Remaja ASIK and Optimized Food-based Recommendations

NCT ID: NCT03946475

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-08
• Study Completion Date: 2017-05-10

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.

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: OTHER

Intervention group

Intervention Type: OTHER

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 1st or 2nd year of high school

2. 14-18 years old

3. Apparently healthy

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Malang State Health Polytechnic

UNKNOWN

Sponsor Role: collaborator

Syarif Hidayatullah State Islamic University Jakarta

OTHER

Sponsor Role: collaborator

SEAMEO Regional Centre for Food and Nutrition

OTHER

Sponsor Role: lead

Responsible Party

Dr.Umi Fahmida

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Umi Fahmida, PhD

Role: PRINCIPAL_INVESTIGATOR

SEAMEO RECFON

Locations

Seameo Recfon

Jakarta, , Indonesia

Countries

Indonesia

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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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.

Reference Type: DERIVED

PMID: 39856679 (View on PubMed)

Other Identifiers

RemajaASIK

Identifier Type: -

Identifier Source: org_study_id