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临床试验/NCT03991676
NCT03991676已完成不适用

Clarifying the Role of Values in Weight Control: A Pilot Study of a Values-Based Intervention to Promote Weight Loss

Drexel University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年4月29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
19
试验地点
1
主要终点
Participant acceptability and satisfaction with the intervention

研究概览

简要总结

More than 160 million American adults are overweight or obese. Existing weight loss interventions from self-help to gold standard behavioral treatments, while often effective, do not sufficiently maintain motivation to adhere to dietary goals in the face of powerful biological and environmental influences to consume highly palatable foods. Clarification and awareness of values, a staple of acceptance-based treatments drawn from Acceptance and Commitment Therapy, are thought to enhance autonomous motivation to engage in behaviors consistent with one's personal life values (e.g., health) in the presence of countervailing forces (e.g., hunger, deprivation). However, the independent efficacy of values clarification and awareness in facilitating weight control has never been tested. This pilot study seeks to investigate the feasibility and acceptability of a series of three weight loss workshops (based off the gold standard) infused with values clarification and awareness techniques to promote weight control. Participants will be asked to follow a reduced-calorie dietary prescription while holding their values in mind in moments of dietary decision-making over the course of one month. The primary aims of this study are to: 1) develop the series of values-infused workshops, using participant feedback to iterate and improve the treatment manual; and 2) evaluate treatment acceptability. Secondary aims are: 1) to evaluate whether clinically meaningful changes in measures of values clarification and values awareness occur; 2) to evaluate whether the intervention will lead participants to experience clinically meaningful changes in values-congruent weight control behaviors; 3) to evaluate whether the intervention will lead participants to experience clinically meaningful changes in weight; and 4) to evaluate theorized mechanisms of action in the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • •BMI of 25-55 kg/m2
  • •18-70 years of age
  • •Have a desire to lose weight
  • •Own a smartphone
  • •Live in the Philadelphia area
  • •Provide informed consent

排除标准

  • •Any medical or psychiatric conditions (e.g., eating disorder, diabetes) that may pose a risk to the participant during the intervention, cause a change in weight or appetite, or interfere with ability to adhere to diet recommendations
  • •Recent change in medication dosage that could affect weight or appetite
  • •Current or planned pregnancy in the next month
  • •Planned move out of the Philadelphia area in the next month
  • •History of bariatric surgery
  • •Weight loss of ≥5% in the last six months
  • •Concurrent behavioral therapy targeting weight control

研究组 & 干预措施

Values-Based Behavioral Treatment

Experimental

干预措施: Values-Based Behavioral Treatment (Behavioral)

结局指标

主要结局

Participant acceptability and satisfaction with the intervention

时间窗: Measured at post-treatment (1 month).

Participant acceptability and satisfaction with the intervention will be assessed using an idiosyncratic self-report Acceptability Questionnaire, developed for the present study. Questions include items assessing how satisfied participants were with the intervention, how helpful they found it, and how likely they would be to recommend it to others. Scores range from 1 to 5 for each item, where higher values represent greater satisfaction and acceptability.

次要结局

  • Values clarity(Measured at baseline and post-treatment (1 month) assessments.)
  • Values awareness(Measured at baseline and post-treatment (1 month) assessments.)
  • Values-congruent weight control behavior(Measured at baseline and post-treatment (1 month) assessments.)
  • Weight(Measured at baseline, 1 week, 2 weeks, 3 weeks, and post-treatment (1 month) assessment.)
  • Autonomous motivation(Measured at baseline and post-treatment (1 month) assessments.)

研究者

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

Diane Dallal

Graduate Student

Drexel University

研究点 (1)

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