跳至主要内容
临床试验/NCT04666831
NCT04666831已完成不适用

Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction: A Randomized Controlled Trial

Toronto Metropolitan University2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
Consumption of Highly Processed Foods

研究概览

简要总结

Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and the engineering of food products. Although food addiction is not a recognized mental disorder, individuals do identify as being addicted to foods and self-help organizations have existed since 1960 to purportedly treat it (i.e., through abstinence). However, little research has been conducted on how abstinence approaches work. Such methods may even be harmful given the risk of disordered eating. Currently, there are no empirically supported treatments for food addiction. However, evidence-based treatments do exist for addictions and eating disorders, such as motivational interviewing and cognitive behavioural therapy, which may prove beneficial for food addiction, given neural similarities between addictions and binge eating.

The current study proposes a randomized controlled trial using a four-session adapted motivational interviewing (AMI) and cognitive behavioural therapy (CBT) intervention for food addiction. This intervention combines the personalized assessment feedback and person-centred counseling of AMI with CBT skills for eating disorders, such as self-monitoring of food intake. The aim is to motivate participants to enact behavioural change, such as reduced and moderate consumption of processed foods. Outcome measures will assess food addiction and binge eating symptoms, self-reported consumption of processed foods, readiness for change, eating self-efficacy, and other constructs such as emotional eating. The intervention condition will be compared to a waitlist control group. Both groups will be assessed at pre- and postintervention periods, as well as over a 3-month follow-up period to assess maintenance effects. Based on a power analysis and previous effect sizes following AMI interventions for binge eating, a total sample size of n = 58 is needed. A total of 131 individuals will be recruited to account for previous exclusion and withdrawal rates. Participation is estimated to take place from March 2021 to March 2022. All intervention sessions will be conducted virtually over secure videoconferencing technology or telephone, expanding access to all adult community members across Ontario, Canada. Twenty randomly selected session tapes will be reviewed for MI adherence.

详细描述

Background: Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and engineering of food products in industrialized countries. Food addiction is assessed using the validated Yale Food Addiction Scale (YFAS), which applies substance use disorder criteria from the most recent Diagnostic and Statistical Manual of Mental Disorders to the consumption of these types of foods. Prevalence estimates of food addiction range from 8-15% in two nationally representative samples in the U.S. and Germany. Although food addiction is not a currently recognized mental disorder, individuals do identify as being addicted to foods and self-help organizations such as Overeaters Anonymous have existed since 1960 to purportedly treat it (i.e., through abstinence). However, little research has been conducted on how abstinence approaches work and such methods may even be harmful for individuals with eating concerns, given the risk of disordered eating. Currently, there are no empirically supported treatments for food addiction. However, evidence-based treatments do exist for addictions and eating disorders, such as Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT), which may prove beneficial for food addiction, given neural similarities between substance addiction and binge eating, and the potential for high ambivalence. AMI is designed to allow clients to voice their own motivations for change and the use of AMI skills by therapists has been shown in meta-analyses to predict this type of change talk, which then predicts positive behavioural outcomes, Given that food addiction is also associated with internalized weight bias and lower eating self-efficacy, AMI techniques in fostering acceptance, highlighting client strengths, and providing psychoeducation may help to lower self-blame and bolster confidence to change one's eating habits.

Method: The current study proposes a randomized controlled trial using a four-session AMI and CBT intervention for food addiction. Due to COVID-19 limitations, all intervention sessions will be conducted virtually over secure videoconferencing technology or by telephone, expanding access to all adult community members across the province of Ontario in Canada. The intervention combines the personalized assessment feedback and person-centred counselling of AMI with CBT skills for eating disorders, such as self-monitoring of food intake and stimulus control. The aim is to motivate participants to enact behavioural change, such as moderate consumption of processed foods in a harm reduction approach. Twenty randomly selected session tapes will be reviewed by two trained coders to assess for MI adherence using the most commonly used MI fidelity measure. The intervention condition will be compared to a wait-list control (WLC) group. Both groups will be assessed at pre- and postintervention periods, as well as over a 3-month follow-up period to assess maintenance effects.

Hypotheses

Primary Hypotheses - Food Addiction and Binge Eating Frequency (H1-H3)

  • H1: Compared to WLC, AMI will lead to a significantly greater reduction in food addiction symptoms (using the YFAS 2.0) at postintervention and up to 3 months postintervention.
  • H2: Compared to WLC, AMI will lead to a significantly greater reduction in self-reported consumption of highly processed foods specified in the YFAS 2.0 (using the Canadian Diet History Questionnaire II) at postintervention and up to 3 months postintervention.
  • H3: Compared to WLC, AMI will lead a to significantly greater reduction in number of binge eating episodes (using select Eating Disorder Examination Questionnaire questions) at postintervention and up to 3 months postintervention.

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
None

盲法说明

Since this study uses a behavioural intervention (psychotherapy), neither the participant nor the care provider can be blinded. Outcomes are assessed using online questionnaires.

入排标准

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

入选标准

  • Meets criteria on the modified Yale Food Addiction Scale 2.0 for at least "Mild Food Addiction" (2 symptoms of food addiction and clinical significance)
  • Fluent in English
  • 18 years or older
  • Have access to e-mail
  • Have access to high speed internet and Zoom OR telephone
  • Have private space to conduct remote therapy sessions
  • Must live in the province of Ontario, Canada

排除标准

  • Current active suicidality or recent psychiatric hospitalizations in the past 6 months

结局指标

主要结局

Consumption of Highly Processed Foods

时间窗: Change from baseline to 3 months postintervention

Measured by the Canadian Diet History Questionnaire II. Minimum score = 0. There is no maximum score, as this measures caloric consumption. Higher values mean worse outcome.

Binge Eating Frequency

时间窗: Change from baseline to 3 months postintervention

Measured by select Eating Disorder Examination Questionnaire 6.0 questions. Minimum score = 0. There is no maximum as this measures binge eating frequency. Higher values mean worse outcome.

Food Addiction Symptoms

时间窗: Change from baseline to 3 months postintervention

Measured by the Yale Food Addiction Scale 2.0. Minimum score = 0 symptoms, Maximum score = 11 symptoms. Greater symptoms mean worse outcome.

次要结局

  • Eating Self-Efficacy (confidence to resist the desire to eat in various situations) as assessed by the Weight Efficacy Lifestyle Questionnaire(Change from baseline and immediately postintervention)
  • Binge Eating Symptoms(Change from baseline to 3 months postintervention)
  • General Appetite for Palatable Foods or Hedonic Hunger(Change from baseline to 3 months postintervention)
  • Cravings for Specific Highly Processed Foods(Change from baseline to 3 months postintervention)
  • Body Mass Index(Change from baseline to 3 months postintervention)
  • Working Alliance(During the intervention (change from session 1 to session 4))
  • Motivation to Change Eating(Change from baseline and immediately postintervention)
  • Emotional Eating(Change from baseline to 3 months postintervention)
  • Weight Bias Internalization(Change from baseline and immediately postintervention)
  • Self-Identified Food Addiction(Change from baseline to 3 months postintervention)
  • Addiction-like Eating Behaviour(Change from baseline to 3 months postintervention)
  • Loss of Control Eating(Change from baseline to 3 months postintervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vincent Santiago, MA

Principal Investigator

Toronto Metropolitan University

研究点 (2)

Loading locations...

相似试验