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

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ClinicalTrials.gov Identifier: NCT03431831
Recruitment Status : Active, not recruiting
First Posted : February 13, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Trina Aguirre, University of Nebraska

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).


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Intervention Control Behavioral: Counselling Drug: Contrave Drug: Contrave and Counseling Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Assessment of and Treatment Applied to Food Addiction to Encourage Self-Management of Obesity in a Rural Healthy Behaviors Clinic
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: Intervention Control
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
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.

Experimental: Counselling
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
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.

Experimental: Contrave
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
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.

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.
Other Name: pharmaceutical

Experimental: Contrave and counseling
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
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.
Other Name: pharmaceutical

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.
Other Name: motivational interviewing and pharmaceutical




Primary Outcome Measures :
  1. weight [ Time Frame: difference between baseline and 6 months ]
    lbs

  2. body fat [ Time Frame: difference between baseline and 6 months ]
    lbs



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431831


Locations
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United States, Nebraska
Regional West Medical Center-University of Nebraska Medical Center
Scottsbluff, Nebraska, United States, 69361
Regional West Physicians Clinic
Scottsbluff, Nebraska, United States, 69361
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Trina M Aguirre University of Nebraska
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Trina Aguirre, Assistant Professor, PI., University of Nebraska
ClinicalTrials.gov Identifier: NCT03431831    
Other Study ID Numbers: 763-16
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Obesity
Food Addiction
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Feeding and Eating Disorders
Mental Disorders
Bupropion hydrochloride, naltrexone hydrochoride drug combination
Naltrexone
Bupropion
Anti-Obesity Agents
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors