Role of health education for parents on childhood obesity and body weight among school children
| ISRCTN | ISRCTN17752811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17752811 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 7/5/9558 |
| Sponsor | University of Sulaymaniyah |
| Funder | Investigator-initiated and funded |
- Submission date
- 02/08/2022
- Registration date
- 11/08/2022
- Last edited
- 02/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity is now described as a disease and one of the most preventable diseases by changing diet and personal lifestyle. High body weight and obesity in childhood may have harmful consequences for this very vulnerable age group and are connected to an increased chance of obesity in adulthood. Children who are overweight or obese are at a higher risk of developing many health problems, such as high blood pressure, asthma and other respiratory problems, type 2 diabetes, liver disease and sleep disorders. Obesity may also cause psychological problems like depression, social isolation and low self-esteem. Education and early programs (e.g. in school or community-based intervention) are critical to addressing the obesity epidemic. Epidemiological and clinical studies have confirmed the role of a low-calorie diet, intensified physical activity, and cognitive strategies to change behaviours. These strategies include self-monitoring, problem-solving, planning, stress management, and gaining other children's social support in managing adolescent obesity and associated cardio-metabolic risks. Health education is required to recognize behaviour and, if necessary, replace it with new behaviour to develop an effective program. This study explores the effectiveness of a school-based educational intervention program and identifies factors associated with significant weight loss.
Who can participate?
Parents of school-age children aged between 6 to 15 years old (primary school) in Sulaimani province - Kurdistan region/Iraq
What does the study involve?
Measurement of child height, weight, and waist and hip circumference will be undertaken at a baseline measurement and before the end of the school year. Parents will be invited to participate in two different education sessions, one at the baseline measurement and another after ten weeks. The contents of the sessions will include brief introductory knowledge of childhood obesity, the cause and harms of childhood obesity, BMI references for screening overweight and obesity in school-age children, healthy eating (increasing consumption of vegetables and fruits, reducing consumption of non-healthy foods, fast foods, snacks, avoiding sugary drinks), and how to increase a child's physical activity (intensity, duration, reducing sedentary time). Educational materials like paper-printed flyers will be distributed to the parents and their children. Furthermore, the researcher will ask for help to create a household-supportive environment for healthy eating and physical activity for their children. Parents are also required to encourage and supervise their children to have a healthy lifestyle.
What are the possible benefits and risks of participating?
Participant families will benefit from the education sessions, helping them to have a better quality of life by being more active than previously, which will lower body weight and decrease their BMI range. There are no risks for participants during the study period.
Where is the study run from?
The University of Sulaimani (Iraq)
When is the study starting and how long is it expected to run for?
April 2021 to April 2022
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
1. Dr. Abdulrahman M Ibrahem
abdulrahman.ibrahem@univsul.edu.iq
2. Dr. Shahow Abdulrehman Ezzaddin
shahow.ezzaddin@univsul.edu.iq
Contact information
Public
Raparen- Zanko 101
Sulaimani
46001
Iraq
 ORCID ID |
0000-0002-5754-4071 |
|---|---|
| Phone | + 9647725255124 |
| abdulrahman.ibrahem@univsul.edu.iq |
Scientific
University of Sulaimani
College of medicine
Family and community medicine department
Sulaimani city – Kurdistan region
None available
Iraq
| Phone | +9647701563225 |
|---|---|
| Shahow.ezzaddin@univsul.edu.iq |
Scientific
University of Sulaimani
College of Medicine
Family and community medicine
Sulaimani city – Kurdistan region
None available
United Kingdom
| Phone | +9647703448596 |
|---|---|
| Bushra.ali@univsul.edu.iq |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-blind randomized controlled study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 42169 PIS .pdf |
| Scientific title | Parental participation in reducing childhood obesity and overweight among basic school students: A randomized controlled trial |
| Study objectives | Health education of parents about obesity by various methods such as face-to-face group discussion, seminar presentations and providing paper print flyers is more effective in lowering obesity and weight levels than one method such as only providing a paper print flyer |
| Ethics approval(s) | Approved 11/08/2021, Ethical Committee of The College of Medicine (Sulaimani University, New Sulaimani, Street 27- Zone 29, Sulaymaniyah, Kurdistan Region, Iraq; +9640533270924; med@univsul.edu.iq), ref: 156 |
| Health condition(s) or problem(s) studied | Reducing obesity and body weight in primary school children |
| Intervention | Current interventions as of 30/03/2023: The intervention program called 'I’m active' focuses on promoting a healthy lifestyle for overweight and obese children by providing two sessions of health education for parents. The study aims to recruit overweight or obese children whose body weight status was determined using age- and gender-specific body mass index (BMI) z-scores from one to nine grades in 15 primary schools. The schools are selected by applied stratified multistage cluster sampling from a total of 647 schools distributed into districts in the Sulaimani governorate. The schools are selected according to probability proportional to size (PPS) of the directorate of education in each district. From each of the selected schools, 20 overweight or obese children (both male and female) will be invited by convenience sampling to participate in this study. After anthropometric measurement, we will invite their parents to participate in two educational sessions and the parents will be divided randomly into two groups: a control group and the intervention group. Parents will be invited into school to participate in two education sessions ten weeks apart, the first session at the time of baseline measurements and the second session after ten weeks. Parents in the intervention group in each selected school will participate in a one-hour seminar presentation provided by the principal researcher and every parent will be provided with a paper-printed flyer containing the same information from the seminar. Parents in the control group in each selected school will be provided with the paper-printed flyer only without the seminar information. After ten weeks, a second similar session is run again for both groups. Further, there will be two rounds of anthropometric measurements, the first one is the baseline assessment and the second follow-up assessment is before the end of the school year. _____ Previous interventions: The intervention program called 'I’m active' focuses on promoting a healthy lifestyle for overweight and obese children by providing two sessions of health education for parents. The study aims to recruit overweight or obese children whose body weight status was determined using age- and gender-specific body mass index (BMI) z-scores from one to nine grades in 15 Basic schools. The schools are selected by applied stratified multistage cluster sampling from a total of 647 schools distributed into districts in the Sulaimani governorate. The schools are selected according to probability proportional to size (PPS) of the directorate of education in each district. From each of the selected schools, 20 overweight or obese children (both male and female) will be invited by convenience sampling to participate in this study. After anthropometric measurement, we will invite their parents to participate in two educational sessions and the parents will be divided randomly into two groups: a control group and the intervention group. Parents will be invited into school to participate in two education sessions ten weeks apart, the first session at the time of baseline measurements and the second session after ten weeks. Parents in the intervention group in each selected school will participate in a one-hour seminar presentation provided by the principal researcher and every parent will be provided with a paper-printed flyer containing the same information from the seminar. Parents in the control group in each selected school will be provided with the paper-printed flyer only without the seminar information. After ten weeks, a second similar session is run again for both groups. Further, there will be two rounds of anthropometric measurements, the first one is the baseline assessment and the second follow-up assessment is before the end of the school year. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The measurements were taken in the student's classroom during school hours during a baseline assessment and a second follow-up assessment before the end of the school year after six months’ duration: |
| Key secondary outcome measure(s) |
1. Demographic characteristics measured using a questionnaire at baseline to include: |
| Completion date | 28/04/2022 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | Current inclusion criteria as of 30/03/2023: 1. Primary school children aged between 6 and 18 years old who are part of the sample that was invited to participate in the study 2. Overweight or obese. If there are two children in one family who meet the inclusion criteria, they are permitted to participate as two separate individuals _____ Pervious inclusion criteria: 1. Basic school children aged between 6 and 18 years old who are part of the sample that was invited to participate in the study 2. Overweight or obese. If there are two children in one family who meet the inclusion criteria, they are permitted to participate as two separate individuals |
| Key exclusion criteria | Current exclusion criteria as of 30/03/2023: 1. Primary school children aged 5 years old and younger and 19 years old and over 2. Children with disabilities 3. Parents who refused to participate in the study _____ Previous exclusion criteria: 1. Basic school children aged 5 years old and younger and 19 years old and over 2. Children with disabilities 3. Parents who refused to participate in the study |
| Date of first enrolment | 19/09/2021 |
| Date of final enrolment | 31/10/2021 |
Locations
Countries of recruitment
- Iraq
Study participating centre
Sulaimani
46001
Iraq
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Mr Abdulrahman M. Ibrahem, abdulrahman.ibrahem@univsul.edu.iq. The data will be available for one year after publication for SPSS analysis and with no anonymisation or restriction. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 0 | 10/08/2022 | 10/08/2022 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 42169 PIS .pdf
- Participant information sheet
Editorial Notes
02/01/2024: The following changes have been made:
1. The scientific title was changed from "The effect of educational intervention in reducing childhood obesity and overweight among primary school children in Sulaimani Governorate" to "Parental participation in reducing childhood obesity and overweight among basic school students: A randomized controlled trial".
2. The public title was changed from "The effect of health education for parents on childhood obesity and body weight among school children" to "Role of health education for parents on childhood obesity and body weight among school children".
3. The upper age limit has been changed from 18 to 15 years.
4. The plain English summary has been updated to reflect these changes and correct typos.
30/03/2023: The following changes were made to the trial record:
1. The scientific title was changed from "The role of an educational intervention in lowering childhood obesity and overweight among basic school children in Sulaimani Governorate" to "The effect of educational intervention in reducing childhood obesity and overweight among primary school children in Sulaimani Governorate".
2. The condition was changed from "Lowering obesity and body weight in school children" to "Reducing obesity and body weight in primary school children".
3. The interventions were changed.
4. The inclusion criteria were changed.
5. The exclusion criteria were changed.
6. The contact was updated.
13/09/2022: Contact details updated.
10/08/2022: Trial's existence confirmed by the Ethical Committee of The College of Medicine, Sulaimani University.
