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Behavioral Intervention to Promote Healthy Lifestyle Behaviors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05392218
Enrollment
50
Registered
2022-05-26
Start date
2020-04-29
Completion date
2020-09-01
Last updated
2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health-Related Behavior

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

Interventions

BEHAVIORALmotivational 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.

BEHAVIORALgeneral 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

Sponsors

Princess Nourah Bint Abdulrahman University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* confirmed or suspected COVID-19 diagnosis

Design outcomes

Primary

MeasureTime frameDescription
recruitment rate - descriptiveimmediately after the interventionreported as the number of participants' consented divide by the number of people that were invited to participate
retention rates - descriptiveimmediately after the interventionreported as the number of participants completing all study sessions
session duration - descriptiveimmediately after the interventionreported as the average session time for intervention group or attention group

Secondary

MeasureTime frameDescription
dietary habits - questionnaireoutcome measure was assessed at baseline and within 7 days from the last study sessionvia food frequency questionnaire (FFQ). data reported as count
physical activity and sedentary behavior - questionnaireoutcome measure was assessed at baseline and within 7 days from the last study sessionmeasured via Global Physical Activity. physical activity level was calculated based on responses. sedentary behavior was reported as average sitting time per day.
fear of COVID-19 - questionnaireoutcome measure was assessed at baseline and within 7 days from the last study sessionvia Fear of COVID-19 Scale (FCV-19S). score ranging from 7 to 35. The higher score indicates a higher fear of COVID-19
social support - questionnaireoutcome measure was assessed at baseline and within 7 days from the last study sessionvia Medical Outcomes Study (MOS) Social Support Survey. This tool contains 19 questions, and higher score indicates more social support
psychosocial distress - questionnaireoutcome measure was assessed at baseline and within 7 days from the last study sessionvia Kessler Psychological Distress Scale (K10). score range from 10 to 50 and higher scores reflecting higher psychological distress
sleep - questionnaireoutcome measure was assessed at baseline and within 7 days from the last study sessionvia Pittsburgh Sleep Quality Index (PSQI). score ranges from 0 to 21. Poor sleepers have ≥ 5 scores as a cut-off global score

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026