Health-Related BehaviorNCT05392218
Behavioral Intervention to Promote Healthy Lifestyle Behaviors
A study testing motivational interviewing and general health education in people with Health-Related Behavior, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health-Related Behavior
- What is being tested?
- motivational interviewing and general health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 29 Apr 2020to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- living in Saudi Arabia with stay home advisory
- speak Arabic
Who cannot join
- confirmed or suspected COVID-19 diagnosis
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Princess Nourah bint Abdulrahman University
Riyadh, 11321
About this study
Official title: Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility Randomized Controlled Trial
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)
Read the 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
- Conditions
- Health-Related Behavior
- Being tested
- motivational interviewing, general health education
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingBehavioural
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 educationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| motivational interviewing | Experimental | Not described Receives: Behavioral: motivational interviewing |
| attention group | Sham comparator | Not described Receives: Behavioral: general health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
recruitment rate - descriptive
reported as the number of participants' consented divide by the number of people that were invited to participate
Measured: immediately after the intervention
retention rates - descriptive
reported as the number of participants completing all study sessions
Measured: immediately after the intervention
session duration - descriptive
reported as the average session time for intervention group or attention group
Measured: immediately after the intervention
Secondary outcomes (6)
physical activity and sedentary behavior - questionnaire
measured via Global Physical Activity. physical activity level was calculated based on responses. sedentary behavior was reported as average sitting time per day.
Measured: outcome measure was assessed at baseline and within 7 days from the last study session
psychosocial distress - questionnaire
via Kessler Psychological Distress Scale (K10). score range from 10 to 50 and higher scores reflecting higher psychological distress
Measured: outcome measure was assessed at baseline and within 7 days from the last study session
sleep - questionnaire
via Pittsburgh Sleep Quality Index (PSQI). score ranges from 0 to 21. Poor sleepers have ≥ 5 scores as a cut-off global score
Measured: outcome measure was assessed at baseline and within 7 days from the last study session
dietary habits - questionnaire
via food frequency questionnaire (FFQ). data reported as count
Measured: outcome measure was assessed at baseline and within 7 days from the last study session
social support - questionnaire
via Medical Outcomes Study (MOS) Social Support Survey. This tool contains 19 questions, and higher score indicates more social support
Measured: outcome measure was assessed at baseline and within 7 days from the last study session
fear of COVID-19 - questionnaire
via Fear of COVID-19 Scale (FCV-19S). score ranging from 7 to 35. The higher score indicates a higher fear of COVID-19
Measured: outcome measure was assessed at baseline and within 7 days from the last study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start29 Apr 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health-Related BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaima Alothman, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392218
- Sponsor's protocol ID
- 20-0142
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 36611550
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05392218
- Acronym / sponsor ID
- 20-0142
- Conditions
- Health-Related Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| motivational interviewing | Experimental | Behavioral: motivational interviewing |
| attention group | Sham comparator | Behavioral: general health education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- living in Saudi Arabia with stay home advisory
- speak Arabic
Key exclusion criteria (1 listed)
- confirmed or suspected COVID-19 diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational interviewingconsisted 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. | Behavioural | motivational interviewing |
| general health educationrceived 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 | Behavioural | attention group |
Primary outcome
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
retention rates - descriptive
Time frame: immediately after the intervention
reported as the number of participants completing all study sessions
session duration - descriptive
Time frame: immediately after the intervention
reported as the average session time for intervention group or attention group
6 secondary outcomes
physical activity and sedentary behavior - questionnaire
Time frame: outcome measure was assessed at baseline and within 7 days from the last study session
psychosocial distress - questionnaire
Time frame: outcome measure was assessed at baseline and within 7 days from the last study session
sleep - questionnaire
Time frame: outcome measure was assessed at baseline and within 7 days from the last study session
dietary habits - questionnaire
Time frame: outcome measure was assessed at baseline and within 7 days from the last study session
social support - questionnaire
Time frame: outcome measure was assessed at baseline and within 7 days from the last study session
fear of COVID-19 - questionnaire
Time frame: outcome measure was assessed at baseline and within 7 days from the last study session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Derived from this study: PubMed 36611550Alothman 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing and general health education in people with Health-Related Behavior, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recruitment rate - descriptive (time frame: immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.