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IRCT20221125056601N1 IRCT 2022-12-28 Semarang Health Polytechnic Pulse-based food supplements for undernourished pregnant mothers The effectiveness of pulse-based food supplements for undernourished pregnant mothers to improve maternal and birth outcomes: a cluster randomized controlled trial 2023-01-02 anticipated 120 Complete https://irct.ir/trial/67047 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The sample size was calculated using STATA 15 command of "clustersampsi, binomial power p1(0.55) p2(0.12) m(4) k(10) rho(0.01) size_cv(0.9) base_correl(0)~" resulting 60 participants per group, Randomization description: This will be cluster randomization with a village as a unit of assignment. We will use the random number formula in an Excel spreadsheet. In order to have a balanced number of pregnant women in the intervention and control group, stratified randomization will be used based on the number of undernourished pregnant mothers in the village (3-6, and >=7 ). A statistician will perform randomization of the 20 villages for the intervention and control group, and then the field researcher will execute the result, Blinding description: The participants will be blinded. The nature of the dietary intervention study is impractical to blind the cooks, dietitians and the study staff responsible for preparing the foods and taking all measurements of the diets. An effort will be made to blind the study participants in the intervention assignment, including 1. The participants will not be told of their group assignment 2. The study will employ a cluster randomized controlled trial, with a village as a unit of assignment. Therefore, the two groups will consume their food supplement in separate villages and presumably will not meet each other. 3. Both groups will receive food and nutrient supplements using similar nutrient content. The intervention group will receive ‘pulse cookies’ as food supplements combined with multiple micronutrients and the one for control will receive fortified food supplements as the government program. 4. Both groups will receive nutrition education in different classes, places, and schedules. 3 Pregnant mothers with mid-upper arm circumference (MUAC) <23.5cm. Intervention 1: Intervention group. The intervention group will receive firstly, ‘Pulse based cookies’ as local food supplements (PFS), approximately 80-85 grams cookies that contain 400-450 kcal energy, 10-13 grams protein, and 22-30 grams fat. PBC consist of 8 types of cookies, each cookie is made from pulses (i.e. soybean, green bean, red bean, or brown bean), vegetable oil, white sugar, egg, instant yeast, guar gum, skim milk, peanut or coconut, and salt. Secondly, Multiple micronutrition supplementation (MMS) as UNIMMAP that contain Vitamin A (as palmitate or acetate) 800 µg RE (2667 IU), Vitamin C (Ascorbic acid) 70 mg, Vitamin D (as 5 µg Cholecalciferol) 5 µg (200 IU), Vitamin E (10 mgα-TE) (as dl-alpha tocopheryl acetate) 15 IU, Vitamin B1 (Thiamine mononitrate) 1.4 mg, Vitamin B2 (Riboflavin) 1.4 mg, Vitamin B3 (Niacinamide) 18 mg, Vitamin B6 (Pyridoxine HCl) 1.9 mg , Folate (from Folic Acid) 680 µg DFE (400 µg Folic Acid), Vitamin B12 (Cyanocobalamin) 2.6 µg, Iron (Ferrous Fumarate) 30 mg , Iodine (Potassium Iodide) 150 µg , Zinc (Zinc Sulphate) 15 mg, Selenium (Sodium Selenite) 65 µg , Copper (Copper Citrate) 2 mg. Third, a 1-day class training on maternal health and early life nutrition. The trainers will be from PHCs and the researchers. The trainers will be provided with PowerPoint presentation slides, while participants will receive two booklets of the slides. The supplements (PFS and MMS) will be given for 90 days duration, and a package of 30 days’ supplements will be given at the training and another 60 days’ package will be delivered at week four and eight. Intervention 2: Control group. The control group will receive firstly, the Government food supplements (GFS), approximately 60 grams cookies that contain 300 kcal energy, 3 grams protein, and 22-30 grams fat. The GFS is fortified with multiple micronutrition, namely energy 300 Kcal , Total fat 15.6 g, Protein 3 g, Carbohydrate 34.8 g, Natrium 141 mg, Vitamin A 275.22 RE, Vitamin D 7.5 mcg, Vitamin E 7.08 mg, Vitamin B1 0.48 mg, Vitamin B2 0.48 mg, Vitamin B3 5.34 mg, Vitamin B5 1.8 mg, Vitamin B6 0.54 mg, Vitamin B9 198 mcg, Vitamin B12 0.84 mcg, Vitamin C 28.2 mg, Calcium 261.6 mg, Phosphor 194.4 mg, iron 6.96 mg, Iodium 51.6 mg, Zink 4.2 mg, Selenium 19.2 mcg, Fluor 0.18 mg, water 1.764 g. Secondly, a 1-day class training on maternal health and early life nutrition. The trainers will be from PHCs and the researchers. The trainers will be provided with PowerPoint presentation slides, while participants will receive two booklets of the slides. The GFS will be given for 90 days duration, and a package of 30 days’ supplements will be given at the training and another 60 days’ package will be delivered at week four and eight. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Kun A Susiloretni
Jl. Wolter Monginsidi 115
Semarang Indonesia 50192 +62 622 46710378 kun@poltekkes-smg.ac.id Semarang Health Polytechnic scientific Kun A Susiloretni
Jl. Wolter Monginsidi 115
Semarang Indonesia 50192 +62 622 46710378 kun@poltekkes-smg.ac.id Semarang Health Polytechnic Indonesia Indonesia pregnant women with mid-upper arm circumference (MUAC) <23.5 cm gestational age at less than 28 weeks single pregnancy had no intention of moving from the area for at least 6 months had visited village midwives for antenatal care no limit no limit Female pregnant women had experienced previous stillbirth or miscarriage O25.11 Malnutrition in pregnancy, first trimester Treatment - Other Other Intervention group. The intervention group will receive firstly, ‘Pulse based cookies’ as local food supplements (PFS), approximately 80-85 grams cookies that contain 400-450 kcal energy, 10-13 grams protein, and 22-30 grams fat. PBC consist of 8 types of cookies, each cookie is made from pulses (i.e. soybean, green bean, red bean, or brown bean), vegetable oil, white sugar, egg, instant yeast, guar gum, skim milk, peanut or coconut, and salt. Secondly, Multiple micronutrition supplementation (MMS) as UNIMMAP that contain Vitamin A (as palmitate or acetate) 800 µg RE (2667 IU), Vitamin C (Ascorbic acid) 70 mg, Vitamin D (as 5 µg Cholecalciferol) 5 µg (200 IU), Vitamin E (10 mgα-TE) (as dl-alpha tocopheryl acetate) 15 IU, Vitamin B1 (Thiamine mononitrate) 1.4 mg, Vitamin B2 (Riboflavin) 1.4 mg, Vitamin B3 (Niacinamide) 18 mg, Vitamin B6 (Pyridoxine HCl) 1.9 mg , Folate (from Folic Acid) 680 µg DFE (400 µg Folic Acid), Vitamin B12 (Cyanocobalamin) 2.6 µg, Iron (Ferrous Fumarate) 30 mg , Iodine (Potassium Iodide) 150 µg , Zinc (Zinc Sulphate) 15 mg, Selenium (Sodium Selenite) 65 µg , Copper (Copper Citrate) 2 mg. Third, a 1-day class training on maternal health and early life nutrition. The trainers will be from PHCs and the researchers. The trainers will be provided with PowerPoint presentation slides, while participants will receive two booklets of the slides. The supplements (PFS and MMS) will be given for 90 days duration, and a package of 30 days’ supplements will be given at the training and another 60 days’ package will be delivered at week four and eight. Control group. The control group will receive firstly, the Government food supplements (GFS), approximately 60 grams cookies that contain 300 kcal energy, 3 grams protein, and 22-30 grams fat. The GFS is fortified with multiple micronutrition, namely energy 300 Kcal , Total fat 15.6 g, Protein 3 g, Carbohydrate 34.8 g, Natrium 141 mg, Vitamin A 275.22 RE, Vitamin D 7.5 mcg, Vitamin E 7.08 mg, Vitamin B1 0.48 mg, Vitamin B2 0.48 mg, Vitamin B3 5.34 mg, Vitamin B5 1.8 mg, Vitamin B6 0.54 mg, Vitamin B9 198 mcg, Vitamin B12 0.84 mcg, Vitamin C 28.2 mg, Calcium 261.6 mg, Phosphor 194.4 mg, iron 6.96 mg, Iodium 51.6 mg, Zink 4.2 mg, Selenium 19.2 mcg, Fluor 0.18 mg, water 1.764 g. Secondly, a 1-day class training on maternal health and early life nutrition. The trainers will be from PHCs and the researchers. The trainers will be provided with PowerPoint presentation slides, while participants will receive two booklets of the slides. The GFS will be given for 90 days duration, and a package of 30 days’ supplements will be given at the training and another 60 days’ package will be delivered at week four and eight. Birth length of the baby born by the mother. Timepoint: 1-3 days after birth. Method of measurement: Measured by baby length board of SECA. Birthweight. Timepoint: 1-3 days after birth. Method of measurement: Measured by SECA baby's digital scale. Mode of delivery. Timepoint: 1-3 days after birth. Method of measurement: Hospital/PHC record. Maternal MUAC. Timepoint: after 90 days of intervention. Method of measurement: Measured on the non-dominant arm without sleeved garment using non-stretch tape made of fibreglass. Gestational weight gain. Timepoint: after 90 days of intervention. Method of measurement: Measured by SECA digital scale. Birthweight. Timepoint: 1-3 days after birth. Method of measurement: Measured with digital scale of SECA Brand. Semarang Health Polytechnic Approved 2022-04-25 HEALTH RESEARCH ETHICS COMMITTEE POLTEKKES KEMENKES SEMARANG Jl. Tirto Agung, Pedalangan, Banyumanik, Semarang Semarang Central Java Indonesia