Clinical trial NCT03799289: Approaches for Improving Long-term Weight Loss
Official title: Examination of the Feasibility and Preliminary Efficacy of Two Approaches for Improving Long-term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
physical activity
yoga
exercise
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-01-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* BMI 25-40 kg/m2
* Female

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

Primary outcomes:
measure: Program Satisfaction Ratings
timeFrame: 6 months
measure: Intervention Session Attendance
timeFrame: 6 months
measure: Feasibility of the Intervention (Retention)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Perceived Stress (Measured Via the Perceived Stress Scale)
timeFrame: Change from 12 to 24 weeks
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale
timeFrame: Change from 12 to 24 weeks
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale
timeFrame: Change from 12 to 24 weeks
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale
timeFrame: Change from 12 to 24 weeks
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale
timeFrame: Change from 12 to 24 weeks
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale
timeFrame: Change from 12 to 24 weeks
measure: Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)
timeFrame: Change from 12 to 24 weeks
measure: Change in Weight
timeFrame: Change from 12 to 24 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital's Weight Control & Diabetes Research Center
name: Jessica Unick, PhD
role: PRINCIPAL_INVESTIGATOR
References: