Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

Protein Supplementation of Snakehead Fish Cookies on Pregnant Women to Prevent Intrauterine Growth Restriction and Low Birth Weight in Sleman District, Yogyakarta Province, Indonesia: a Randomized Controlled Trial Study

This study was randomized controlled trial study whose subjects were pregnant women in Sleman District, Yogyakarta, Indonesia. The aims of this study were to make snakehead fish cookies formula which can be well accepted by pregnant women and to observed its effect on fetal growth and birth weight and length. It was hypothesized that snakehead fish cookies could prevent intrauterine fetal growth (IUGR) and low birth weight (LBW).

Subjects on this study were randomly allocated into two groups which were treatment and control group. Subjects in treatment group were given snakehead fish cookies, while subject in control group received standard cookies. The intervention period lasted until subjects delivered their babies.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Dietary supplement: cookies

Detailed Description

Subjects were enrolled from Public Health Center (puskesmas) in Sleman District, Yogyakarta Province, Indonesia. Subjects were being explained about the study intervention and were given informed consent as an approval of joining this study. The intervention was given everyday as much as 75g cookies for several weeks period (until delivery). Examination on fetal growth was done every month for each subjects. Birth weight and length were collected after delivery from child health book record.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Yogyakarta
    • Sleman, Yogyakarta, Indonesia
      • Public Health Center (Puskesmas) in the area of Sleman District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. second and third trimester gestational age,
2. lower-class family with income under Sleman District minimum wage in 2019 (< 1,701,000 Rupiah),
3. pregnant women of under 25 years old, and
4. high school graduate or below

Exclusion Criteria:

1. suffering from anemia,
2. experiencing preeclampsia,
3. having multiple gestational, and
4. allergic to fish, eggs, and chocolate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Snakehead fish cookies; Subjects who were given intervention of snakehead fish cookies during the study period	Dietary supplement: cookies; Either snakehead fish cookies or standard cookies were given to subjects 75g per day.
Placebo Comparator: Standard cookies; Subjects who were in control group and received standard cookies	Dietary supplement: cookies; Either snakehead fish cookies or standard cookies were given to subjects 75g per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated fetal weight (EFW)	We measured EFW monthly using 2D ultrasonography (USG) for each subjects	change from baseline EFW after 1 month
Biparietal diameter (BPD)	We measured BPD monthly using 2D ultrasonography (USG) for each subjects	change from baseline BPD after 1 month
Abdominal circumference (AC)	We measured AC monthly using 2D ultrasonography (USG) for each subjects	change from baseline AC after 1 month
Femur length (FL)	We measured FL monthly using 2D ultrasonography (USG) for each subjects	change from baseline FL after 1 month
Birth weight	Birth weight of the baby	immediately after the baby is born
Birth length	Birth length of the baby	immediately after the baby is born

Collaborators and Investigators

• Sponsor: Gadjah Mada University
• Collaborators: Indonesia-MoH
• Investigators: Principal Investigator: Eugenius P Ganap, PhD, Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): December 2, 2019
• Study Completion (Actual): December 2, 2019

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; protein supplementation; snakehead fish cookies; intrauterine fetal growth; low birth weight
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: Snakehead fish cookies

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This research was supported by Ministry of Health of Indonesia, and all data collected in this study were subject to Indonesian Ministry of Health rights.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No