Table 5.

Lessons learned from pilot study data & changes for Randomized Controlled Trial (RCT)

Area of intervention	Information source	Lesson learned	Planned changes for RCT*
Recruitment & retention	Community partner input	Community partners suggested holding information sessions about the study. Face to face encounters are more likely to elicit trust and promote recruitment.	Hold recruitment informational sessions in the target community.
	Focus group data	To address the underrepresentation of males in the study sample, focus group participants suggested that recruitment materials should promote the program to men specifically, and males from the program should help with recruitment	The male yoga instructor will attend the recruitment informational sessions when possible. Recruitment flyers will specify that men and women are welcome.
	Investigator observations	Highest attrition occurred among mothers of young children.	Offer babysitting and dinner for children during yoga/sleep hygiene sessions.
	Focus group data & investigator observations	Despite enthusiasm of many participants, attending sessions was difficult for participants facing life challenges (i.e., health, family issues)	To reduce the likelihood of attrition over a 12-week period, we will compensate participants with $10 gift cards for all the study sessions they attend.
	Focus group data	Participants reportedly liked receiving texts reminding them to attend classes and practice yoga and sleep hygiene at home	Continue.
Sleep hygiene intervention	Focus group data	Social support was important. Participants enjoyed hearing the challenges and solutions of other participants	For feasibility and to increase social interaction, the sleep hygiene session will be changed to two in-person sessions, versus one in-person session and an individual phone call.
	Focus group data	Participants felt that the diary was an important self-monitoring tool, and suggested shortening it	We will ask participants to complete the diary for the entirety of the RCT and will be simplified.
Yoga intervention	Focus group data, investigator observations	Participants respond to a mix of active poses and relaxation poses	Maintain yoga class structure: introduction, active poses, relaxation poses, breathing exercises
	Focus group data	Participants requested more support for home practice (e.g., audio recording)	In addition to the home manual, develop and provide downloadable audio recording and YouTube video to support home practice
Assessments	Investigator observations & focus group data	Many participants appeared to have comprehension difficulties and did not understand certain questions and wording in validated assessments	Investigators will make minor adjustments to simplify wording on questions that many participants struggled to understand. Trained staff will administer all assessments to participants.
	Focus group data & investigator observations	Participants felt that questionnaires were at times too long, repetitive, and burdensome.	Assessments will only occur at baseline and follow-up assessments. Investigators will be judicious about selecting instruments in terms of necessity and brevity.
Community partnership/engagement	Investigator observations	Investigators credited positive and productive community engagement to the following practices: -Conducting face-to-face meetings; -“Asking not telling”, asking for input on study design, materials and respecting opinions as experts in their context; -Providing community members with important materials, to enhance sense of control and ownership; -Expressing gratitude throughout the collaboration (thank you cards, etc.); -Offering to share study results in the form of manuscripts or presentations; and -Volunteering for other community activities to show support and good will	Continuation of best practices for community engagement and partnership

^*Randomized controlled trial