors related to highly processed foods. The YFAS 2.0 consists of 35 items based on the DSM - 5 diagnostic criteria for substance use No Food Addiction = 0-1 symptoms/score Mild Food Addiction = 2 or 3 score Moderate Food Addiction = 4 or 5 score Severe Food Addiction = 6 or higher score
Measured: post 16-week intervention
Weight Self-Stigma Questionnaire (WSSQ)
WSSQ assesses two aspects of internalized weight stigma: self-devaluation and fear of enacted stigma. It contains 12 items rated on a 5-point Likert scale - Higher scores mean that you experience more shame related to your weight or body shape, while lower scores indicate that you experience less
Measured: pre 16-week intervention
Weight Self-Stigma Questionnaire (WSSQ)
WSSQ assesses two aspects of internalized weight stigma: self-devaluation and fear of enacted stigma. It contains 12 items rated on a 5-point Likert scale - Higher scores mean that you experience more shame related to your weight or body shape, while lower scores indicate that you experience less
Measured: post 16-week intervention
Patient Health Questionnaire (PHQ-9) with suicide question removed
a self-report measure consisting of 9 questions, each aligning with one of the DSM - IV criteria for depression. The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20 item self-report measure that assesses the DSM-5 symptoms of PTSD and is a commonly used tool to screen subjects for PTSD 0-4 Minimal or no depression 5-9 Mild depression 10-14 Moderate 15-19 Moderately severe > 20 Severe
Measured: pre 16-week intervention
Patient Health Questionnaire (PHQ-9) with suicide question removed
a self-report measure consisting of 9 questions, each aligning with one of the DSM - IV criteria for depression. The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20 item self-report measure that assesses the DSM-5 symptoms of PTSD and is a commonly used tool to screen subjects for PTSD 0-4 Minimal or no depression 5-9 Mild depression 10-14 Moderate 15-19 Moderately severe > 20 Severe
Measured: post 16-week intervention
Generalized Anxiety Disorder (GAD-7)
brief self-report assessment of anxiety. The measure consists of 7 items that quickly identify anxiety symptoms and severity - Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively
Measured: pre 16-week intervention
Generalized Anxiety Disorder (GAD-7)
brief self-report assessment of anxiety. The measure consists of 7 items that quickly identify anxiety symptoms and severity - Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively
Measured: post16-week intervention
Alcohol Use Disorder Identification Test (AUDIT)
a self-report measure assessing alcohol consumption, drinking behaviors, and alcohol-related problems. The 10-item scale is used as a screening tool - A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence
Measured: pre 16-week intervention
Alcohol Use Disorder Identification Test (AUDIT)
a self-report measure assessing alcohol consumption, drinking behaviors, and alcohol-related problems. The 10-item scale is used as a screening tool - A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence
Measured: post 16-week intervention
Cannabis Use Disorder Identification Test (CUDIT)
a self-report 8 item measure assessing various cannabis use behaviors - Scores can range from 1 to 32, with a cut-off score of 13 indicative of a DSM-IV diagnosis of CUD (dependence)
Measured: pre 16-week intervention
Cannabis Use Disorder Identification Test (CUDIT)
a self-report 8 item measure assessing various cannabis use behaviors - Scores can range from 1 to 32, with a cut-off score of 13 indicative of a DSM-IV diagnosis of CUD (dependence)
Measured: post 16-week intervention
Sense of Self-Efficacy Scale
a questionnaire that measures a participant's level of belief in his or her ability to take the necessary actions to accomplish a goal. It consists of 20 items that assess self-efficacy in the areas of decision-making, coping and social skills, and planning - The scale has a range of scores from 0-90. A higher number on the score represents a higher self-efficacy for exercise.
Measured: pre 16-week intervention
Sense of Self-Efficacy Scale
a questionnaire that measures a participant's level of belief in his or her ability to take the necessary actions to accomplish a goal. It consists of 20 items that assess self-efficacy in the areas of decision-making, coping and social skills, and planning - The scale has a range of scores from 0-90. A higher number on the score represents a higher self-efficacy for exercise.
Measured: post 16-week intervention
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
is a self-report questionnaire assessing the individual's perceptions in the context of their culture and value systems, and their personal goals, standards, and concerns. It consists of 26 items measuring physical health, psychological health, social relationships, and environment - higher scores denote higher quality of life
Measured: pre 16-week intervention
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
is a self-report questionnaire assessing the individual's perceptions in the context of their culture and value systems, and their personal goals, standards, and concerns. It consists of 26 items measuring physical health, psychological health, social relationships, and environment - higher scores denote higher quality of life
Measured: post 16-week intervention
Physical Fitness Assessment (height)
subject's height will be taken using a wall-mounted stadiometer and weight will be taken using a medical-grade scale.
Measured: pre 16-week intervention
Physical Fitness Assessment (weight)
Weight will be measured using the TANITA scale.
Measured: pre 16-week intervention
Physical Fitness Assessment (weight)
Weight will be measured using the TANITA scale.
Measured: post 16-week intervention
Physical Fitness Assessment (body composition)
body composition will be measured using the TANITA scale. This measure provides information about a subject's body fat percentage, body water weight percentage, and lean muscle mass percentage.
Measured: pre 16-week intervention
Physical Fitness Assessment (body composition)
body composition will be measured using the TANITA scale. This measure provides information about a subject's body fat percentage, body water weight percentage, and lean muscle mass percentage.
Measured: post 16-week intervention
Resting Metabolic Rate
Resting Metabolic Rate (RMR) will be measured using the CardioCoach or ReeVue (KORR Medical Technologies, Salt Lake City, UT). An RMR measurement uses oxygen consumed at rest to determine a person's caloric requirements for weight loss or maintenance
Measured: post 16-week intervention
4-meter timed walk test
The 4-meter timed walk test will be used to measure normal gait speed and provide an approximate measure of physical functioning and level of deconditioning. The subject will be instructed to walk at their normal pace through a hallway that has a 4-meter distance marked with tape on the floor
Measured: pre 16-week intervention
chair rise test
The chair rise test is completed on a standard chair and provides information related to lower limb strength and agility. Subjects will be asked to stand up and sit down 5 times as fast as they can. Differences can be used descriptively but no definitive conclusions related to changes in fitness level can or will be made.
Measured: pre 16-week intervention
chair rise test
The chair rise test is completed on a standard chair and provides information related to lower limb strength and agility. Subjects will be asked to stand up and sit down 5 times as fast as they can. Differences can be used descriptively but no definitive conclusions related to changes in fitness level can or will be made.
Measured: post 16-week intervention
Hand use
An administrator capture whether or not the subject used their hands. (yes/no).
Measured: pre 16-week intervention
Physical Fitness Assessment (height)
subject's height will be taken using a wall-mounted stadiometer and weight will be taken using a medical-grade scale.
Measured: post 16-week intervention
Resting Metabolic Rate
Resting Metabolic Rate (RMR) will be measured using the CardioCoach or ReeVue (KORR Medical Technologies, Salt Lake City, UT). An RMR measurement uses oxygen consumed at rest to determine a person's caloric requirements for weight loss or maintenance
Measured: pre 16-week intervention
4-meter timed walk test
The 4-meter timed walk test will be used to measure normal gait speed and provide an approximate measure of physical functioning and level of deconditioning. The subject will be instructed to walk at their normal pace through a hallway that has a 4-meter distance marked with tape on the floor
Measured: post 16-week intervention
Hand use
An administrator capture whether or not the subject used their hands. (yes/no).
Measured: post 16-week intervention
Hand Dynamometer assessment
provides a measure of upper body strength. The subject will be asked to squeeze as hard as he/she can and then relax. The average score of the three trials will be compared to the data norms. A dynamometer provides objective grip strength data. Males normally can generate about 46 kg of force, and females about 23 kg.
Measured: pre 16-week intervention
Hand Dynamometer assessment
provides a measure of upper body strength. The subject will be asked to squeeze as hard as he/she can and then relax. The average score of the three trials will be compared to the data norms. A dynamometer provides objective grip strength data. Males normally can generate about 46 kg of force, and females about 23 kg.
Measured: post 16-week intervention
level of physical activity over the past 7 days
Participants will also be asked 11 questions related to the frequency and amount of time spent in vigorous physical activity, moderate physical activity, walking, and sitting over the past 7 days.
Measured: pre 16-week intervention
level of physical activity over the past 7 days
Participants will also be asked 11 questions related to the frequency and amount of time spent in vigorous physical activity, moderate physical activity, walking, and sitting over the past 7 days.
Measured: post 16-week intervention
Barratt's Impulsivity Scale (BIS-11), Inhibitory Control subscale
a self-report questionnaire assessing the personality trait of impulsiveness. The scale includes 30 items covering attention, motor, and non-planning impulsiveness; only the Inhibitory Control subscale will be used for the purpose of this study - on a scale of "1" to "4": 1) rarely/never, 2) occasionally, 3) often, and 4) almost always/always
Measured: pre 16-week intervention
Urgency, Premeditation, Perseverance, and Sensation Seeking (UPPS) Impulsive Behavior Scale
a self-report questionnaire assessing the personality trait of impulsiveness. The 45-item scale measures premediation, urgency, sensation-seeking, and perseverance; only the urgency subscale will be used for the purpose of the study - The Scale is not considered a measure of trait impulsivity, rather, the scales reflect distinct personality traits that lead to impulsive-type behavior. Participants are asked to consider acts/incidents during the last 6 months when rating their behavior and attitudes on a 4-point scale, in which 1-Agree strongly, 2-Agree some, 3-Disagree some, 4-Disagree strongly.The UPPS-P Negative Urgency scale (this is the only subscale on the UPPS we will be using) is a 12-item Likert-type scale to measure one's tendency to act rashly in response to intense negative mood states. It is a continuous scale, with higher scores meaning more negative urgency.
Measured: pre 16-week intervention
Posttraumatic Stress Disorder Checklist (PCL-5)
is a 20 item self-report measure that assesses the DSM-5 symptoms of PTSD and is a commonly used tool to screen subjects for PTSD. Subjects rate each item from 1 ("not at all") to 5 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month.0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely Tally up score, total possible score range is 0-80. Score of >31 is considered significant for possible PTSD, <31 is considered non-significant for possible PTSD
Measured: pre 16-week intervention
Weight Control History
Participants will also be asked questions related to their history of attempting to control their weight, including their weight at age 18, weight approximately 1 year ago, whether or not they have attempted to lose weight in the past year, and information related to their past 3 attempts at weight loss. Gathering this data for descriptive purposes, there is no "outcome," form of scoring, or analysis that will take place with this information.
Measured: pre 16-week intervention
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
an abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (YFAS 2.0). The mYFAS 2.0 has one question to assess each of the 11 DSM-5 diagnostic criteria for substance-use disorders, plus 2 questions to assess clinically significant distress and impairment. The modified versions of the YFAS perform similarly on psychometric indicators as the full versions of the scale and are useful brief assessment tool for food addiction.
Measured: week 1 post start of study
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
an abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (YFAS 2.0). The mYFAS 2.0 has one question to assess each of the 11 DSM-5 diagnostic criteria for substance-use disorders, plus 2 questions to assess clinically significant distress and impairment. The modified versions of the YFAS perform similarly on psychometric indicators as the full versions of the scale and are useful brief assessment tool for food addiction.
Measured: week 5 post start of study
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
an abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (YFAS 2.0). The mYFAS 2.0 has one question to assess each of the 11 DSM-5 diagnostic criteria for substance-use disorders, plus 2 questions to assess clinically significant distress and impairment. The modified versions of the YFAS perform similarly on psychometric indicators as the full versions of the scale and are useful brief assessment tool for food addiction.
Measured: week 9 post start of study
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
an abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (YFAS 2.0). The mYFAS 2.0 has one question to assess each of the 11 DSM-5 diagnostic criteria for substance-use disorders, plus 2 questions to assess clinically significant distress and impairment. The modified versions of the YFAS perform similarly on psychometric indicators as the full versions of the scale and are useful brief assessment tool for food addiction.
Measured: week 15 post start of study
Secondary outcomes (6)
Dutch Eating Behavior Questionnaire (DEBQ) Excluding the restraint subscale
The 33 question's scale ranges from 1 (never) to 5 (very often).with higher scores indicating greater endorsement of the eating behavior
Measured: pre 16 week intervention
Dutch Eating Behavior Questionnaire (DEBQ) Excluding the restraint subscale
The 33 question's scale ranges from 1 (never) to 5 (very often).with higher scores indicating greater endorsement of the eating behavior
Measured: post 16 week intervention
Eating Disorder Examination - Questionnaire Short (EDE-QS)
self-report measure assessing maladaptive eating behaviors. The questionnaire consists of 12 questions about eating behaviors in order to assess disordered eating behaviors - Scores on each item range from "0" to "6", with higher scores indicating higher symptom levels with higher scores indicating greater endorsement of the eating behavior
Measured: pre 16 week intervention
Eating Disorder Examination - Questionnaire Short (EDE-QS)
self-report measure assessing maladaptive eating behaviors. The questionnaire consists of 12 questions about eating behaviors in order to assess disordered eating behaviors - Scores on each item range from "0" to "6", with higher scores indicating higher symptom levels with higher scores indicating greater endorsement of the eating behavior
Measured: post 16 week intervention
Eating Disorder Diagnostic Scale (EDDS) Restraint Subscale
self-report measure assessing maladaptive eating behaviors consisting of 22 questions related to anorexia nervosa, bulimia nervosa, and binge-eating disorder - seven-point scale, ranging from 0 (not at all) to 6 (extremely)
Measured: pre 16 week intervention
Eating Disorder Diagnostic Scale (EDDS) Restraint Subscale
self-report measure assessing maladaptive eating behaviors consisting of 22 questions related to anorexia nervosa, bulimia nervosa, and binge-eating disorder - seven-point scale, ranging from 0 (not at all) to 6 (extremely)
Measured: post 16 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start21 Mar 2023
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Males and females meeting criteria for severe food addiction and interested in completing 16 week pilot treatment
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shenelle Edwards-Hampton, PhD, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373343
- Sponsor's protocol ID
- IRB00053663
- Acronym
- FACT
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of a Novel Therapeutic Intervention for Food Addiction: Food Addiction Clinical Treatment (FACT) Program
- ClinicalTrials.gov ID
- NCT04373343
- Acronym / sponsor ID
- FACT / IRB00053663
- Conditions
- Food Addiction
- Keywords
- Obesity Associated Disorder, Binge Eating, Weight, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 4 May 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 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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Males and females meeting criteria for severe food addiction and interested in completing 16 week pilot treatment
| Arm | Type | Receives |
|---|---|---|
| 16-week Food Addiction Clinical Treatment (FACT) Program | Other | Behavioral: 16-week Food Addiction Clinical Treatment (FACT) Program16-week Food Addiction Clinical Treatment (FACT) Program, first session will be 120 mins, all subsequent sessions will be 90 mins. Treatment will be led, at a minimum, by a full licensed psychologist |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| 16-week Food Addiction Clinical Treatment (FACT) Program16-week Food Addiction Clinical Treatment (FACT) Program, first session will be 120 mins, all subsequent sessions will be 90 mins. Treatment will be led, at a minimum, by a full licensed psychologist | Behavioural | 16-week Food Addiction Clinical Treatment (FACT) Program |
Primary outcome
Yale Food Addiction Scale 2.0 (YFAS)
Time frame: pre 16-week intervention
The YFAS 2.0 is a self-report measure used to assess addictive eating behaviors related to highly processed foods. The YFAS 2.0 consists of 35 items based on the DSM - 5 diagnostic criteria for substance use No Food Addiction = 0-1 symptoms/score Mild Food Addiction = 2 or 3 score Moderate Food Addiction = 4 or 5 score Severe Food Addiction = 6 or higher score
Yale Food Addiction Scale 2.0 (YFAS)
Time frame: post 16-week intervention
The YFAS 2.0 is a self-report measure used to assess addictive eating behaviors related to highly processed foods. The YFAS 2.0 consists of 35 items based on the DSM - 5 diagnostic criteria for substance use No Food Addiction = 0-1 symptoms/score Mild Food Addiction = 2 or 3 score Moderate Food Addiction = 4 or 5 score Severe Food Addiction = 6 or higher score
Weight Self-Stigma Questionnaire (WSSQ)
Time frame: pre 16-week intervention
WSSQ assesses two aspects of internalized weight stigma: self-devaluation and fear of enacted stigma. It contains 12 items rated on a 5-point Likert scale - Higher scores mean that you experience more shame related to your weight or body shape, while lower scores indicate that you experience less
Weight Self-Stigma Questionnaire (WSSQ)
Time frame: post 16-week intervention
WSSQ assesses two aspects of internalized weight stigma: self-devaluation and fear of enacted stigma. It contains 12 items rated on a 5-point Likert scale - Higher scores mean that you experience more shame related to your weight or body shape, while lower scores indicate that you experience less
Patient Health Questionnaire (PHQ-9) with suicide question removed
Time frame: pre 16-week intervention
a self-report measure consisting of 9 questions, each aligning with one of the DSM - IV criteria for depression. The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20 item self-report measure that assesses the DSM-5 symptoms of PTSD and is a commonly used tool to screen subjects for PTSD 0-4 Minimal or no depression 5-9 Mild depression 10-14 Moderate 15-19 Moderately severe > 20 Severe
Patient Health Questionnaire (PHQ-9) with suicide question removed
Time frame: post 16-week intervention
a self-report measure consisting of 9 questions, each aligning with one of the DSM - IV criteria for depression. The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20 item self-report measure that assesses the DSM-5 symptoms of PTSD and is a commonly used tool to screen subjects for PTSD 0-4 Minimal or no depression 5-9 Mild depression 10-14 Moderate 15-19 Moderately severe > 20 Severe
Generalized Anxiety Disorder (GAD-7)
Time frame: pre 16-week intervention
brief self-report assessment of anxiety. The measure consists of 7 items that quickly identify anxiety symptoms and severity - Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively
Generalized Anxiety Disorder (GAD-7)
Time frame: post16-week intervention
brief self-report assessment of anxiety. The measure consists of 7 items that quickly identify anxiety symptoms and severity - Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: pre 16-week intervention
a self-report measure assessing alcohol consumption, drinking behaviors, and alcohol-related problems. The 10-item scale is used as a screening tool - A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: post 16-week intervention
a self-report measure assessing alcohol consumption, drinking behaviors, and alcohol-related problems. The 10-item scale is used as a screening tool - A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence
Cannabis Use Disorder Identification Test (CUDIT)
Time frame: pre 16-week intervention
a self-report 8 item measure assessing various cannabis use behaviors - Scores can range from 1 to 32, with a cut-off score of 13 indicative of a DSM-IV diagnosis of CUD (dependence)
Cannabis Use Disorder Identification Test (CUDIT)
Time frame: post 16-week intervention
a self-report 8 item measure assessing various cannabis use behaviors - Scores can range from 1 to 32, with a cut-off score of 13 indicative of a DSM-IV diagnosis of CUD (dependence)
Sense of Self-Efficacy Scale
Time frame: pre 16-week intervention
a questionnaire that measures a participant's level of belief in his or her ability to take the necessary actions to accomplish a goal. It consists of 20 items that assess self-efficacy in the areas of decision-making, coping and social skills, and planning - The scale has a range of scores from 0-90. A higher number on the score represents a higher self-efficacy for exercise.
Sense of Self-Efficacy Scale
Time frame: post 16-week intervention
a questionnaire that measures a participant's level of belief in his or her ability to take the necessary actions to accomplish a goal. It consists of 20 items that assess self-efficacy in the areas of decision-making, coping and social skills, and planning - The scale has a range of scores from 0-90. A higher number on the score represents a higher self-efficacy for exercise.
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: pre 16-week intervention
is a self-report questionnaire assessing the individual's perceptions in the context of their culture and value systems, and their personal goals, standards, and concerns. It consists of 26 items measuring physical health, psychological health, social relationships, and environment - higher scores denote higher quality of life
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: post 16-week intervention
is a self-report questionnaire assessing the individual's perceptions in the context of their culture and value systems, and their personal goals, standards, and concerns. It consists of 26 items measuring physical health, psychological health, social relationships, and environment - higher scores denote higher quality of life
Physical Fitness Assessment (height)
Time frame: pre 16-week intervention
subject's height will be taken using a wall-mounted stadiometer and weight will be taken using a medical-grade scale.
Physical Fitness Assessment (weight)
Time frame: pre 16-week intervention
Weight will be measured using the TANITA scale.
Physical Fitness Assessment (weight)
Time frame: post 16-week intervention
Weight will be measured using the TANITA scale.
Physical Fitness Assessment (body composition)
Time frame: pre 16-week intervention
body composition will be measured using the TANITA scale. This measure provides information about a subject's body fat percentage, body water weight percentage, and lean muscle mass percentage.
Physical Fitness Assessment (body composition)
Time frame: post 16-week intervention
body composition will be measured using the TANITA scale. This measure provides information about a subject's body fat percentage, body water weight percentage, and lean muscle mass percentage.
Resting Metabolic Rate
Time frame: post 16-week intervention
Resting Metabolic Rate (RMR) will be measured using the CardioCoach or ReeVue (KORR Medical Technologies, Salt Lake City, UT). An RMR measurement uses oxygen consumed at rest to determine a person's caloric requirements for weight loss or maintenance
4-meter timed walk test
Time frame: pre 16-week intervention
The 4-meter timed walk test will be used to measure normal gait speed and provide an approximate measure of physical functioning and level of deconditioning. The subject will be instructed to walk at their normal pace through a hallway that has a 4-meter distance marked with tape on the floor
chair rise test
Time frame: pre 16-week intervention
The chair rise test is completed on a standard chair and provides information related to lower limb strength and agility. Subjects will be asked to stand up and sit down 5 times as fast as they can. Differences can be used descriptively but no definitive conclusions related to changes in fitness level can or will be made.
chair rise test
Time frame: post 16-week intervention
The chair rise test is completed on a standard chair and provides information related to lower limb strength and agility. Subjects will be asked to stand up and sit down 5 times as fast as they can. Differences can be used descriptively but no definitive conclusions related to changes in fitness level can or will be made.
Hand use
Time frame: pre 16-week intervention
An administrator capture whether or not the subject used their hands. (yes/no).
Physical Fitness Assessment (height)
Time frame: post 16-week intervention
subject's height will be taken using a wall-mounted stadiometer and weight will be taken using a medical-grade scale.
Resting Metabolic Rate
Time frame: pre 16-week intervention
Resting Metabolic Rate (RMR) will be measured using the CardioCoach or ReeVue (KORR Medical Technologies, Salt Lake City, UT). An RMR measurement uses oxygen consumed at rest to determine a person's caloric requirements for weight loss or maintenance
4-meter timed walk test
Time frame: post 16-week intervention
The 4-meter timed walk test will be used to measure normal gait speed and provide an approximate measure of physical functioning and level of deconditioning. The subject will be instructed to walk at their normal pace through a hallway that has a 4-meter distance marked with tape on the floor
Hand use
Time frame: post 16-week intervention
An administrator capture whether or not the subject used their hands. (yes/no).
Hand Dynamometer assessment
Time frame: pre 16-week intervention
provides a measure of upper body strength. The subject will be asked to squeeze as hard as he/she can and then relax. The average score of the three trials will be compared to the data norms. A dynamometer provides objective grip strength data. Males normally can generate about 46 kg of force, and females about 23 kg.
Hand Dynamometer assessment
Time frame: post 16-week intervention
provides a measure of upper body strength. The subject will be asked to squeeze as hard as he/she can and then relax. The average score of the three trials will be compared to the data norms. A dynamometer provides objective grip strength data. Males normally can generate about 46 kg of force, and females about 23 kg.
level of physical activity over the past 7 days
Time frame: pre 16-week intervention
Participants will also be asked 11 questions related to the frequency and amount of time spent in vigorous physical activity, moderate physical activity, walking, and sitting over the past 7 days.
level of physical activity over the past 7 days
Time frame: post 16-week intervention
Participants will also be asked 11 questions related to the frequency and amount of time spent in vigorous physical activity, moderate physical activity, walking, and sitting over the past 7 days.
Barratt's Impulsivity Scale (BIS-11), Inhibitory Control subscale
Time frame: pre 16-week intervention
a self-report questionnaire assessing the personality trait of impulsiveness. The scale includes 30 items covering attention, motor, and non-planning impulsiveness; only the Inhibitory Control subscale will be used for the purpose of this study - on a scale of "1" to "4": 1) rarely/never, 2) occasionally, 3) often, and 4) almost always/always
Urgency, Premeditation, Perseverance, and Sensation Seeking (UPPS) Impulsive Behavior Scale
Time frame: pre 16-week intervention
a self-report questionnaire assessing the personality trait of impulsiveness. The 45-item scale measures premediation, urgency, sensation-seeking, and perseverance; only the urgency subscale will be used for the purpose of the study - The Scale is not considered a measure of trait impulsivity, rather, the scales reflect distinct personality traits that lead to impulsive-type behavior. Participants are asked to consider acts/incidents during the last 6 months when rating their behavior and attitudes on a 4-point scale, in which 1-Agree strongly, 2-Agree some, 3-Disagree some, 4-Disagree strongly.The UPPS-P Negative Urgency scale (this is the only subscale on the UPPS we will be using) is a 12-item Likert-type scale to measure one's tendency to act rashly in response to intense negative mood states. It is a continuous scale, with higher scores meaning more negative urgency.
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: pre 16-week intervention
is a 20 item self-report measure that assesses the DSM-5 symptoms of PTSD and is a commonly used tool to screen subjects for PTSD. Subjects rate each item from 1 ("not at all") to 5 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month.0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely Tally up score, total possible score range is 0-80. Score of >31 is considered significant for possible PTSD, <31 is considered non-significant for possible PTSD
Weight Control History
Time frame: pre 16-week intervention
Participants will also be asked questions related to their history of attempting to control their weight, including their weight at age 18, weight approximately 1 year ago, whether or not they have attempted to lose weight in the past year, and information related to their past 3 attempts at weight loss. Gathering this data for descriptive purposes, there is no "outcome," form of scoring, or analysis that will take place with this information.
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Time frame: week 1 post start of study
an abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (YFAS 2.0). The mYFAS 2.0 has one question to assess each of the 11 DSM-5 diagnostic criteria for substance-use disorders, plus 2 questions to assess clinically significant distress and impairment. The modified versions of the YFAS perform similarly on psychometric indicators as the full versions of the scale and are useful brief assessment tool for food addiction.
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Time frame: week 5 post start of study
an abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (YFAS 2.0). The mYFAS 2.0 has one question to assess each of the 11 DSM-5 diagnostic criteria for substance-use disorders, plus 2 questions to assess clinically significant distress and impairment. The modified versions of the YFAS perform similarly on psychometric indicators as the full versions of the scale and are useful brief assessment tool for food addiction.
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Time frame: week 9 post start of study
an abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (YFAS 2.0). The mYFAS 2.0 has one question to assess each of the 11 DSM-5 diagnostic criteria for substance-use disorders, plus 2 questions to assess clinically significant distress and impairment. The modified versions of the YFAS perform similarly on psychometric indicators as the full versions of the scale and are useful brief assessment tool for food addiction.
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Time frame: week 15 post start of study
an abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (YFAS 2.0). The mYFAS 2.0 has one question to assess each of the 11 DSM-5 diagnostic criteria for substance-use disorders, plus 2 questions to assess clinically significant distress and impairment. The modified versions of the YFAS perform similarly on psychometric indicators as the full versions of the scale and are useful brief assessment tool for food addiction.
6 secondary outcomes
Dutch Eating Behavior Questionnaire (DEBQ) Excluding the restraint subscale
Time frame: pre 16 week intervention
Dutch Eating Behavior Questionnaire (DEBQ) Excluding the restraint subscale
Time frame: post 16 week intervention
Eating Disorder Examination - Questionnaire Short (EDE-QS)
Time frame: pre 16 week intervention
Eating Disorder Examination - Questionnaire Short (EDE-QS)
Time frame: post 16 week intervention
Eating Disorder Diagnostic Scale (EDDS) Restraint Subscale
Time frame: pre 16 week intervention
Eating Disorder Diagnostic Scale (EDDS) Restraint Subscale
Time frame: post 16 week intervention
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 7 Nov 2023.
- Individual participant dataSharing planned: Yes
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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.
Shenelle Edwards-Hampton, PhD principal investigator
Wake Forest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16-week Food Addiction Clinical Treatment (FACT) Program in people with Food Addiction, run by Wake Forest University Health Sciences 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 10 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 7 Nov 2023. 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?
Yale Food Addiction Scale 2.0 (YFAS) (time frame: pre 16-week intervention). The study lists 42 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 7 Nov 2023.