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Completed

NCT Number: NCT05392218

Behavioral Intervention to Promote Healthy Lifestyle Behaviors

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)

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Key information

Conditions

Health-Related Behavior Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Nourah bint Abdulrahman University

Riyadh, 11321, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • confirmed or suspected COVID-19 diagnosis

Treatment and study plan

Motivational Interviewing

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.

General health education

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

Primary outcomes

  1. 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

  2. retention rates - descriptive

    Time frame: immediately after the intervention

    reported as the number of participants completing all study sessions

  3. session duration - descriptive

    Time frame: immediately after the intervention

    reported as the average session time for intervention group or attention group

Secondary outcomes

  1. physical activity and sedentary behavior - questionnaire

    Time frame: outcome measure was assessed at baseline and within 7 days from the last study session

    measured via Global Physical Activity. physical activity level was calculated based on responses. sedentary behavior was reported as average sitting time per day.

  2. psychosocial distress - questionnaire

    Time frame: outcome measure was assessed at baseline and within 7 days from the last study session

    via Kessler Psychological Distress Scale (K10). score range from 10 to 50 and higher scores reflecting higher psychological distress

  3. sleep - questionnaire

    Time frame: outcome measure was assessed at baseline and within 7 days from the last study session

    via Pittsburgh Sleep Quality Index (PSQI). score ranges from 0 to 21. Poor sleepers have ≥ 5 scores as a cut-off global score

  4. dietary habits - questionnaire

    Time frame: outcome measure was assessed at baseline and within 7 days from the last study session

    via food frequency questionnaire (FFQ). data reported as count

  5. social support - questionnaire

    Time frame: outcome measure was assessed at baseline and within 7 days from the last study session

    via Medical Outcomes Study (MOS) Social Support Survey. This tool contains 19 questions, and higher score indicates more social support

  6. fear of COVID-19 - questionnaire

    Time frame: outcome measure was assessed at baseline and within 7 days from the last study session

    via Fear of COVID-19 Scale (FCV-19S). score ranging from 7 to 35. The higher score indicates a higher fear of COVID-19

Sponsors and collaborators

Lead sponsor

Princess Nourah Bint Abdulrahman University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 26, 2022
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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