Integration of Yoga for the Treatment of Obesity in Adults

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.

Inclusion Criteria:

- Both males and females of all race/ethnic groups are eligible for participation in
this study.

- 18-60 years of age.

- Body mass index (BMI) between 25.0 to <40.0 kg/m2.

- Ability to provide informed consent prior to participation in this study.

- Ability to provide clearance from their primary care physician to engage in the diet
and physical activity components of the weight loss intervention.

Exclusion Criteria:

- Report moderate-to-vigorous exercise on >3 days per week or a total of >60 minutes per
week over the past 3 months.

- Engaging in any style of yoga on an average of at least 1 day per week over the past 3
months.

- Report weight loss of >3% or participating in a weight reduction diet in the past 3
months.

- Females who are pregnant or breastfeeding, or reporting a planned pregnancy during the
study period.

- History of bariatric surgery.

- Report current medical condition or treatment for a medical condition that could
affect body weight. These may include the following: diabetes mellitus;
hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency;
chronic liver disease; cancer; gastrointestinal disorders including ulcerative
colitis, Crohn's disease, or malabsorption syndromes; etc.

- Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative
of an increased acute risk for a cardiovascular event, prior myocardial infarction,
coronary artery bypass grafting or angioplasty, conditions requiring chronic
anticoagulation (i.e. recent or recurrent DVT).

- Resting systolic blood pressure of >160 mmHg or resting diastolic blood pressure of
>100 mmHg.

- Eating disorders that would contraindicate weight loss or physical activity.

- Alcohol or substance abuse.

- Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.),
taking psychotropic medications within the previous 12 months, or hospitalized for
depression within the previous 5 years.

- Report plans to relocate to a location not accessible to the study site or having
employment, personal, or travel commitments that prohibit attendance at scheduled
intervention sessions or assessments.

- Physical activity or weight loss deemed to be contraindicated based on response to the
cardiorespiratory fitness test that will be conducted as part of the screening
procedures.