Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic

NCT03431831 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 0763-16-FB
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

Research purpose: The purpose of this pilot study is to assess obese clients for two phenotypes, those testing positive and those testing negative for Food Addiction (FA) (Yale Food Addiction Scale, YFAS) and determining the efficacy of four treatments: usual care (IC, dietary and physical activity instruction), individual motivational interviewing alone (MI), individual MI with pharmacotherapy (MI+P) for improving outcome measures within each phenotype, and pharmacological therapy (P). Background/significance: Obesity has long been an epidemic in the U.S. and other countries. Numerous approaches have been tried to address obesity with limited success. The YFAS is a relatively new, validated instrument that can help researchers and practitioners assess obese clients for food addiction. Meeting the YFAS diagnosis criteria for FA suggests the need for a stronger intervention with close monitoring to assist these clients in self-management of their eating and physical activity behaviors. Proposed methods/approach: The investigators propose assessing obese clients with the YFAS as part of their intake once they are referred to the Healthy Behaviors Clinic by Regional West physicians/practitioners. A nurse researcher with expertise in MI and a nurse practitioner will perform intake assessments, obtain consent and randomly assign participants in each phenotype (positive or negative for FA) to one of three treatment groups (usual care, individual MI alone, and individual MI with pharmacotherapy). Interventions will occur over 6 months. A clinical psychologist with expertise in the YFAS (University of Michigan) will serve as a consultant on this project and a registered dietitian (University of NebraskaLincoln) will serve as a co-investigator. Expected outcomes: The investigators expect that MI and MI+P and P will be more effective in improving outcome measures than IC. We also expect that response to the treatments will differ between the two obesity phenotypes (those testing positive and those testing negative for FA).

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Weight

  Weight in lbs

  difference between baseline and 6 months

• Body Mass Index (BMI)

  Body Mass Index (BMI): Underweight Below 18.5, Normal 18.5-24.9, Overweight 25.0-29.9, Obesity 30.0 and Above

  difference between baseline and 6 months

Study Arms (4)

Intervention Control

ACTIVE COMPARATOR

All participants will receive diet/physical intervention. One arm will receive diet/physical activity intervention alone as a Intervention/usual care condition.

Behavioral: Intervention Control

Counselling

EXPERIMENTAL

These participants will receive usual care and counseling in the form of motivational interviewing weekly with goal setting for the first 5 weeks and monthly intervention for the final 5 months.

Behavioral: Intervention Control; Behavioral: Counselling

Contrave

EXPERIMENTAL

These participants will receive usual care and prescription of Contrave for weight loss. They will be seen weekly for the first 5 weeks and monthly for the final 5 months.

Behavioral: Intervention Control; Drug: Contrave

Contrave and counseling

EXPERIMENTAL

These participants will receive usual care of diet and physical activity recommendations and Contrave prescription and counseling (motivational interviewing interventions weekly for the first 5 weeks and then monthly for 5 months.

Behavioral: Intervention Control; Behavioral: Counselling; Drug: Contrave; Drug: Contrave and Counseling

Interventions

Intervention Control BEHAVIORAL

diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages.

Contrave; Contrave and counseling; Counselling; Intervention Control

Counselling BEHAVIORAL

Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating.

Contrave and counseling; Counselling

Contrave DRUG

In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly.

Also known as: pharmaceutical

Contrave; Contrave and counseling

Contrave and Counseling DRUG

This group of participants will receive a combination of all the above interventions including diet/physical activity prescription, motivational interviewing and Contrave.

Also known as: motivational interviewing and pharmaceutical

Contrave and counseling

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight/Obese Adult patients (age 19 years -65)
• eligible based on WALI screening tool

You may not qualify if:

• Inability to understand and read English.
• Women pregnant or lactating.
• persons with terminal illness

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

Regional West Medical Center-University of Nebraska Medical Center

Scottsbluff, Nebraska, 69361, United States

Location

Regional West Physicians Clinic

Scottsbluff, Nebraska, 69361, United States

Location

Related Publications (1)

• Koehler A, Aguirre T, Schulte E, Bowman R, Struwe L. Secondary analysis of YFAS 2.0 symptom counts, impairment/distress, and food addiction severity in adults with overweight/obesity. Eat Weight Disord. 2021 Oct;26(7):2393-2399. doi: 10.1007/s40519-020-01077-1. Epub 2021 Jan 3.

  PMID: 33389719 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Counseling; bupropion hydrochloride, naltrexone hydrochoride drug combination; Pharmaceutical Preparations; Motivational Interviewing

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Directive Counseling

Results Point of Contact

• Title: Trina Aguirre
• Organization: University of Nebraska Medical Center

taguirre@unmc.edu

308-632-0410

Study Officials

• Trina M Aguirre

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Statistician will make random assignment envelopes, clerical staff will collect intake forms and make envelope assignments according to randomization schedule. Participants will see different providers based on trial arm assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 13, 2018
• Study Start: July 1, 2017
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)