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Clinical Trials/NCT03799289
NCT03799289
Completed
Not Applicable

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

The Miriam Hospital1 site in 1 country60 target enrollmentJanuary 3, 2019
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
The Miriam Hospital
Enrollment
60
Locations
1
Primary Endpoint
Program Satisfaction Ratings
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
December 29, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • BMI 25-40 kg/m2

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Program Satisfaction Ratings

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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