Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income Populations

Inadequate sleep is highly prevalent in low-socioeconomic status (SES) and minority groups
and associated with multiple health problems. The root causes of inadequate sleep are often
related to behavioral practices and stress, both of which may be favorably impacted using
socio-contextually appropriate sleep hygiene recommendations and mind-body practices such as
yoga. A preliminary RCT that will address the role of sleep behavioral interventions in a
high-risk community will be conducted. This evidence is needed to guide mind-body therapies
in low-SES communities in which such strategies are under-utilized to improve health.

The investigators have assembled a multidisciplinary team of experts in sleep medicine,
complementary and integrative health, behavioral medicine, community engagement, social
epidemiology, and clinical trials to conduct a planning study to adapt behavioral sleep
interventions for residents in urban low-income housing and to evaluate their uptake and
fidelity. The investigators have conducted qualitative formative evaluation work and
conducted modified SH and Yoga pilot studies. In this phase, the investigators will deliver a
12-week trial testing the feasibility of (1) an adapted sleep hygiene intervention (SH) and
(2) yoga + adapted sleep hygiene intervention SH+Y):

A. A Sleep Hygiene (SH) Intervention, addressing: beliefs and attitudes towards sleep;
challenges for adhering to sleep hygiene recommendations given chaotic family routines, work
schedules and bedroom conditions; strategies for overcoming barriers, and prioritization of
recommendations most likely to be efficacious.

B. A Yoga (Y) Intervention: intervention intensity/duration and class format; tailored
home-based recommendations for bedtime practice combining meditation, breathing and postures;
tools to assess and enhance adherence; race/ethnicity concordance of the instructor and
student; and use of peer yoga assistants.

The investigators aim to conduct a 40 person 12-week RCT of SH vs SH+Y to inform the design
of a future large-scale RCT. The investigators will evaluate the feasibility of recruiting
from our target community, randomizing individuals to interventions delivered in community
rooms with home-based practices, and delivering the targeted interventions with high
adherence and fidelity. The following will be evaluated:

- Reach of the target population: The number of potentially eligible individuals
approached to participate will be tracked as well as the characteristics of individuals
who do and do not choose to participate, and differences will be assessed. Reasons for
choosing not to participate will be assessed using open ended questions (e.g., burden,
perception of yoga, needs, etc.).

- Adoption and adherence: the proportion of individuals that sustain participation
throughout the intervention will be assessed, and quantify attendance at classes and
home-practices through logs and interim phone interviews. The investigators will
describe patterns of dropout rates and adherence to the interventions by key demographic
factors and by moderating and mediating factors.

- Implementation-consistency of delivery of the intervention: a checklist of core
intervention elements will be used to document the degree to which core elements of the
intervention was delivered as specified in the protocol.

The investigators will also assess the feasibility of collecting a range of baseline,
outcome, process and mediator data and to generate data to support use of specific measures
in a later trial, including patterns of missingness of data, distributions of data,
correlations between outcomes, baseline factors and mediators, and evaluation of
"dose-response" associations between time in intervention and sleep duration and efficiency.

Power analysis (sample size, evaluable subjects, etc.): The study is designed for feasibility
and not powered to test the intervention effect. The SH+Y intervention will be considered as
potentially efficacious if the estimates for the change scores (post-pre within and between
group changes and their 95% confidence intervals) are consistent with clinically significant
improvements in sleep duration (actigraphy sleep increases by > 30 minutes), sleep quality
improves by > 0.3 standard deviations), or sleep hygiene (reduction in deviation in wake time
relative to recommended wake time > 25%). The investigators will consider inclusion of
specific measurements (mediators) in a future RCT based on: <10% missingness; correlation of
change score or baseline score with outcomes of >.20; absence of redundancy with a simpler
metric (r<.80).

Inclusion Criteria:

- Verbally proficient in English

- Self-reported average (over the prior month) weekday sleep duration of < 6 hours

- Reside in a public housing

Exclusion Criteria:

- Severe physical conditions preventing participation in yoga, including major surgery
or head injury in the prior 3 months, or unstable vertebral injury with inability to
sit or lie down for 5 or more minutes; or glaucoma

- Major psychiatric disease (e.g. schizophrenia, depression, PTSD) resulting in
hospitalization in the last year; or disease severity that, in the opinion of the
investigator, would make it difficult for the participant to partake in the study
activities.

- Severe sleep disorders: self-report of physician diagnosed insomnia requiring
hypnotics more than 3 times/ week or an untreated known sleep disorder (sleep apnea,
RLS), that in the opinion of the investigator, would make it difficult for the
participant to achieve sleep hygiene goals.

- Needing an assistive device such as a walker or cane, frequent falls, history of
stroke resulting in weakness or numbness interfering with moving easily, or other
problems causing ongoing balance issues and difficulty walking

- Yoga class participation in last 6 weeks

- Known pregnancy.

- Participation in prior sleep and yoga study pilots