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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Remaja ASIK and Optimized Food-based Recommendations

Clinicaltrials.gov identifier NCT03946475

Recruitment Status Completed

First Posted May 10, 2019

Last update posted December 3, 2019

Study Description

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.

  • Condition or Disease:Anemia
  • Intervention/Treatment: Other: Intervention group
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 324 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: 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.
  • Masking: Single (Participant)
  • Primary Purpose: Prevention
  • Official Title: Local Specific Food-based Recommendations Developed Using Linear Programming Approach for Combating Anemia Among Adolescent Schoolgirls in Rural Indonesia
  • Actual Study Start Date: February 2016
  • Actual Primary Completion Date: May 2017
  • Actual Study Completion Date: May 2017
Arms and interventions
Arm Intervention/treatment
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
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.
Outcome Measures
  • Primary Outcome Measures: 1. Hemoglobin (g/dL) [ Time Frame: 20 weeks ]
    Hemoglobin level measured by cyanmethemoglobin in g/dL
  • Secondary Outcome Measures: 1. Usual iron intake (mg/day) [ Time Frame: 20 weeks ]
    Measured by 3d non consecutive 24-h recalls
  • Other Outcome Measures: 1. Cognitive performance: attention [ Time Frame: 20 weeks ]
    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.
  • 2. Cognitive performance: short-term memory [ Time Frame: 20 weeks ]
    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.
  • 3. Cognitive performance: processing speed [ Time Frame: 20 weeks ]
    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.
  • 4. Cognitive performance: predictive IQ [ Time Frame: 20 weeks ]
    Raven's Standard Progressive Matrices capture predictive IQ. This comprises of 5 group (10-15 questions). Subjects were asked to fill given answer sheets.
  • 5. Nutrition knowledge [ Time Frame: 20 weeks ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 14 to 18 Years (Child, Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

Indonesia
Seameo Recfon
Jakarta

Sponsors and Collaborators

SEAMEO Regional Centre for Food and Nutrition

Malang State Health Polytechnic

Syarif Hidayatullah State Islamic University Jakarta

Investigators

Principal Investigator: Umi Fahmida, PhD SEAMEO RECFON

More Information