Clinical trial

Assessment of and Treatment Applied to Food Addiction to Encourage Self-Management of Obesity in a Rural Healthy Behaviors Clinic

Name

0763-16-FB

Description

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).

Trial arms

Trial start

2017-07-01

Estimated PCD

2022-06-01

Trial end

2022-07-01

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Contrave, Contrave and counseling, Counselling, Intervention Control

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.

Arms:

Contrave and counseling, Counselling

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.

Arms:

Contrave, Contrave and counseling

Other names:

pharmaceutical

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.

Arms:

Contrave and counseling

Other names:

motivational interviewing and pharmaceutical

Size

Primary endpoint

weight

difference between baseline and 6 months

body fat

difference between baseline and 6 months

Eligibility criteria

Inclusion Criteria: * Overweight/Obese Adult patients (age 19 years -65) * eligible based on WALI screening tool Exclusion Criteria: * Inability to understand and read English. * Women pregnant or lactating. * persons with terminal illness

Protocol

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Updated at

2023-07-19

1 organization

1 product

1 indication

Organization

University of Nebraska

Product

Contrave

Indication

Obesity