Back to resultsFood Addiction Clinical Treatment Program (FACT)
Primary Purpose
Food Addiction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
16-week Food Addiction Clinical Treatment (FACT) Program
Sponsored by
About this trial
This is an interventional other trial for Food Addiction focused on measuring Obesity Associated Disorder, Binge Eating, Weight, Body
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)
Sites / Locations
- Wake Forest Health Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
16-week Food Addiction Clinical Treatment (FACT) Program
Arm Description
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
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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)
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)
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.
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.
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
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
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.
Physical Fitness Assessment (weight)
Weight will be measured using the TANITA scale.
Physical Fitness Assessment (weight)
Weight will be measured using the TANITA scale.
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.
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.
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
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
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.
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.
Hand use
An administrator capture whether or not the subject used their hands. (yes/no).
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.
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
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
Hand use
An administrator capture whether or not the subject used their hands. (yes/no).
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.
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.
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.
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.
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
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.
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
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.
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.
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.
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.
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.
Secondary Outcome Measures
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
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
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
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
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)
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)
Full Information
NCT ID
NCT04373343
First Posted
April 21, 2020
Last Updated
September 29, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04373343
Brief Title
Food Addiction Clinical Treatment Program
Acronym
FACT
Official Title
Pilot Investigation of a Novel Therapeutic Intervention for Food Addiction: Food Addiction Clinical Treatment (FACT) Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
September 7, 2023 (Actual)
Study Completion Date
September 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Addiction
Keywords
Obesity Associated Disorder, Binge Eating, Weight, Body
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Males and females meeting criteria for severe food addiction and interested in completing 16 week pilot treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
16-week Food Addiction Clinical Treatment (FACT) Program
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
16-week Food Addiction Clinical Treatment (FACT) Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Yale Food Addiction Scale 2.0 (YFAS)
Description
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
Time Frame
pre 16-week intervention
Title
Yale Food Addiction Scale 2.0 (YFAS)
Description
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
Time Frame
post 16-week intervention
Title
Weight Self-Stigma Questionnaire (WSSQ)
Description
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
Time Frame
pre 16-week intervention
Title
Weight Self-Stigma Questionnaire (WSSQ)
Description
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
Time Frame
post 16-week intervention
Title
Patient Health Questionnaire (PHQ-9) with suicide question removed
Description
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
Time Frame
pre 16-week intervention
Title
Patient Health Questionnaire (PHQ-9) with suicide question removed
Description
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
Time Frame
post 16-week intervention
Title
Generalized Anxiety Disorder (GAD-7)
Description
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
Time Frame
pre 16-week intervention
Title
Generalized Anxiety Disorder (GAD-7)
Description
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
Time Frame
post16-week intervention
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
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
Time Frame
pre 16-week intervention
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
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
Time Frame
post 16-week intervention
Title
Cannabis Use Disorder Identification Test (CUDIT)
Description
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)
Time Frame
pre 16-week intervention
Title
Cannabis Use Disorder Identification Test (CUDIT)
Description
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)
Time Frame
post 16-week intervention
Title
Sense of Self-Efficacy Scale
Description
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.
Time Frame
pre 16-week intervention
Title
Sense of Self-Efficacy Scale
Description
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.
Time Frame
post 16-week intervention
Title
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Description
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
Time Frame
pre 16-week intervention
Title
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Description
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
Time Frame
post 16-week intervention
Title
Physical Fitness Assessment (height)
Description
subject's height will be taken using a wall-mounted stadiometer and weight will be taken using a medical-grade scale.
Time Frame
pre 16-week intervention
Title
Physical Fitness Assessment (weight)
Description
Weight will be measured using the TANITA scale.
Time Frame
pre 16-week intervention
Title
Physical Fitness Assessment (weight)
Description
Weight will be measured using the TANITA scale.
Time Frame
post 16-week intervention
Title
Physical Fitness Assessment (body composition)
Description
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.
Time Frame
pre 16-week intervention
Title
Physical Fitness Assessment (body composition)
Description
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.
Time Frame
post 16-week intervention
Title
Resting Metabolic Rate
Description
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
Time Frame
post 16-week intervention
Title
4-meter timed walk test
Description
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
Time Frame
pre 16-week intervention
Title
chair rise test
Description
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.
Time Frame
pre 16-week intervention
Title
chair rise test
Description
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.
Time Frame
post 16-week intervention
Title
Hand use
Description
An administrator capture whether or not the subject used their hands. (yes/no).
Time Frame
pre 16-week intervention
Title
Physical Fitness Assessment (height)
Description
subject's height will be taken using a wall-mounted stadiometer and weight will be taken using a medical-grade scale.
Time Frame
post 16-week intervention
Title
Resting Metabolic Rate
Description
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
Time Frame
pre 16-week intervention
Title
4-meter timed walk test
Description
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
Time Frame
post 16-week intervention
Title
Hand use
Description
An administrator capture whether or not the subject used their hands. (yes/no).
Time Frame
post 16-week intervention
Title
Hand Dynamometer assessment
Description
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.
Time Frame
pre 16-week intervention
Title
Hand Dynamometer assessment
Description
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.
Time Frame
post 16-week intervention
Title
level of physical activity over the past 7 days
Description
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.
Time Frame
pre 16-week intervention
Title
level of physical activity over the past 7 days
Description
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.
Time Frame
post 16-week intervention
Title
Barratt's Impulsivity Scale (BIS-11), Inhibitory Control subscale
Description
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
Time Frame
pre 16-week intervention
Title
Urgency, Premeditation, Perseverance, and Sensation Seeking (UPPS) Impulsive Behavior Scale
Description
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.
Time Frame
pre 16-week intervention
Title
Posttraumatic Stress Disorder Checklist (PCL-5)
Description
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
Time Frame
pre 16-week intervention
Title
Weight Control History
Description
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.
Time Frame
pre 16-week intervention
Title
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Description
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.
Time Frame
week 1 post start of study
Title
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Description
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.
Time Frame
week 5 post start of study
Title
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Description
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.
Time Frame
week 9 post start of study
Title
Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)
Description
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.
Time Frame
week 15 post start of study
Secondary Outcome Measure Information:
Title
Dutch Eating Behavior Questionnaire (DEBQ) Excluding the restraint subscale
Description
The 33 question's scale ranges from 1 (never) to 5 (very often).with higher scores indicating greater endorsement of the eating behavior
Time Frame
pre 16 week intervention
Title
Dutch Eating Behavior Questionnaire (DEBQ) Excluding the restraint subscale
Description
The 33 question's scale ranges from 1 (never) to 5 (very often).with higher scores indicating greater endorsement of the eating behavior
Time Frame
post 16 week intervention
Title
Eating Disorder Examination - Questionnaire Short (EDE-QS)
Description
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
Time Frame
pre 16 week intervention
Title
Eating Disorder Examination - Questionnaire Short (EDE-QS)
Description
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
Time Frame
post 16 week intervention
Title
Eating Disorder Diagnostic Scale (EDDS) Restraint Subscale
Description
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)
Time Frame
pre 16 week intervention
Title
Eating Disorder Diagnostic Scale (EDDS) Restraint Subscale
Description
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)
Time Frame
post 16 week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shenelle Edwards-Hampton, PhD
Organizational Affiliation
Wake Forest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Food Addiction Clinical Treatment Program
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