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临床试验/NCT03431831
NCT03431831已完成4 期

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

University of Nebraska2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2017年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
86
试验地点
2
主要终点
Weight

研究概览

简要总结

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).

详细描述

Treatment Assignment:

Both treatment groups,Those who test positive for and those who test negative for FA (food addiction) will be assigned to one of four treatment arms, IC, MI, MI/P and P. All will receive dietary and exercise information.

After consenting, each participant be administered the YFAS to determine their obesity phenotype (positive or negative for FA). Participants within each phenotype will be randomly assigned to one of the intervention (MI or MI+P, or P) or the IC information control (diet and physical activity instruction, which will be no less than current standard of care) treatment groups using a randomization schedule (assignments in numbered, sealed, opaque envelopes; one set for each phenotype) 1:1:1:1 ratio, provided by our statistician, Dr. Struwe. Phenotype assessment and treatment assignment will continue until the sample size (n=10) is met for each phenotype-treatment group category. Those participants in the control group will be seen at the same time periods as each treatment group to maintain their interaction time with the clinic. Participants will receive diet and exercise instruction at each time point.

Intervention Conditions (MI, MI+P):

MI is theorized to decrease a patients ambivalence and increase his/her perceived behavioral control (self-efficacy) for limiting highly processed and high in fat and sugar foods (HPFS) and increasing complex carbohydrates (CC) intake by emphasizing personal choice and control in decision-making and by affirming the patients self-management ability. Interventionist nurses will deliver MI sessions following data collection at baseline,1, 2,3, and 4 weeks and 2, 3, 4, 5, and 6 months to promote sustained behavioral change.50 A written MI algorithm will be used to ensure uniform implementation of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Investigator)

盲法说明

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.

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Intervention Control (Behavioral)

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.

干预措施: Intervention Control (Behavioral)

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.

干预措施: Counselling (Behavioral)

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.

干预措施: Intervention Control (Behavioral)

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.

干预措施: Contrave (Drug)

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.

干预措施: Intervention Control (Behavioral)

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.

干预措施: Counselling (Behavioral)

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.

干预措施: Contrave (Drug)

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.

干预措施: Contrave and Counseling (Drug)

结局指标

主要结局

Weight

时间窗: difference between baseline and 6 months

Weight in lbs

Body Mass Index (BMI)

时间窗: difference between baseline and 6 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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