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临床试验/NCT02198196
NCT02198196已完成不适用

Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs

Consumer Wellness Solutions2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
Eating Inventory - Internal Disinhibition subscale

研究概览

简要总结

The purpose of this study is to explore the efficacy of a phone-based weight loss program that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The program is targeted at employees of certain companies who meet a cut-off score on a measure of stress-related eating. The control group will receive a standard phone-based program with no additional stress management information (Weight Talk-Standard).

  • Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience decreases in their stress-related & emotion-related eating compared to the Weight Talk-Standard (WT-S; n=25) group.
  • Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.
  • Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased eating self-efficacy, increased acceptance of weight-related thoughts & feelings and increased mindfulness compared to those in the WT-S control arm.
  • Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss program as those in WT-S.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • Be enrolled in the Weight Talk program, inclusion criteria:
  • Employment by one of the employers who contract for Weight Talk services
  • Being over 18 years of age
  • Speak and read English
  • Have a starting BMI between 25 and
  • Score 5 or higher on the 8-item Internal Disinhibition subscale of the Eating Inventory.
  • Have regular access to email and internet.
  • Willingness and ability to complete study and intervention procedures, including completing assessments, engaging in moderate physical activity (e.g., walking, swimming) and using the electronic scale at least once per week.

排除标准

  • Type 2 Diabetes (Type 1 is an exclusion for the Weight Talk program).
  • Past diagnosis of anorexia nervosa or bulimia nervosa.
  • Weight Talk program exclusion criteria include:
  • Pregnancy
  • Bariatric surgery within past 12 months or planned in the next 6 months
  • Undergoing dialysis
  • Have Type 1 Diabetes diagnosis
  • Women who are pregnant are not eligible for the program, but contraception is not required as this is a low risk study
  • Currently using or planning to start using a pharmaceutical weight loss drug

结局指标

主要结局

Eating Inventory - Internal Disinhibition subscale

时间窗: Screening and 6-month follow-up

8 items, screens for emotion and stress-related eating habits

次要结局

  • Body weight(Screening and 6-month follow-up)

研究者

发起方
Consumer Wellness Solutions
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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