Behavioral Intervention to Promote Healthy Lifestyle Behaviors

Study Overview
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Brief Summary
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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
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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

Official Title
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Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility Randomized Controlled Trial

Conditions
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Health-Related Behavior

Intervention / Treatment
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* Behavioral: motivational interviewing
* Behavioral: general health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: living in Saudi Arabia with stay home advisory speak Arabic Exclusion Criteria: confirmed or suspected COVID-19 diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: motivational interviewing<br> | Behavioral: motivational interviewing<br>* consisted of six sessions (twice each week) up to 30 minutes of individual sessions. 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.<br>|
| Sham Comparator: attention group<br> | Behavioral: general health education<br>* rceived 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recruitment rate - descriptive | reported as the number of participants' consented divide by the number of people that were invited to participate | immediately after the intervention | 
| retention rates - descriptive | reported as the number of participants completing all study sessions | immediately after the intervention | 
| session duration - descriptive | reported as the average session time for intervention group or attention group | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity and sedentary behavior - questionnaire | measured via Global Physical Activity. physical activity level was calculated based on responses. sedentary behavior was reported as average sitting time per day. | outcome measure was assessed at baseline and within 7 days from the last study session | 
| psychosocial distress - questionnaire | via Kessler Psychological Distress Scale (K10). score range from 10 to 50 and higher scores reflecting higher psychological distress | outcome measure was assessed at baseline and within 7 days from the last study session | 
| sleep - questionnaire | via Pittsburgh Sleep Quality Index (PSQI). score ranges from 0 to 21. Poor sleepers have ≥ 5 scores as a cut-off global score | outcome measure was assessed at baseline and within 7 days from the last study session | 
| dietary habits - questionnaire | via food frequency questionnaire (FFQ). data reported as count | outcome measure was assessed at baseline and within 7 days from the last study session | 
| social support - questionnaire | via Medical Outcomes Study (MOS) Social Support Survey. This tool contains 19 questions, and higher score indicates more social support | outcome measure was assessed at baseline and within 7 days from the last study session | 
| fear of COVID-19 - questionnaire | via Fear of COVID-19 Scale (FCV-19S). score ranging from 7 to 35. The higher score indicates a higher fear of COVID-19 | outcome measure was assessed at baseline and within 7 days from the last study session |