Food Addiction Clinical Treatment Program

NCT ID: NCT04373343

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2023-09-07

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

Conditions

Food Addiction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

16-week Food Addiction Clinical Treatment (FACT) Program

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

Group Type: OTHER

16-week Food Addiction Clinical Treatment (FACT) Program

Intervention Type: BEHAVIORAL

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

Interventions

16-week Food Addiction Clinical Treatment (FACT) Program

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

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)

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shenelle Edwards-Hampton, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00053663

Identifier Type: -

Identifier Source: org_study_id