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

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

Interventions

BEHAVIORAL

Intervention Control

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.

BEHAVIORAL

Counselling

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.

DRUG

Contrave

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.

DRUG

Contrave and Counseling

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

Sponsors & Collaborators

• University of Nebraska

  lead OTHER

Principal Investigators

• Trina M Aguirre · University of Nebraska

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2022-06-01

Completion

2022-07-01

FDA Drug

Yes

Countries

• United States

Study Locations