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临床试验/NCT04337619
NCT04337619已完成不适用

Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss

Drexel University1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2019年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
276
试验地点
1
主要终点
Weight Change

研究概览

简要总结

Mindfulness and Acceptance based Behavioral Therapies (MABTs) are among the most promising behavioral approaches for obesity, with two recent large trials showing that they achieve better initial weight loss and/or better weight loss maintenance than does gold standard behavioral weight loss treatment (BT). However, results vary, potentially due to inconsistencies in how MABT components are utilized and emphasized. Optimizing MABTs using a typical approach, i.e., successive randomized controlled trials of various MABT packages, is slow and difficult. Multiphase Optimization Strategy (MOST) has been developed as a better method of optimizing treatment. Consistent with Phase I of MOST, we derived three MABT components from the theoretical literature. Evaluation of MABT components through a factorial design (MOST Phase II) will allow us to determine the independent and interacting efficacies of each MABT component, in addition to the identification of subsets of individuals most or least responsive to each component. Whereas mediational analyses have been inconclusive, the use of a factorial design will allow for a critical test of the main and interaction effects of individual MABT treatment components. The current study will use a full factorial design to identify the independent and combined effects of three core MABT components (Awareness, Acceptance, and Values Clarity) as additions to remotely delivered weight loss counseling. Moderators of treatment outcome (disinhibited eating, food cue susceptibility, emotional eating, delay discounting, and inhibitory control), and mediator/process variables implicated in MABTs (mindful eating, acceptance of food cues, mindfulness, body responsiveness, autonomous motivation, values clarity, hunger/satiety perceptions, and motivation and pleasure resulting from social functioning) will be assessed as well.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals must be of overweight or obese BMI (27-50 kg/m2)
  • •Individuals must be adults (aged 18-70)
  • •Completion of a 3-day food diary
  • •Completion of baseline assessment tasks
  • •Willingness to lose weight, be physically active, and participate in-group sessions.
  • •Participants must also provide consent for the research team to contact their personal physician if necessary to provide clearance or to consult about rapid weight gain.

排除标准

  • •Inability to engage in physical activity (defined as walking a city block without stopping)
  • •Medical or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the program
  • •Recently began or changed the dose of a medication that can cause significant change in weight
  • •History of bariatric surgery; weight loss of > 5% in the previous 3 months
  • •Currently pregnant or breastfeeding or planning to become pregnant
  • •Planning to, or participating in, another weight loss treatment in the next 3 years.
  • •Engaging in compensatory vomiting, other severe compensatory behaviors, or more than 12 of any compensatory behavior in the previous 3 months
  • •Experiencing significant loss of control eating (9 or more binge episodes in the previous 3 months)

研究组 & 干预措施

Behavioral + Values

Experimental

干预措施: Values (Behavioral)

Behavioral + Mindful Awareness

Experimental

干预措施: Behavioral Treatment (Behavioral)

Behavioral + Willingness + Values + Awareness

Experimental

干预措施: Mindful Awareness (Behavioral)

Behavioral + Values + Awareness

Experimental

干预措施: Behavioral Treatment (Behavioral)

Behavioral + Values + Awareness

Experimental

干预措施: Values (Behavioral)

Behavioral + Values + Awareness

Experimental

干预措施: Mindful Awareness (Behavioral)

Standard Behavioral Weight Loss Treatment

Experimental

干预措施: Behavioral Treatment (Behavioral)

Behavioral + Willingness

Experimental

干预措施: Behavioral Treatment (Behavioral)

Behavioral + Willingness

Experimental

干预措施: Willingness (Behavioral)

Behavioral + Values

Experimental

干预措施: Behavioral Treatment (Behavioral)

Behavioral + Mindful Awareness

Experimental

干预措施: Mindful Awareness (Behavioral)

Behavioral + Willingness + Values

Experimental

干预措施: Behavioral Treatment (Behavioral)

Behavioral + Willingness + Values

Experimental

干预措施: Willingness (Behavioral)

Behavioral + Willingness + Values

Experimental

干预措施: Values (Behavioral)

Behavioral + Willingness + Awareness

Experimental

干预措施: Behavioral Treatment (Behavioral)

Behavioral + Willingness + Awareness

Experimental

干预措施: Willingness (Behavioral)

Behavioral + Willingness + Awareness

Experimental

干预措施: Mindful Awareness (Behavioral)

Behavioral + Willingness + Values + Awareness

Experimental

干预措施: Behavioral Treatment (Behavioral)

Behavioral + Willingness + Values + Awareness

Experimental

干预措施: Willingness (Behavioral)

Behavioral + Willingness + Values + Awareness

Experimental

干预措施: Values (Behavioral)

结局指标

主要结局

Weight Change

时间窗: Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).

Measured at home using a standardized weighing procedure. Participants will be weighed in lightweight clothes without shoes using a standardized bluetooth scale accurate to 0.1 kg.

次要结局

  • Dietary Intake(Measured at baseline, mid-treatment (6 months), post-treatment (12 months) (i.e., at 0, 6, and 12 months).)
  • Physical Activity(Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).)
  • Quality of Life Score(Measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).)

研究者

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

Meghan Butryn

Professor

Drexel University

研究点 (1)

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