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CompletedNCT03946475Updated Dec 3, 2019

Remaja ASIK and Optimized Food-based Recommendations

An interventional study of Intervention group in Anemia, sponsored by SEAMEO Regional Centre for Food and Nutrition. Completed at 1 site in Indonesia. Open to female participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by SEAMEO Regional Centre for Food and Nutrition · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Feb 2016, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
Female
01

Study 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.

Read the detailed description

Nutrition among adolescent girls has been a concern in some settings throughout the world. Even in developed countries teenage girls were found to have inadequate intake of vitamins and minerals. Similarly, Indonesian adolescent girls might have suffered from similar micronutrient deficiency. Some small studies have shown that the prevalence of anemia was relatively high among adolescent girls. 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, study has shown that iron from the dietary fortification benefited the pathogens from the gut microbiota rather than increase the iron status of the host or it can cause gut inflammation among the target population.

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. Food-based approach has been defined as one of the most effective programs to combat or reduce the prevalence of anemia. Linear programming (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 food based recommendations (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.

Eligible participants of this study were adolescent girls and meet all the inclusion criteria: 1) age: between 14-18 years 2) resident: live in rural areas of Malang district 3) willing to participate in the study 4) apparently healthy 5) already had menstruation. The list of adolescent girls from the selected high schools was obtained from each school principal. From the lists, adolescent girls was randomly selected using Random Number Apps. Those who meet the inclusion criteria was invited to participate and was given informed consent.

In the beginning of data collection, the structured interview which captures the respondents' age, address, date of birth, parents' educational and occupation, food taboo, and morbidity. The body weight was measured using SECA weighing scale and Shorr Board for height measurement. Blood specimens was collected and analyzed for levels of hemoglobin (Hb), hematocrit (Ht), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell (RBC), WBC and genetic blood disorder (hemoglobinopathy), serum ferritin, serum tranferrin receptors (TfR), and subclinincal inflammations including C-reactive protein (CRP) and a1-acid-glycoprotein (AGP). CBC analyzer was used for complete blood count whereas enzyme-linked immunoassay (ELISA) will be used to measure iron status indicators and subclinical inflammations.

Cross-sectional Study In the first phase, we conducted cross-sectional study to collect dietary data then analyzed using linear programming to obtain optimized food based recommendations. In order to develop optimized food based recommendations, we needed 152 subjects to obtain their dietary data. This sample size calculation was based on 80% power, 5% significance level, and 18.8% anemia prevalence among females and 10% absolute precision required. In the beginning of data collection, the structured interview was performed. Type of food commonly consumed and food frequency consumption per week was obtained through three days 24-hour dietary recall, 1 day weight diet record (WDR), and 3 days food records (FR). Anthropometry and biochemical measurement were assessed for each subject.

Intervention Study TIPs (Trial for Improved Practices) was conducted to pretest optimized FBR which has been developed using LP. Adolescent girls (n=20) were assessed for their actual intake using 24-hour dietary recall and last 1-week food frequency questionnaire. Afterward, they were introduced on optimized FBR and asked to practice and to write the food that are consumed in seven days food records. After one week, 24-hour dietary recall and last 1-week food frequency questionnaire were performed and group interview was conducted to identify facilitating and barriers to practicing optimized FBR.

Then, Intervention study was conducted as nutrition education in the school. As much as 144 subjects per group were randomly selected to be intervention and control group. This minimum sample size was based on 90% power, dessign effect of 2, and 20% dropout allowance. After Trial for Improved Practices (TIPs), two teachers per school were invited to join Training of Trainers (ToT) for the purpose of delivering messages of weekly nutrition education. Intervention groups received "Remaja ASIK" which is the Indonesian tagline for nutrition education in intervention schools meant "adolescent girls who are active, healthy, smart, and creative". Nutrition education was performed in every Friday, particularly in "Keputrian Session" at least 30 minutes per session during 20 weeks. Trained teachers delivered the messages of nutrition education accompanied by supervisor team. Most of materials were delivered by teaching method and several topics were delivered by poster, file presentation, showing videos and doing activities such as canteen observation, BMI calculation, and food label identification.

The effect of intervention was evaluated by nutrition knowledge, dietary intake, nutritional status, and cognitive performance. The nutrition knowledge questionnaire was generated by the team and was administered using close-ended format in baseline and endline. Dietary intake used food frequency questionnaire and three days non consecutive 24-H recall in baseline and endline. Nutritional status was determined by anthropometry and biochemical measurements. Cognitive test were administered by one well-trained enumerators who received training from psychologist to ensure standardization in the measurement and scoring procedures. Data analysis was performed using SPSS version 20. Socioeconomic status of the two groups were compared using mann-whitney test and chi-square test. The difference of changes in nutrition knowledge both of between group and within group were then analyzed by chi-square test and mcNemar test, respectively. Then, repeated measures general linear model was used to analyze the differences of dietary intake, nutritional status, and cognitive performance between group. Statistical significance was set at p\<0.05.

02

Conditions studied

  • Anemia

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Keywords

  • Anemia
  • Linear programming
  • Optimized food based recommendations
  • Nutrition knowledge
  • Dietary intake
  • Dietary practices
  • Adolescent girls
  • Nutrition education
  • Indonesia
03

In context

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

This study's enrollment of 324 is above the median of 117 across 1,336 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

SEAMEO Regional Centre for Food and Nutrition is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 1st or 2nd year of high school
  2. 14-18 years old
  3. Apparently healthy

Exclusion criteria

Exclusion Criteria:

  1. Not yet menarche
  2. Severe anemia (\<80 g/L)
  3. Having serious illness (e.g chronic kidney disease, tuberculosis)
  4. Disagree to participate
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
324 participants (actual)

Study arms

  • Other
    Intervention group

    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

  • No intervention
    Control group

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

Interventions

  • OtherIntervention group

    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.

06

What researchers measure

Primary outcomes

  1. Hemoglobin (g/dL)

    Hemoglobin level measured by cyanmethemoglobin in g/dL

    Time frame: 20 weeks

Secondary outcomes

  1. Usual iron intake (mg/day)

    Measured by 3d non consecutive 24-h recalls

    Time frame: 20 weeks

Other outcomes

  1. Cognitive performance: attention

    WISC-III Digit span measured attention. The maximum number of digits is limited to 7. Strings of digits were read by well-trained enumerators. Then, subjects were asked to re-write the number.

    Time frame: 20 weeks

  2. Cognitive performance: short-term memory

    WISC-III Digit span measured short-term memory. The maximum number of digits is limited to 7. Strings of digits were read by well-trained enumerators. Then, subjects were asked to re-write the number.

    Time frame: 20 weeks

  3. Cognitive performance: processing speed

    WISC-III Coding measured processing speed. In the test, symbols paired with digits are presented. Then, subjects were asked to rewrite within 120s. A score of 1 is given for each correct answer. IST captured processing speed. Well-trained enumerators asked subjects to read and to memorize given paper during 3 minutes. Then, subjects answered the questions during 6 minutes.

    Time frame: 20 weeks

  4. Cognitive performance: predictive IQ

    Raven's Standard Progressive Matrices capture predictive IQ. This comprises of 5 group (10-15 questions). Subjects were asked to fill given answer sheets.

    Time frame: 20 weeks

  5. Nutrition knowledge

    The nutrition knowledge questionnaire was generated by the team and was administered using close-ended format in baseline and endline data collection. The questionnaire was included 15 questions covering the following three items of nutrition knowledge: optimized food based recommendations (4 questions), anemia (4 questions), and problem nutrients and their food sources (7 questions). A positive score was corrected answer. The percentage of subjects who had corrected answer for each questions was compared between group.

    Time frame: 20 weeks

07

Study locations

1 site
  • Seameo Recfon
    Jakarta, Indonesia
08

References and documents

Publications

  • 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. PubMed 19445257 ↗
  • 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. PubMed 16920861 ↗
  • 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. PubMed 25733629 ↗
  • 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. PubMed 25773683 ↗
  • 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. PubMed 24379009 ↗
  • 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. PubMed 10951514 ↗

Individual participant data

Plan to share: Yes — The first co-Pi analyzed dietary intake data and the second co-Pi analyzed biomarkers data.

Supporting information: Statistical analysis plan

Time frame: 2017-now

Access criteria: database

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2016 to primary completion in May 2017, 15 months.

Of 163 non-industry interventional studies with no phase under Anemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 30. This study's 15 months is below that.

Counting every sponsor, half of 177 studies reached it within 17 months; a quarter within 7 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2019
First posted
May 10, 2019
StartActual
Feb 8, 2016
Primary completionActual
May 10, 2017
CompletionActual
May 10, 2017
Last update
Dec 3, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03946475
Lead sponsor
SEAMEO Regional Centre for Food and Nutrition
Collaborators
Malang State Health Polytechnic, Syarif Hidayatullah State Islamic University Jakarta
Responsible party
Dr.Umi Fahmida (Principal Investigator, SEAMEO Regional Centre for Food and Nutrition) — Principal investigator
First posted
May 10, 2019
Start date
Feb 8, 2016
Primary completion
May 10, 2017
Completion
May 10, 2017
Last update
Dec 3, 2019

Study contacts

Umi Fahmida, PhD
principal investigator · SEAMEO RECFON

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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