NCT03638557

Brief Summary

The main objective of this study is to assess the impact of the school lunch program and nutrition education towards the change in knowledge, attitude, and behavior on balanced nutrition and clean and healthy lifestyle behavior (CHLB) of adolescents living in an Islamic Boarding School. The secondary objective is to assess the program impact on energy and nutrient intake, nutrition status, hemoglobin concentration, physical fitness and concentrating ability of students. A pre-post quasi experimental design is applied to assess the impact. The intervention includes: 1) provision of nutritious lunch, meeting the nutrient requirements of adolescents for one meal, for 7 days a week, with the total duration of 220 days, 2) provision of nutrition education once a week (3 times delivered by teachers, 1 time delivered by research team) and nutrition education media, 3) capacity building of teachers and food handlers. The duration of the intervention is 1 academic year or 8 active months after the reduction of holidays and examination months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
413

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

10 days

First QC Date

August 6, 2018

Last Update Submit

August 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin concentration using Hemocue

    Hemoglobin concentration of subjects measured using Hemocue

    February-November (9 months)

Secondary Outcomes (8)

  • Body Mass Index (BMI) for age z-score

    February-November (9 months)

  • Nutrition and health knowledge using validated-structured questionnaire

    February-November (9 months)

  • Nutrition and health practices using validated-structured questionnaire

    February-November (9 months)

  • Nutrition and health attitude using validated-structured questionnaire

    February-November (9 months)

  • Nutrient intake using Semi Quantitative Food Frequency Questionnaire

    February-November (9 months)

  • +3 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

The intervention package consists of the following; 1. Balanced Nutrition and Clean and Healthy Lifestyle Behavior Education for the boarding school students (once a week with the duration of 30-60 minutes. 3 weeks are delivered by trained teachers, and 1 week by research team. 2. Nutritious lunch, for 7 days a week. With the total of 220 days. The lunch menu is designed to meet 30% of the students RDA, which consists of 635-777 Kcal and 18-22 grams of protein

Other: Nutritious Lunch

Interventions

The intervention package consists of the following; 1. Balanced Nutrition and Clean and Healthy Lifestyle Behavior Education for the boarding school students (once a week with the duration of 30-60 minutes. 3 weeks are delivered by trained teachers, and 1 week by research team. 2. Nutritious lunch, for 7 days a week. With the total of 220 days. The lunch menu is designed to meet 30% of the students RDA, which consists of 635-777 Kcal and 18-22 grams of protein

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • have resided in the boarding school at least one year
  • are anemic or underweight or stunted

You may not qualify if:

  • severely anemic with Hb concentration \< 7 g/dl
  • BMI for age z-score \<-3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darussalam Islamic Boarding School

Bogor, West Java, 16610, Indonesia

Location

MeSH Terms

Conditions

AnemiaGrowth DisordersThinness

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBody WeightSigns and Symptoms

Study Officials

  • Dr. Rimbawan

    Department of Community Nutrition, Faculty of Human Ecology, Bogor Agricultural University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: pre-post quasi experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Secretary of Department of Community Nutrition

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 20, 2018

Study Start

January 26, 2018

Primary Completion

February 5, 2018

Study Completion

March 1, 2019

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations