1. Home
  2. Approved trials
  3. » فارسی

Investigating the Effect of a Multicomponent Healthy Lifestyle Education Program Based on Persian Medicine in Schools on the Quality of Life of Elementary School Students and Parental Self-Efficacy: A Pilot Study

Protocol summary

Study aim
To determine the effect of a multi-component healthy lifestyle education program based on ITM in schools on the quality of life of primary school students and their parents’ self-efficacy.
Design
A pilot cluster-randomized controlled trial with intervention and control groups, investigating an Iranian traditional medicine-based lifestyle education intervention among 60 parents of primary school students
Settings and conduct
This study will be conducted in public primary schools in Tehran by randomly selecting two schools from one district and allocating them as clusters to the intervention and control groups. In the intervention group, the students’ parents will receive a healthy lifestyle education program based on ITM over a 3-month period (initial in-person training followed by 3 months of virtual education). The control group will receive only routine education. Study outcomes will be evaluated at the end of the 3-month period. Blinding will not be performed in this study
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Students in grades one to three of primary school Obtaining informed written consent from a parent Minimum literacy level (ability to read and write) for the participating parent The participating parent’s access to the internet and a smartphone Exclusion Criteria: Students with chronic underlying medical conditions Students living in a single-parent household (due to death or divorce) At least one parent currently undergoing treatment for mental health conditions
Intervention groups
Intervention group: Parents of students who participate in the multi‑component healthy lifestyle education program based on Iranian traditional medicine (including educational sessions). Control group: Parents of students who receive routine education not related to ITM.
Main outcome variables
Quality of life of primary school students Parental self‑efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260621069908N1
Registration date: 2026-07-18, 1405/04/27
Registration timing: prospective

Last update: 2026-07-18, 1405/04/27
Update count: 0
Registration date
2026-07-18, 1405/04/27
Registrant information
Name
Zahra Valinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 9911
Email address
z.valineja120@sbmu.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of a Multicomponent Healthy Lifestyle Education Program Based on Persian Medicine in Schools on the Quality of Life of Elementary School Students and Parental Self-Efficacy: A Pilot Study
Public title
Investigating the Effect of Healthy Lifestyle Education Based on Iranian Traditional Medicine in Schools on the Quality of Life of Primary School Students and Parental Empowerment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Students in grades one to three of primary school (first stage of primary education) Written informed consent obtained from a parent (father or mother) Minimum literacy level (ability to read and write) for the participating parent Access to the internet and a smartphone for the participating parent
Exclusion criteria:
Students with chronic underlying medical conditions (e.g., seizures, diabetes, epilepsy, cancer, hypothyroidism, morbid obesity or underweight, autism, ADHD, etc.) Students living in single-parent households (due to bereavement or divorce) Parents who are currently undergoing treatment for psychiatric or mental health disorders (e.g., severe anger, aggression, depression, etc.)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
First, one district will be selected by simple random sampling from the educational districts. Then, two public primary schools from that district will be randomly selected. Finally, one of these schools will be randomly assigned to the intervention group and the other to the control group. The unit of randomization in this study is the ‘school’ (cluster).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Daneshjoo Boulevard, Valanjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2026-01-25, 1404/11/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1404.997

Health conditions studied

1

Description of health condition studied
Promotion of a healthy lifestyle and health-promoting behaviors, quality of life of primary school students, and parental self-efficacy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mean score of children’s health-promoting behaviors based on a researcher-made checklist (Persian Medicine-based)
Timepoint
before, immediately after, and 3 months after the intervention
Method of measurement
A Persian Medicine-based questionnaire/checklist for assessing children’s health-promoting behaviors, completed by the parents

2

Description
Quality of life of primary school students: The mean score obtained based on the questionnaire.
Timepoint
Before the intervention, immediately after the intervention, and 3 months after the intervention
Method of measurement
Pediatric Quality of Life Inventory (PedsQL), completed by parents

3

Description
Parental self-efficacy: Mean score obtained from the Parenting Self-Agency Measure (PSAM)
Timepoint
Before the intervention, immediately after the intervention, and 3 months after the intervention
Method of measurement
Parenting Self-Agency Measure (PSAM), completed by parents

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Parents of primary school students who participate in the multi-component healthy lifestyle education program based on Iranian Traditional Medicine (including educational sessions) and receive the related training
Category
Lifestyle

2

Description
Control group: Parents of students who receive only the routine school education and do not participate in the healthy lifestyle education program based on Iranian Traditional Medicine provided in this study
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected primary schools in one district of Tehran, Iran
Full name of responsible person
Reihane Alipour
Street address
No. 8, Shams Alley, Opposite Tavanir, Valiasr St., Shahid Beheshti School of Traditional Medicine, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
alipouram71@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Valinejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Opposite Tavanir, Valiasr St., Shahid Beheshti School of Traditional Medicine, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
zvalinejad1.20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reihane Alipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Opposite Tavanir, Valiasr St., Shahid Beheshti School of Traditional Medicine, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
alipouram71@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Valinejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Opposite Tavanir, Valiasr St., Shahid Beheshti School of Traditional Medicine, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
zvalinejad1.20@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...