Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- session duration - descriptive
Study Overview
Brief Summary
in this study to "the investigators aim to improve lifestyle behaviors through behavioral interventions. Participants will be assigned to one of two groups. both groups will be asked to complete online survey before and after a 6 virtual session (twice weekly)
Detailed Description
Participants were randomly assigned into two groups (motivational interviewing intervention or attention group), using a (1:1) computer-generated randomization program (www.graphpad.com).
motivational interviewing intervention: Each session contained a different component and topic that included substance abuse, physical activity, healthy sleep, stress management, nutrition and social support. The components in order were randomized for each participant. Interviews were conducted using a video meeting platform (Zoom Video Communications Inc., 2016); with both video and audio function enabled while, participants were giving the choice to refuse video calls should they desire. Alternative session delivery method, such as phone calls were used and documented based on participant request.
attention group: received the same amount of virtual session equivalent to MI form. However, the structure of the sessions consisted of brief advice to promote healthy lifestyle delivered by different therapists. The therapist firmly and clearly discussed general lifestyle health topics and provided educational materials during each session
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •living in Saudi Arabia with stay home advisory
- •speak Arabic
Exclusion Criteria
- •confirmed or suspected COVID-19 diagnosis
Arms & Interventions
motivational interviewing
Intervention: motivational interviewing (Behavioral)
attention group
Intervention: general health education (Behavioral)
Outcomes
Primary Outcomes
session duration - descriptive
Time Frame: immediately after the intervention
reported as the average session time for intervention group or attention group
retention rates - descriptive
Time Frame: immediately after the intervention
reported as the number of participants completing all study sessions
recruitment rate - descriptive
Time Frame: immediately after the intervention
reported as the number of participants' consented divide by the number of people that were invited to participate
Secondary Outcomes
- physical activity and sedentary behavior - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- dietary habits - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- social support - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- psychosocial distress - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- sleep - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- fear of COVID-19 - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
Investigators
Shaima Alothman
Associate Researcher, Clinical Assistant Professor
Princess Nourah Bint Abdulrahman University