Food and nutrition education to reduce obesity among school-age children in Panama
| ISRCTN | ISRCTN28920505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28920505 |
| Secondary identifying numbers | TCPPAN3606 |
- Submission date
- 27/03/2019
- Registration date
- 29/03/2019
- Last edited
- 28/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This is a study to prevent and reduce the prevalence of overweight and obesity in school-age children in Panama which is a growing problem. The study seeks to develop, validate and evaluate a comprehensive intervention program in food and nutrition education (FNE) at public schools under the perspective of an intersectoral public health and education policy. It is thought that FNE could be effective in school environments. However, the country does not have a national policy to prevent malnutrition problems in school population. The main aim of this study is to collect data that will inform the design of a large and national intersectoral public policy to promote healthy dietary practices in public and private schools against overweight and obesity in Panama.
Who can participate?
School-age children in elementary schools in Panama.
What does the study involve?
Participants are distribute in three healthy program schools or two regular schools (without healthy program) plus FNE activities. The student under the Healthy Program are expected to achieve an adequate state of physical, mental and social health; and create an environment of institutional and communal well-being through the promotion of healthy lifestyles. The FNE involves a comprehensive package of interventions during the school period 2019 such as games, teather plays, regulation of unhealthy products in the schools, publicity prohibition of unhealthy foods , use of pedagogical school gardens, etc. Follow-up interviews and measurements are conducted by field research assistants 12 and 30 weeks later, who assess anthropometric, dietary, and psychometric indicators. Interviews with student, teachers and parents are also conducted to assess the acceptability of the interventions.
What are the possible benefits and risks of participating?
This study does not involve any physical risks or harm to participants or the researchers.
Where is the study run from?
The selected educational schools correspond to the Victoria D’Spinay and La Herradura schools located in the District of La Chorrera; the Hernando Bárcenas school located in the District of Capira; and El Espavé and Berta Elida Fernández schools, located in the District of Chame. La Herradura, Hernando Bárcenas and Berta Elida Schools are part of the intersectoral program called "Healthy Schools".
When is the study starting and how long is it expected to run for?
April 2019 to December 2019.
Who is funding the study?
Food and Agriculture Organization (FAO) of the United Nations in Panama; and also funds has been provided by the Mesoamerica without Hunger Program of the FAO and Mexican international Cooperation Agency (AMEXID).
Who is the main contact?
Prof. Israel Ríos-Castillo
israel.rios@up.ac.pa / israel.rios@fao.org
Contact information
Scientific
City of Knowledge, Panama
Building 238, Clayton, Panama
Panama City
-
Panama
 ORCID ID |
0000-0001-9443-3189 |
|---|---|
| Phone | +5073010326 |
| israel.rios@fao.org |
Study information
| Study design | Quasi-experimental, non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Food and nutrition education against overweight and obesity in school-age children designing a public policy against malnutrition in school-age children in Panama |
| Study acronym | FNE |
| Study objectives | A multisectoral food and nutrition policy improves anthropometric and psychosocial indicators in school-age children in Panama. |
| Ethics approval(s) | Approved 25/03/2019, the Bioethics Committee of the University of Panama, (University Post Office (Estafeta Universitaria), Panama, Republic of Panama; comitebioetica.invup@up.ac.pa; +507 523-5769), ref: NºCBUP/075/2019. |
| Health condition(s) or problem(s) studied | Malnutrition |
| Intervention | This is a quasi experimental, prospective and non-controlled study to develop and validate a comprehensive food and nutrition education against overweight and obesity among school-age children in Panama. The follow-up will be the school year 2019 (approximately 9 months, from April to December 2019). The measurements include three points, at the beginning (April 2019); intermediate evaluation (July 2019); and final evaluation (Nov-Dec 2019). This is a non-controlled study because it is not ethical to carry out this type of studies that include benefits on the health of children, so a pre-post design is proposed prospective intervention, being the pre period the control of each student. The universe for this study are 1458 students from fourth to sixth grade in the five public schools selected in Panama West Province. The sample size was calculated to determine a change, pre to post intervention, of 5% in the overweight prevalence under the following criteria: 95% of confidentiality, an estimation error of 3%, and using an estimate prevalence of overweight reported by a national survey in 2008 of 26.9%. The total sample estimated is 768 students of both gender, this sample include an additional of 20% for potential losses during the following. The nutritional education interventions under a policy framework include the implementation of: 1. Kiosk regulation, in which the sale of unhealthy products is prohibited (MoH Resolution Nº49 of 2018 and Ministry of Education Resolution Nº3623 of 2018) 2. Cooking workshops involving teachers, parents and students to promote healthy dietary practices and based on the national food dietary guidelines 3. Ludic activities such as games, plays, etc. to promote healthy dietary practices, water consumption and physical activities 4. Using of pedagogical school gardens as part of subjects and as science laboratory 5. Increasing physical activities and team games during all days 6. Ensuring safe water at school. It is also highlighted the recent national law of tax for sodas, drinks and high sugar juices; and the law Nº75 of 2017 that propose healthy dietary practices at schools (https://www.gacetaoficial.gob.pa/pdfTemp/28406/GacetaNo_28406_20171115.pdf). All the food and nutrition activities were developed and validated before the trial implementation in two short-term pilots in 2018 (data not published). As well as, the KAP instrument was validated using psychometric measurements such as factor analysis, Kaiser-Mayer Olkin and Cronbach Alpha. All these analysis provides a tested instrument, with acceptable psychometric properties, which can be potentially used to measure healthy eating habits and lifestyles in school-age children in Panama. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Nutritional status is measured at baseline, 20 and 30 weeks and using: 1.1. BMI-for-age z-scores (BAZ). 1.2. Waist circumference. 1.3. Percentage of body fat. 1.4. Proportion of overweight children. 1.5. Proportion of obese children. 2. Knowledge of, attitude to, perception of and behaviour regarding dietary practices is measured using a valid and reliable instrument with 51 items (14 of knowledge about the national food-based dietary guidelines, and 37 items for attitude, perception and behaviour regarding healthy dietary practices) at baseline, 20 and 30 weeks. |
| Secondary outcome measures | 1. Dietary intake of micro and micronutrients is measured using a valid method of 24-hour recall, the analysis and interpretation will be based on the food composition table and dietary requirements for age and sex, both instruments of the Institute of Nutrition of Central America and Panama (INCAP, for its acronyms in Spanish) at baseline, 20 and 30 weeks. 2. Household food insecurity is measured using the Latin America and the Caribbean food insecurity scale (ELCSA, for its acronyms in Spanish) (http://www.fao.org/3/a-i30651.pdf) at baseline, 20 and 30 weeks. 3. Dietary diversity is measured using the household and individual dietary diversity index (http://www.fao.org/3/a-i1983e.pdf) at baseline, 20 and 30 weeks. |
| Overall study start date | 19/08/2018 |
| Completion date | 15/12/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 700 |
| Total final enrolment | 504 |
| Key inclusion criteria | Fourth to sixth grade (9-12 years old) |
| Key exclusion criteria | none |
| Date of first enrolment | 08/04/2019 |
| Date of final enrolment | 10/05/2019 |
Locations
Countries of recruitment
- Panama
Study participating centres
La Chorrera
-
Panama
La Chorrera
-
Panama
Capira
-
Panama
Chame
-
Panama
Chame
-
Panama
Sponsor information
Other
City of Knowledge, Panama
Building 238, Clayton, Panama
Panama City
-
Panama
| Phone | +5073010326 |
|---|---|
| israel.rios@fao.org | |
| Website | http://www.fao.org |
"ROR" |
https://ror.org/00pe0tf51 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | instrument development abstract | 01/07/2019 | 18/07/2019 | No | No |
| Protocol article | protocol | 13/06/2020 | 12/06/2020 | Yes | No |
| Other publications | instrument development paper | 18/06/2020 | 15/06/2020 | Yes | No |
| Dataset | Stata dataset file | 28/06/2023 | No | No | |
| Other publications | Validation of materials | 01/01/2022 | 28/06/2023 | Yes | No |
| Results article | 06/05/2023 | 28/06/2023 | Yes | No | |
| Thesis results | 28/06/2023 | No | No |
Additional files
- ISRCTN28920505 dataset BD POeste vfinal.dta
- Stata dataset file
Editorial Notes
28/06/2023: The following changes were made to the trial record:
1. Publication reference added.
2. Link to thesis added.
3. Link to dataset added.
15/06/2020: The following changes were made to the trial record:
1. Uploaded document removed as it is not the study protocol. A link to the protocol was added to the Publication list on 12/06/2020.
2. A link to the instrument development paper was added to the Publication list.
12/06/2020: Publication reference added.
18/07/2019: Publication reference added.
12/06/2019: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The intention to publish date was changed from 30/09/2019 to 31/12/2020.
05/04/2019: Internal review.
01/04/2019: Uploaded protocol (not peer reviewed).
29/03/2019: Trial's existence confirmed by the Bioethics Committee of the University of Panama.
