Behavioral Intervention to Promote Healthy Lifestyle Behaviors

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

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)

Study Overview

• Status: Completed
• Conditions: Health-Related Behavior
• Intervention / Treatment: Behavioral: motivational interviewing; Behavioral: general health education

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11321
    • Princess Nourah Bint Abdulrahman University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• confirmed or suspected COVID-19 diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: motivational interviewing	Behavioral: motivational interviewing; 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.
Sham Comparator: attention group	Behavioral: general health education; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Princess Nourah Bint Abdulrahman University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20-0142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No