Trial Outcomes & Findings for Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income Populations (NCT NCT03392194)
NCT ID: NCT03392194
Last Updated: 2019-09-11
Results Overview
Change in sleep duration from baseline to follow-up measure by actigraphs. We will conduct a repeated measures ANCOVA, modeling time, intervention group and a time\*intervention interaction. We will explore change in stress, anxiety, depressive symptoms, mindfulness, and sleep hygiene score as potential explanatory variables.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-09-11
Participant Flow
From January-March 2018, participants were recruited from two affordable housing communities. Convenience and snowball sampling methods were employed. Study staff and community partners provided information to interested participants at community events and distributed flyers and postcards throughout the communities.
Sleep hygiene (SH) group sessions served as a run-in period for randomization. Participants were consented to participate in the research study (n=38) and then attended two SH group session. At the end of the second SH session, participants were randomized to the SH-arm or the sleep hygiene and yoga (SH+Y) arm (n=33).
Participant milestones
| Measure |
Sleep Hygiene & Yoga (SH+Y)
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).
Sleep hygiene intervention: 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.
Yoga intervention: 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).
|
Sleep Hygiene (SH)
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.
Sleep hygiene intervention: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Sleep Hygiene & Yoga (SH+Y)
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).
Sleep hygiene intervention: 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.
Yoga intervention: 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).
|
Sleep Hygiene (SH)
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.
Sleep hygiene intervention: 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Conflicts with personal schedule
|
1
|
0
|
Baseline Characteristics
The number analyzed in rows differs from overall due to missing count (not all participants were compliant or successful in wearing actigraphy)
Baseline characteristics by cohort
| Measure |
Sleep Hygiene & Yoga (SH+Y)
n=16 Participants
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).
Sleep hygiene intervention: 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.
Yoga intervention: 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).
|
Sleep Hygiene (SH)
n=17 Participants
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.
Sleep hygiene intervention: 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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=16 Participants
|
15 Participants
n=17 Participants
|
29 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=16 Participants
|
2 Participants
n=17 Participants
|
4 Participants
n=33 Participants
|
|
Age, Continuous
|
44.44 years
STANDARD_DEVIATION 14.74 • n=16 Participants
|
47.29 years
STANDARD_DEVIATION 10.83 • n=17 Participants
|
45.91 years
STANDARD_DEVIATION 13.09 • n=33 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=16 Participants
|
15 Participants
n=17 Participants
|
30 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=16 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=16 Participants
|
7 Participants
n=17 Participants
|
13 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=16 Participants
|
9 Participants
n=17 Participants
|
19 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=33 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=16 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=16 Participants
|
8 Participants
n=17 Participants
|
14 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=16 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=16 Participants
|
3 Participants
n=17 Participants
|
5 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=16 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=33 Participants
|
|
Sleep Duration
|
400.69 minutes/night
STANDARD_DEVIATION 75.45 • n=15 Participants • The number analyzed in rows differs from overall due to missing count (not all participants were compliant or successful in wearing actigraphy)
|
418.06 minutes/night
STANDARD_DEVIATION 66.07 • n=15 Participants • The number analyzed in rows differs from overall due to missing count (not all participants were compliant or successful in wearing actigraphy)
|
409.37 minutes/night
STANDARD_DEVIATION 70.24 • n=30 Participants • The number analyzed in rows differs from overall due to missing count (not all participants were compliant or successful in wearing actigraphy)
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The missing count is based on 21 participants having adequate quality actigraphy data at both baseline and endpoint
Change in sleep duration from baseline to follow-up measure by actigraphs. We will conduct a repeated measures ANCOVA, modeling time, intervention group and a time\*intervention interaction. We will explore change in stress, anxiety, depressive symptoms, mindfulness, and sleep hygiene score as potential explanatory variables.
Outcome measures
| Measure |
Sleep Hygiene & Yoga (SH+Y)
n=11 Participants
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).
Sleep hygiene intervention: 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.
Yoga intervention: 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).
|
Sleep Hygiene (SH)
n=14 Participants
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.
Sleep hygiene intervention: 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.
|
|---|---|---|
|
Sleep Duration
|
-0.91 minutes/night
Standard Deviation 43.87
|
-2.93 minutes/night
Standard Deviation 66.92
|
Adverse Events
Sleep Hygiene & Yoga (SH+Y)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sleep Hygiene (SH)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sleep Hygiene & Yoga (SH+Y)
n=16 participants at risk
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment).
Sleep hygiene intervention: 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.
Yoga intervention: 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).
|
Sleep Hygiene (SH)
n=17 participants at risk
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.
Sleep hygiene intervention: 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.
|
|---|---|---|
|
Infections and infestations
Cellulitis (foot)
|
0.00%
0/16 • Five months.
|
5.9%
1/17 • Number of events 2 • Five months.
|
|
Skin and subcutaneous tissue disorders
Mild rash (actigraph)
|
0.00%
0/16 • Five months.
|
11.8%
2/17 • Number of events 3 • Five months.
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/16 • Five months.
|
5.9%
1/17 • Number of events 1 • Five months.
|
|
Musculoskeletal and connective tissue disorders
Back pain/spasm
|
18.8%
3/16 • Number of events 3 • Five months.
|
11.8%
2/17 • Number of events 2 • Five months.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
12.5%
2/16 • Number of events 2 • Five months.
|
5.9%
1/17 • Number of events 1 • Five months.
|
|
Infections and infestations
Root canal infection
|
6.2%
1/16 • Number of events 1 • Five months.
|
0.00%
0/17 • Five months.
|
|
Cardiac disorders
Arm and chest pain
|
12.5%
2/16 • Number of events 2 • Five months.
|
0.00%
0/17 • Five months.
|
|
Eye disorders
Scratched cornea
|
0.00%
0/16 • Five months.
|
5.9%
1/17 • Number of events 1 • Five months.
|
|
Infections and infestations
Infection
|
0.00%
0/16 • Five months.
|
5.9%
1/17 • Number of events 2 • Five months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place