Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

NCT04265391 | Completed

• 1 other identifier: Snakehead fish cookies
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Related

Keywords

snakehead fish cookies; intrauterine fetal growth; low birth weight; randomized controlled trial; protein supplementation

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Snakehead fish cookies

EXPERIMENTAL

Subjects who were given intervention of snakehead fish cookies during the study period

Dietary Supplement: cookies

Standard cookies

PLACEBO COMPARATOR

Subjects who were in control group and received standard cookies

Dietary Supplement: cookies

Interventions

cookies DIETARY_SUPPLEMENT

Either snakehead fish cookies or standard cookies were given to subjects 75g per day.

Snakehead fish cookies; Standard cookies

Eligibility Criteria

• Age: Up to 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• suffering from anemia,
• experiencing preeclampsia,
• having multiple gestational, and
• allergic to fish, eggs, and chocolate.

Sponsors & Collaborators

• Gadjah Mada University: lead
• Indonesia-MoH: collaborator

Study Sites (1)

Public Health Center (Puskesmas) in the area of Sleman District

Sleman, Special Region of Yogyakarta, Indonesia

Location

Study Officials

• Eugenius P Ganap, PhD

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 11, 2020
• Study Start: July 3, 2019
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)