Fit for School Health Outcome Study Cambodia

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00004507
• Date of registration: 15/01/2013
• Prospective Registration: No
• Primary sponsor: Gesellschaft für internationale Zusammenarbeit (GIZ), Manila Office
• Public title: Fit for School Health Outcome Study Cambodia
• Scientific title: Fit for School Health Outcome Study Cambodia - FIT HOS Cambodia
• Date of first enrolment: 09/11/2012
• Target sample size: 600
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00004507
• Study type: interventional
• Study design: Allocation: Non-randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: prevention
• Phase: N/A

Countries of recruitment

Cambodia

Contacts

• Name: Bella Monse
• Affiliation: Gesellschaft für internationale Zusammenarbeit (GIZ), Manila Office

• Name: Bella Monse
• Affiliation: Gesellschaft für internationale Zusammenarbeit (GIZ), Manila Office

Key inclusion & exclusion criteria

Inclusion criteria: 1. Students aged 6 to 7 years old at baseline examination time, attending grade I in school year 2012/2013.
2. Informed consent obtained from parents or legal guardian.



Exclusion criteria: 1. Parents’ refusal to let their child participate in the study.
2. Students with known systemic medical conditions and other chronic infectious diseases.
3. Students with no stool specimen submission.



Age minimum: 6 Years
Age maximum: 7 Years
Gender: All

Health Condition(s) or Problem(s) studied

B82.0

Ascariasis

B82.0
K02
E45
B76
B79
B77

Retarded development following protein-energy malnutrition

Hookworm diseases

Dental caries

Intestinal helminthiasis, unspecified

Trichuriasis

Intervention(s)

Group 1: The intervention group consists of 6 to 7 year-old students visiting grade I at one of the 10 selected public primary schools in Cambodia.

The interventions includes daily handwashing with soap done as a group activity, daily fluoride toothbrushing using 0.3 ml (pea sized) fluoride toothpaste (1,450 fluoride ppm free available fluoride) as a group activity, and the distribution of albendazole (400 mg tablet) or mebendazole (500 mg tablet) as a single dose (mass drug administration, MDA) given every months against soil-transmitted helminthiasis as per World Health Organization recommendations.

The intervention is planned to last 18 months.
Group 2: The control group consists of 6 to 7 year old grade I students visiting one of the 10 selected public primary schools that implement the regular health education program of the government such as: bi-annual de-worming (mostly using mebendazole) and annual activities on toothbrushing and handwashing.

Primary Outcome(s)

The longitudinal clustered controlled study encompasses data collection and assessment of selected information and indicators at baseline and after a 18-months period. Based on that the duration of the study is envisioned to be at least 18 months.

Data collection and assessment encompasses:

Basic socio-demographic data
This includes age, sex, number of siblings, and location of home.

Nutritional Status (BMI) status
Measurements are based on the standards described by Cogill. Height and weight are assessed to the nearest 0.1 cm and 100 grams, respectively. BMI is calculated by taking weight (in kgs) for height (in meters) squared [w(kg)/h(m)2].

Parasitological status
Stool cups are given to the children with appropriate collection instructions. Stool samples are analysed using the Kato Katz method as described in the World Health Organization Bench Aids for the Diagnosis of Intestinal Parasites. Data gathered are used to derive the cumulative prevalence rates, prevalence rates of individual helminth infections and intensities of STH infections. Assessments is done before deworming treatment starts and after 18 months.

Oral health status
All oral examinations of the schoolchildren are carried out in the school courtyard or in case of rain under a covered court. Prior to examination, children brush their teeth. Students are examined by the gloved and masked dental examiner using a battery powered headlamp to standardize examination conditions. The teeth are examined according to WHO Basic Methods. A CPI (ball-end) probe is used gently to detect and confirm visual evidence of caries. All children are examined on tooth level, only the first molar is assessed on surface level. Teeth with pulp involvement is recorded in primary as well as in permanent dentition according to PUFA/ pufa index.
Dentists are trained, calibrated, and knowledgeable with the diagnostic criteria to perform the examinations. Calibration is conducted by comparing the results of each examiner with the results of an experienced examiner (gold standard).

Prevalence of Oral Pain/Abdominal Pain
Children are interviewed concerning experience of (1) oral pain and impact of pain and (2) pain or discomfort in any part of the abdomen in order to assess if the programme could improve their quality of life. Children are given at least ten seconds to answer.

School Attendance
Information on school attendance of the students included in the examination will be taken from teachers' record books from the beginning of school year to an agreed cut off time.

Data Processing and Statistical Analysis
All data collected are entered into an electronic database using a pre-defined encoding mask, then processed and analyzed. Data are checked for completeness and consistency prior to analysis.
Descriptive statistics such as mean and prevalence proportions are determined at baseline and at follow-up for each group:
1. Prevalence of STH infections
2. Severity of STH infection (geometric mean egg counts)
3. Prevalence of dental caries
4. Caries experience (mean dmfs/t, DMFS/T)
5. Prevalence of odontogenic infection
6. Odontogenic infection experience (Mean pufa/PUFA)
7. Distribution of children according to BMI classification (%)
8. Mean BMI
8. Prevalence of children with self reported impaired quality of life
9. Average time of being absent from school (mean number of days being absent)

Statistical tests such as Student’s T-test and Chi-square test are employed to determine the presence or absence of significant differences among changes in means and proportions, respectively, between the intervention and control groups taking into account effects of clustering.

Secondary ID(s)

U1111-1135-4135

Source(s) of Monetary Support

Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH

Ethics review

Status: Approved
Approval date: 30/08/2012
Contact:

Ministry of Health of Cambodia, National Ethics Committee for Health Research

Results

• URL: http://drks.de/search/en/trial/DRKS00004507#studyResults