Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income Populations
Condition: Sleep
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility of conducting a future randomized
      control trial that will compare the efficacy of sleep behavioral interventions in a high-risk
      community including adapted sleep hygiene and yoga. The investigators will conduct a 40
      person 12-week randomized control trial (RCT) in low-income housing population where half the
      participants will receive a community adapted sleep hygiene intervention (SH) and half will
      receive a community adapted sleep hygiene intervention and a yoga intervention. 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.
    

Detailed description: 
      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).
    

Intervention name(s): Sleep hygiene intervention; Yoga intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal.; Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral interventions; Sleep hygiene; Yoga; Community research; Short sleep duration; Low-income population