Clinical trial NCT05392218: Behavioral Intervention to Promote Healthy Lifestyle Behaviors
Official title: Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health-Related Behavior
Lead sponsor: Princess Nourah Bint Abdulrahman University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* living in Saudi Arabia with stay home advisory
* speak Arabic

Exclusion Criteria:

* confirmed or suspected COVID-19 diagnosis

Primary outcomes:
measure: recruitment rate - descriptive
timeFrame: immediately after the intervention
measure: retention rates - descriptive
timeFrame: immediately after the intervention
measure: session duration - descriptive
timeFrame: immediately after the intervention
Secondary outcomes:
measure: physical activity and sedentary behavior - questionnaire
timeFrame: outcome measure was assessed at baseline and within 7 days from the last study session
measure: psychosocial distress - questionnaire
timeFrame: outcome measure was assessed at baseline and within 7 days from the last study session
measure: sleep - questionnaire
timeFrame: outcome measure was assessed at baseline and within 7 days from the last study session
measure: dietary habits - questionnaire
timeFrame: outcome measure was assessed at baseline and within 7 days from the last study session
measure: social support - questionnaire
timeFrame: outcome measure was assessed at baseline and within 7 days from the last study session
measure: fear of COVID-19 - questionnaire
timeFrame: outcome measure was assessed at baseline and within 7 days from the last study session
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Princess Nourah bint Abdulrahman University
Study officials:
References: