Behavioral Intervention to Promote Healthy Lifestyle Behaviors

NCT ID: NCT05392218

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-29

Study Completion Date

2020-09-01

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

Conditions

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Health-Related Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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motivational interviewing

Group Type EXPERIMENTAL

motivational interviewing

Intervention Type BEHAVIORAL

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.

attention group

Group Type SHAM_COMPARATOR

general health education

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Princess Nourah Bint Abdulrahman University

OTHER

Sponsor Role lead

Responsible Party

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Shaima Alothman

Associate Researcher, Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Princess Nourah bint Abdulrahman University

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 36611550 (View on PubMed)

Other Identifiers

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20-0142

Identifier Type: -

Identifier Source: org_study_id

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