The effectiveness of pulse-based food supplements for undernourished pregnant mothers to improve maternal and birth outcomes: a cluster randomized controlled trial

This study aims to assess whether balanced energy protein from pulse food supplement (PFS) combined with MMS has the same effect as the government food supplements (GFS) program in Indonesia

This is a two-arm, cluster-randomized controlled trial, parallel-group, single-blind study.

The study will take place in the Tahunan Public Health Center (PHC) area of Jepara District, and the Windusari PHC area of Magelang District, Central Java Province, Indonesia from December 2022 to August 2023. Based on the District Health Office Report Year 2021, about 1000 women are pregnant each year, with antenatal care coverage of 95%, and all births being attended by skilled birth attendants.

The inclusion criteria: pregnant mothers who visit village midwives for antenatal care, with single pregnancies, gestational age at less than 28 weeks, have MUAC <23.5 cm, have no intention of moving from the area for at least 6 months and agree to sign the consent form. We will exclude mothers who have experienced previous stillbirths or miscarriages to avoid having the follow-up disrupted.

The intervention group will receive legumes food supplements in the form of cookies which contain minimally 300kcal energy and 7 grams of protein combined with multiple micronutrients of UNIMMAP from Vitamin Angel. The control group will receive usual care from the government, namely the GFS and iron folic acid (IFA) supplements. The GFS contains 300 kcal energy and 5 grams of protein per day.

The main outcome variables are maternal outcomes (gestational weight gain and maternal MUAC) and birth outcomes (birth weight, birth length, type of delivery, preterm birth)

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.

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.

Pulse food supplementation Indonesia - PulseIndonesia01

Data will be available upon request with the agreement

Scientist

For academic purposes

Principal Investigator by email at kun@poltekkes-smg.ac.id

Depending on the applicant's purposes. We will check their purposes and possibility to use the data.