Integration of Yoga for the Treatment of Obesity in Adults
Condition: Obesity; Physical Activity; Weight Loss; Weight Change, Body
MeSH terms: Obesity; Body Weight; Weight Loss; Body Weight Changes
Study type: Interventional

Summary: 
      The focus of this study is to examine the feasibility of integrating Vinyasa yoga into a
      Standard Behavioral Weight Loss Intervention, to examine whether engagement differs between
      Vinyasa yoga and a restorative form of Hatha yoga within a Standard Behavioral Weight Loss
      Intervention, and to use this information to inform an expanded study to directly test the
      effectiveness of these interventions on weight loss in adults.
    

Detailed description: 
      The focus of this study is to examine the feasibility of integrating Vinyasa yoga into a
      Standard Behavioral Weight Loss Intervention, to examine whether engagement differs between
      Vinyasa yoga and a restorative form of Hatha yoga within a Standard Behavioral Weight Loss
      Intervention, and to use this information to inform an expanded study to directly test the
      effectiveness of these interventions on weight loss in adults. Thus, study will pursing the
      following aims:

        -  Vinyasa yoga will be integrated into the Standard Behavioral Weight Loss Intervention.
           This will require refinement of the Vinyasa yoga intervention to assure that this is
           appropriate for adults with obesity and to develop the necessary Vinyasa yoga
           intervention materials.

        -  The feasibility of randomizing and retaining participants within the context of a
           Standard Behavioral Weight Loss Intervention that also includes either a restorative
           Hatha style of yoga or Vinyasa style of yoga will be examined.

        -  The fidelity and compliance to the yoga components of the intervention will be examined.

      To examine the aims listed above potential participants will be recruited through a variety
      of advertisement methods. Those individuals responding to these advertisements will have the
      study explained to them and informed consent will be obtained. These participants will
      complete a series of screening assessments that will be used to determine eligibility (height
      and weight to determine body mass index, resting blood pressure, heart rate,
      cardiorespiratory fitness). For participants deemed to be eligible and randomized to
      participate in this study, these measures will also be used as their baseline data from
      analysis. Additional data collection will be collected at the baseline assessment visit, with
      assessments repeated following the 6 month intervention. Assessments will include the
      following:

        -  Height and Weight

        -  Resting Blood Pressure and Heart Rate

        -  Cardiorespiratory Fitness

        -  Anthropometric Measures (girth of waist and hips)

        -  Physical Activity

        -  Dietary Intake

        -  Additional Questionnaires to assess demographics, physical activity barriers, eating
           behaviors, sedentary behavior, physical activity self-efficacy, mindfulness,
           psychological flexibility and self-regulation, affect, perceived stress, anxiety, sleep,
           depressive symptoms, and treatment satisfaction.

      Assessments will be completed at both baseline and following the 6-month intervention.
      Moreover, following the intervention, participants will engage in group-based qualitative
      interviews. These qualitative interviews will focus on better understanding strengths,
      weaknesses, and barriers to engagement in the intervention that was used in this study. This
      information will be used to refine our approach prior to pursuing additional studies in this
      areas of research.

      This study involves a 6 month behavioral weight loss intervention (SBWI) with participants
      randomized to either Hatha Yoga or Vinyasa Yoga as the form of physical activity. All
      randomized participant will received the components of the SBWI along with either Hatha Yoga
      or Vinyasa Yoga based on their randomized intervention assignment. Participants will attend
      weekly group meetings for all weeks of the study. Group meetings will last approximately
      30-45 minutes in duration and will be led by trained behavioral interventionists with
      previous experience facilitating behavioral weight loss intervention meetings. These meetings
      will focus on strategies to promote behavior change and weight management. Strategies to
      promote behavior change will included the Social Cognitive Theory, Problem Solving Theory,
      and Relapse Prevention. Participants will be weighed weekly prior to group meetings to track
      changes in weight throughout the study and assist interventionists with weight counseling.
      Participants who do not attend the weekly group meeting will be contacted via telephone call
      to reschedule for an individual weigh-in and make-up session with an interventionist prior to
      the next group meeting. If an individual make-up session cannot be scheduled, an
      interventionist will provide a brief counseling session by telephone and the written
      materials will be mailed to the participant.

      Dietary recommendations within the intervention will be based on the participants' baseline
      body weight. These calorie goals are based on intake recommendations that have been
      successful in other weight loss programs, and fat intake goals are consistent with the USDA
      Dietary Guidelines. Participants weighing less than 200 pounds will be prescribed a 1200
      kcal/day diet, participants weighing between 200 to less than 250 will be prescribed 1500
      kcal/day, and participants weighing 250 or more will be prescribed 1800 kcal/day. To promote
      adoption and adherence to these recommendations, participants will be provided
      self-monitoring paper diaries, meal plans, and sample recipes. Participants will be
      instructed to self-monitor daily and will be instructed to turn in self-monitoring food
      diaries to their interventionist prior to group intervention meetings. Printed intervention
      lessons will also include information related to behavior strategies for achieving the
      recommended calorie and fat intake goals.

      Physical Activity Components of the Intervention:

      Hatha Yoga Group: The specific description of physical activity for those randomized to
      receive Hatha Yoga will focus on a restorative style of Hatha yoga. This will involve a
      systematic progression to allow for participants to acclimate to the poses and this style of
      yoga practice. Total duration will begin at 100 minutes per week and will gradually progress
      in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60
      minutes per day). Participants will be instructed to spread this dose of activity equally
      across 5 days each week, with each session starting at 20 minutes and progressing to 50
      minutes. The initial 1-2 weeks will focus on the participants understanding the asanas (or
      poses) and gaining kinesthetic awareness of their body while moving through the movement
      sequences. Study participants will be provided with a yoga mat to use throughout the study,
      and they will be permitted to keep this yoga mat at the conclusion of their participation in
      this study.

      While attending the SBWI group session the participants will also engage in a supervised yoga
      session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised
      yoga, yoga videos that we develop that mimic the asanas (poses) and flow patterns that are
      taught in the supervised yoga sessions will be provided, and these videos will be led by the
      same individual who is instructing the supervised yoga sessions. To facilitate the use of
      these yoga videos by participants, access will be provided by loading them on to a tablet
      (iPad, Surface, etc.) that will be provided to the participant or through other electronic
      formats (YouTube Channel, streaming through study website, etc.). The sequence of videos will
      be scheduled to be accessible to the participant on predetermined dates that coincide with
      the progression of the yoga activities in the intervention.

      Vinyasa Yoga Group: The specific description of physical activity for those randomized to
      receive Vinyasa Yoga will focus on a more vigorous form of yoga. This will involve a
      systematic progression to allow for participants to acclimate to the poses and this style of
      yoga practice. Total duration will begin at 100 minutes per week and will gradually progress
      in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60
      minutes per day). Participants will be instructed to spread this dose of activity equally
      across 5 days each week, with each session starting at 20 minutes and progressing to 50
      minutes. The initial 1-2 weeks will focus on the participants understanding the asanas (or
      poses) and gaining kinesthetic awareness of their body while moving through the movement
      sequences. Study participants will be provided with a yoga mat to use throughout the study,
      and they will be permitted to keep this yoga mat at the conclusion of their participation in
      this study.

      While attending the SBWI group session the participants will also engage in a supervised yoga
      session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised
      yoga, yoga videos that we develop that mimic the asanas (poses) and flow patterns that are
      taught in the supervised yoga sessions will be provided, and these videos will be led by the
      same individual who is instructing the supervised yoga sessions. To facilitate the use of
      these yoga videos by participants, access will be provided by loading them on to a tablet
      (iPad, Surface, etc.) that will be provided to the participant or through other electronic
      formats (YouTube Channel, streaming through study website, etc.). The sequence of videos will
      be scheduled to be accessible to the participant on predetermined dates that coincide with
      the progression of the yoga activities in the intervention.
    

Intervention name(s): Hatha Yoga Intervention; Vinyasa Yoga Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Hatha Yoga will focus on a restorative style of Hatha yoga. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). While attending the behavioral group sessions the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, we will provide yoga videos that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions. The intervention includes prescribed dietary recommendations based on the participants' baseline body weight, and self-monitoring diaries, meal plans, and sample recipes will be provided. Intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals. Participants will also be provided weekly group intervention sessions across the study period.; Vinyasa Yoga will focus on a more vigorous form of yoga. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). While attending the behavioral group sessions the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, we will provide yoga videos that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions. The intervention includes prescribed dietary recommendations based on the participants' baseline body weight, and self-monitoring diaries, meal plans, and sample recipes will be provided. Intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals. Participants will also be provided weekly group intervention sessions across the study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of two intervention conditions, with assessments occurring at pre-intervention and post-intervention.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; yoga; mindfulness; weight loss; physical activity