NCT05392218

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

May 9, 2022

Last Update Submit

May 22, 2022

Conditions

Health-Related Behavior

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • physical activity and sedentary behavior - 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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

motivational interviewing

EXPERIMENTAL
Behavioral: motivational interviewing

attention group

SHAM COMPARATOR
Behavioral: general health education

Interventions

motivational interviewingBEHAVIORAL

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.

motivational interviewing
general health educationBEHAVIORAL

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

attention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • confirmed or suspected COVID-19 diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Nourah bint Abdulrahman University

Riyadh, 11321, Saudi Arabia

Location

Related Publications (1)

  • Alothman SA, Alshehri MM, Almasud AA, Aljubairi MS, Alrashed I, Abu Shaphe M, Alghannam AF. Virtual Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility RCT during COVID-19 Pandemic. Healthcare (Basel). 2022 Dec 28;11(1):91. doi: 10.3390/healthcare11010091.

    PMID: 36611550DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Researcher, Clinical Assistant Professor

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 26, 2022

Study Start

April 29, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Locations

SA(1)