NCT03946475

Brief Summary

Good nutritional status among adolescents is a window of opportunity to produce healthy adults or pregnant individuals. Modifying the dietary habits during adolescent girls may be a sustainable approach to ensure good nutritional status among population because those habits tend to stay for a life time. Over many years, there has much effort to overcome anemia. Iron supplementation and fortification have been the most popular and convenient strategies to combat anemia. However, there has not much success due to the high still prevalence of anemia among children and women reproductive age. Food-based approach has been defined as one of the most effective programs to combat or reduce the prevalence of anemia. In the meantime, food based recommendations (FBR) formulation through linear programming (LP) approach has been found to be more effective than the traditional method of developing FBRs called "trial and error". LP approach allows us to develop optimized diet for target population with addition to detect the nutrient problem in specific region. This study therefore aims to identify the nutrient problems in the community, to develop optimized FBR employing the LP approach and to assess effect of nutrition education using optimized FBR in order to improve the nutritional and hemoglobin status among adolescent schoolgirls in rural Malang City. This study was conducted in several phases: 1) cross-sectional study 2) intervention study. Cross-sectional study was aimed to formulate optimized food based recommendations using linear programming. Intervention study was performed during 20 weeks with Remaja ASIK as the tagline which means Active, Healthy, Smart, and Creative. Adolescent schoolgirls aged 14-18 years was the subject of this study and 496 subjects were selected, including 152 for first phase and 344 for third phase. In addition, selected school based on inclusion criteria: 1) not boarding schools; and 2) having large number of students. In doing data collection, we collected socioecodemoghraphic data, anthropometry, biochemical data, dietary data, and cogitive performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

February 23, 2019

Last Update Submit

December 1, 2019

Conditions

Anemia

Keywords

AnemiaLinear programmingOptimized food based recommendationsNutrition knowledgeDietary intakeDietary practicesAdolescent girlsNutrition educationIndonesia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin (g/dL)

    Hemoglobin level measured by cyanmethemoglobin in g/dL

    20 weeks

Secondary Outcomes (1)

  • Usual iron intake (mg/day)

    20 weeks

Other Outcomes (5)

  • Cognitive performance: attention

    20 weeks

  • Cognitive performance: short-term memory

    20 weeks

  • Cognitive performance: processing speed

    20 weeks

  • +2 more other outcomes

Study Arms (2)

Intervention group

OTHER

4 schools in 4 subdistrict which are divided into north and south Malang District. North area (Lawang and Singosari) and South area (Kepanjen and Gondanglegi).

Other: Intervention group

Control group

NO INTERVENTION

4 schools in 4 subdistrict which are divided into north (Sumberpucung), south (Lawang and Singosari), and east (Tumpang) Malang District.

Interventions

Intervention groupOTHER

Training of Trainers (ToT) was conducted among teacher who would deliver the messages. "Remaja ASIK" is Indonesian tagline meant "girls who are active, healthy, smart, and creative". Nutrition education was performed in every Friday, at least 30 minutes during 20 weeks. In brief, this is the key messages of optimized food based recommendations: 1) 3 meals and 2 snack every day, 2) At least 2 portions of vegetables/day including at least 5 portions/week of green leafy vegetables, 3) At least 2 portions/day of animal protein including at least 2 portions/week of liver, 4) At least 1 portion/day of tempe or tofu, 5) At least 1 portion/day of fruit, 6) At least 3 portions/week of milk.Trained teachers delivered the messages accompanied by supervisor. The delivered topics were key messages, balance nutrition, anemia, menstruation, BMI, healthy and smart, strong bone, lunch box, safe snack, and food label.

Intervention group

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale who already had menstruation
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • st or 2nd year of high school
  • years old
  • Apparently healthy

You may not qualify if:

  • Not yet menarche
  • Severe anemia (\<80 g/L)
  • Having serious illness (e.g chronic kidney disease, tuberculosis)
  • Disagree to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seameo Recfon

Jakarta, Indonesia

Location

Related Publications (7)

  • Alaofe H, Zee J, Dossa R, O'Brien HT. Education and improved iron intakes for treatment of mild iron-deficiency anemia in adolescent girls in southern Benin. Food Nutr Bull. 2009 Mar;30(1):24-36. doi: 10.1177/156482650903000103.

    PMID: 19445257RESULT

  • Ferguson EL, Darmon N, Fahmida U, Fitriyanti S, Harper TB, Premachandra IM. Design of optimal food-based complementary feeding recommendations and identification of key "problem nutrients" using goal programming. J Nutr. 2006 Sep;136(9):2399-404. doi: 10.1093/jn/136.9.2399.

    PMID: 16920861RESULT

  • Fahmida U, Kolopaking R, Santika O, Sriani S, Umar J, Htet MK, Ferguson E. Effectiveness in improving knowledge, practices, and intakes of "key problem nutrients" of a complementary feeding intervention developed by using linear programming: experience in Lombok, Indonesia. Am J Clin Nutr. 2015 Mar;101(3):455-61. doi: 10.3945/ajcn.114.087775. Epub 2014 Dec 24.

    PMID: 25733629RESULT

  • Wang D, Stewart D, Chang C, Shi Y. Effect of a school-based nutrition education program on adolescents' nutrition-related knowledge, attitudes and behaviour in rural areas of China. Environ Health Prev Med. 2015 Jul;20(4):271-8. doi: 10.1007/s12199-015-0456-4. Epub 2015 Mar 15.

    PMID: 25773683RESULT

  • Blanton C. Improvements in iron status and cognitive function in young women consuming beef or non-beef lunches. Nutrients. 2013 Dec 27;6(1):90-110. doi: 10.3390/nu6010090.

    PMID: 24379009RESULT

  • Hallberg L, Hulthen L, Garby L. Iron stores and haemoglobin iron deficits in menstruating women. Calculations based on variations in iron requirements and bioavailability of dietary iron. Eur J Clin Nutr. 2000 Aug;54(8):650-7. doi: 10.1038/sj.ejcn.1601069.

    PMID: 10951514RESULT

  • Suciyanti D, Kolopaking R, Mustafa A, Iwan S, Witjaksono F, Fahmida U. Effect of optimized food-based recommendations on nutrient intakes, hemoglobin levels, and memory performance of adolescent girls in East Java, Indonesia. Nutr J. 2025 Jan 24;24(1):13. doi: 10.1186/s12937-024-01061-w.

    PMID: 39856679DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Umi Fahmida, PhD

    SEAMEO RECFON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants did not know that they were in intervention group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention group (4 schools) received nutrition education in the same time. Meanwhile, control group (4 schools) did not received anything except for baseline and endline data collection.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2019

First Posted

May 10, 2019

Study Start

February 8, 2016

Primary Completion

May 10, 2017

Study Completion

May 10, 2017

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

The first co-Pi analyzed dietary intake data and the second co-Pi analyzed biomarkers data.

Shared Documents
SAP
Time Frame
2017-now
Access Criteria
database

Locations

ID(1)