NCT05254444

Brief Summary

The purpose of this study is to test the effectiveness of a bundled intervention to address malnutrition and its intersections with nutrition security and fisheries sustainability in Kilifi, Kenya.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

July 9, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

June 15, 2021

Last Update Submit

February 14, 2022

Conditions

Keywords

Social marketingFishAnimal source foodComplementary feedingSustainable fishing

Outcome Measures

Primary Outcomes (4)

  • Change in child weight

    Child weight in kilograms. A weight-for-age Z score (WAZ), a measure of underweight, will be calculated using weight and date of birth.

    Change from baseline weight-for-age (WAZ) at 12 months

  • Change in child height

    Child height in centimeters. A height-for-age Z score (HAZ), a measure of stunting, using height and date of birth

    Change from baseline height-for-age (HAZ) at 12 months

  • Change in child fish foods intake

    Intake of fish foods assessed for children 6-60 months using a Kenya-specific semi-quantitative food frequency questionnaire (FFQ) that includes both 24-hour and 7-day recalls.

    Change from baseline fish foods intake at 12 months

  • Change in fisheries yield

    Fisher's catch will be counted and weighed and identified at landing sites. Lengths of fish will be measured for a sub-sample of individuals (n=20). Monthly catch per unit effort (i.e. yield) will be calculated as the mean daily catch multiplied by the fishing days per month. Sustainable yields will be determined by comparing the initial yields versus the rate of change of yields for each landing site or Beach Management Unit (BMU).

    Change from baseline fisheries yield at 12 months

Secondary Outcomes (3)

  • Child Dietary Diversity

    Baseline and months 6 and 12

  • Child Diarrheal Morbidity

    Baseline and months 6 and 12

  • Fisheries Earnings

    Baseline, regular intervals (5-10 times per month) for 12 months

Study Arms (3)

Group 1: Control

NO INTERVENTION

No activities will take place in group 1.

Group 2: Social Marketing

EXPERIMENTAL

Households in this arm will receive a multi-tiered social marketing campaign focusing on sustainable fish nutrition, dietary diversity and food safety.

Behavioral: Social marketing

Group 3: Social Marketing + Gear Modification

EXPERIMENTAL

Households in this arm will receive a bundled intervention of the social marketing campaign as well as modified fishing gear (basket traps with fish escape gaps) and training on proper utilization and management.

Behavioral: social marketing + gear modification

Interventions

Multi-tiered nutrition social marketing intervention focused on sustainable fish nutrition, dietary diversity and food safety.

Group 2: Social Marketing

Multi-tiered nutrition social marketing intervention plus fishing gear modification (basket trap) and training.

Group 3: Social Marketing + Gear Modification

Eligibility Criteria

Age6 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • A household member works in small-scale fisheries (self-employed fishers)
  • At least one child in the household aged 6-60 months
  • At least one member of the household owns a mobile phone
  • Provision of signed and dated informed consent form
  • For children, informed assent and parental informed consent to participate in the study
  • Stated willingness to comply with all study procedures and availability for the duration of the study

You may not qualify if:

  • No household member works in small-scale fisheries (self-employed fishers)
  • No child in the household aged 6-60 months
  • No members of the household own a mobile phone
  • Declines to sign the informed consent
  • Index child is severely malnourished
  • Lives outside the study area
  • Participation in another nutrition or fisheries intervention study within April 2021 - June 2022

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pwani University

Kilifi, Kenya

Location

Related Publications (1)

  • Blackmore I, Wamukota A, Kamau-Mbuthia E, Humphries A, Lesorogol C, Cohn R, Sarange C, Mbogholi F, Obata C, Cheupe C, Cheupe J, Sherburne L, Chapnick M, Cartmill MK, Iannotti LL. Samaki Salama - Promoting healthy child growth and sustainable fisheries in coastal Kenya: A study protocol. Front Public Health. 2022 Oct 21;10:934806. doi: 10.3389/fpubh.2022.934806. eCollection 2022.

MeSH Terms

Conditions

Child Nutrition DisordersGrowth Disorders

Interventions

Social Marketing

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MarketingCommerceTechnology, Industry, and AgricultureMarketing of Health ServicesHealth Services AccessibilityDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Lora Iannotti, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

February 24, 2022

Study Start

July 9, 2021

Primary Completion

November 1, 2022

Study Completion

June 1, 2023

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Data collected for this study will be analyzed and stored on the REDCap platform and on Box, a secure, HIPAA and FERPA compliant data storage and sharing online platform. After the study is completed, the de-identified, archived data will be transmitted to the USAID Feed the Future Fish Innovation Lab for use by other researchers including those outside of the study. Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint by contacting the PI from the sponsor University.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2 years from the completion of primary endpoints.
Access Criteria
Researchers wanting to use the data would have to contact the PIs and explain their purpose for using the data.

Locations