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Clinical Trials/NCT05392218
NCT05392218
Completed
N/A

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

Princess Nourah Bint Abdulrahman University1 site in 1 country50 target enrollmentApril 29, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health-Related Behavior
Sponsor
Princess Nourah Bint Abdulrahman University
Enrollment
50
Locations
1
Primary Endpoint
session duration - descriptive
Status
Completed
Last Updated
3 years ago

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

Registry
clinicaltrials.gov
Start Date
April 29, 2020
End Date
September 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaima Alothman

Associate Researcher, Clinical Assistant Professor

Princess Nourah Bint Abdulrahman University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • confirmed or suspected COVID-19 diagnosis

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)

Study Sites (1)

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