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临床试验/NCT03799289
NCT03799289已完成不适用

Examination of the Feasibility and Preliminary Efficacy of Two Approaches for Improving Long-term Weight Loss

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月3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
60
试验地点
1
主要终点
Program Satisfaction Ratings

研究概览

简要总结

The purpose of this study is to examine two approaches for improving long-term weight loss success. All participants will receive a 12-week, in-person standard behavioral weight loss program followed by either 12 weeks of yoga instruction or 12 weeks of cooking/dietary education instruction (determined via randomization procedures). Assessments of weight, physical activity, dietary behaviors, and psychosocial factors will occur at baseline, 3, and 6 months.

详细描述

Behavioral weight loss (WL) programs result in clinically significant weight losses; however rates of long-term WL maintenance are poor. Previous studies suggest that long-term WL success may require an enhanced ability to overcome physiological and hedonic urges to eat and an improved capacity for dealing with life stressors, negative mood states, and food cravings. Thus interventions which target stress reduction and reduce the tendency to use food as a coping strategy for aversive experiences may offer a protective effect against dietary lapses; thereby improving long-term WL outcomes. Yoga is a mind-body intervention which reduces stress and improves overall physical and psychological well-being and offers promise for strengthening the psychological skill set needed for maintaining important weight-related behaviors long-term. The physical and cognitive skills practiced within yoga target multiple underlying psychological processes (e.g., mindfulness, distress tolerance) which could reduce emotional eating, improve dietary choices, and enhance one's ability to tolerate food cravings or hedonic urges to eat. While yoga is an effective treatment approach for other chronic health conditions, it has not been examined as a potential intervention for improving long-term WL outcomes. Within the context of the obesity field, yoga has been viewed as a mode of exercise and not necessarily as a mind-body intervention approach (as is the case in other fields). Thus, given the lower caloric expenditure of yoga in comparison to many forms of aerobic exercise, the effect of yoga on important weight- related processes and behaviors has not been examined.

The primary aims of this study are to examine the feasibility and acceptability of implementing yoga within a weight management program. Secondary aims focus on examining the impact of yoga, relative to a cooking/dietary education intervention (matched for contact time) on important psychological constructs (perceived stress, mindfulness, and distress tolerance) and weight. Sixty women with overweight or obesity will be randomly assigned to a 12-week standard behavioral WL program, followed by either 12 weeks of group-based yoga or 12 weeks of cooking/dietary information classes. Both groups will be instructed to self-monitor and achieve the dietary and aerobic exercise goals throughout the 24-week program. Primary assessments will occur at baseline and weeks 12 and 24.

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •BMI 25-40 kg/m2

排除标准

  • •Presence of any condition that would limit one's ability to exercise or lose weight safely
  • •Recent weight loss
  • •Current or recent enrollment in a weight loss or mindfulness-based treatment program
  • •Women who are pregnant or planning on becoming pregnant
  • •History of a serious psychiatric disorder
  • •Recent cancer diagnosis (<1 year)
  • •Does not own a smartphone

研究组 & 干预措施

Iyengar Yoga

Experimental

Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.

干预措施: Behavioral weight loss followed by yoga instruction (Behavioral)

Cooking/dietary education

Active Comparator

Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.

干预措施: Behavioral weight loss followed by cooking/dietary education instruction (Behavioral)

结局指标

主要结局

Program Satisfaction Ratings

时间窗: 6 months

Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied)

Intervention Session Attendance

时间窗: 6 months

Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).

Feasibility of the Intervention (Retention)

时间窗: 6 months

Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment

次要结局

  • Changes in Perceived Stress (Measured Via the Perceived Stress Scale)(Change from 12 to 24 weeks)
  • Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale(Change from 12 to 24 weeks)
  • Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale(Change from 12 to 24 weeks)
  • Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale(Change from 12 to 24 weeks)
  • Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale(Change from 12 to 24 weeks)
  • Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale(Change from 12 to 24 weeks)
  • Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)(Change from 12 to 24 weeks)
  • Change in Weight(Change from 12 to 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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