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Samaki Salama: Small-scale Fisheries for Healthy Nutrition and Ecosystems

Primary Purpose

Malnutrition, Child, Growth; Stunting, Nutritional

Status
Active
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Social marketing
social marketing + gear modification
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition, Child focused on measuring Social marketing, Fish, Animal source food, Complementary feeding, Sustainable fishing

Eligibility Criteria

6 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Pwani University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group 1: Control

Group 2: Social Marketing

Group 3: Social Marketing + Gear Modification

Arm Description

No activities will take place in group 1.

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

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.

Outcomes

Primary Outcome Measures

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 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 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 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).

Secondary Outcome Measures

Child Dietary Diversity
Dietary intakes will be measured using Kenya-specific semi-quantitative food frequency questionnaire (FFQ). A comprehensive list of foods consumed in Kenya, and specifically along the coast, will be compiled along with ingredients in common dishes. This will be integrated into the survey as an FFQ for 24-hr intakes of youth and children ages 6-60 months. Findings from the FFQ will later be converted to the Feed the Future (FTF) indicators of minimum dietary diversity. Finally, infant and young child feeding practices (IYCF) practices will be assessed in accordance with the FTF minimum acceptable diet indicator.
Child Diarrheal Morbidity
Measured using mothers' reporting of acute diarrhea (3 or more liquid or semi-liquid stools in a 24-hour period over the last two weeks).
Fisheries Earnings
Data on fisher operational costs and revenue generation will be collected using surveys. Questions will be informed by cultural norms and objects such as food and equipment used as currency when Kenyan Shillings cannot be estimated (e.g. bags of rice).

Full Information

First Posted
June 15, 2021
Last Updated
February 14, 2022
Sponsor
Washington University School of Medicine
Collaborators
University of Rhode Island, Pwani University, Egerton University
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1. Study Identification

Unique Protocol Identification Number
NCT05254444
Brief Title
Samaki Salama: Small-scale Fisheries for Healthy Nutrition and Ecosystems
Official Title
Samaki Salama: Securing Small-scale Fisheries in Kenya for Healthy Nutrition and Ecosystems
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Rhode Island, Pwani University, Egerton University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
One in five young children globally suffer the consequences of stunted growth and development, while millions experience deficiencies in zinc, iron, iodine, vitamins A and B12, nutrients found bioavailable in fish foods. Small-scale fisheries (SSF) have the potential to generate wealth and augment fish consumption while being environmentally sustainable if appropriate systems are in place. However, those engaged in SSF are often marginalized by large industrial fisheries and other factors. Coastal communities in Kenya are dominated by SSF and are among the poorest and most malnourished globally. To address these critical issues, investigators aim to test the effectiveness of a bundled intervention to address malnutrition and its intersections with nutrition security and fisheries sustainability. A matched intervention/control study will be conducted to examine the multifaceted Samaki Salama ("fish security" in Kiswahili) intervention in Kilifi, Kenya. The matched communities will be divided into three groups: (1) control; (2) multi-tiered nutrition social marketing intervention to fishers, mothers, and health workers; (3) multi-tiered nutrition social marketing intervention plus fisher gear modification and training. A total of 8 communities will be matched based on based on location (rural), livelihoods and child nutritional status into control (n=4) and intervention (n=4) groups. Participants from 400 small-scale fisher households will be recruited and enrolled by Kenyan partners from Egerton University and Pwani University using the eligibility criteria. Group 1 (n=200 households) will be the control group. Group 2 (n=100 households) will receive a multi-tiered nutrition social marketing intervention focused on promoting dietary diversity and fish food consumption specifically among infants, young children and women of reproductive age. The nutrition intervention will target fishers, mother and health workers and involve monthly communications of key nutrition messages across a range of platforms including mobile phone messaging through WhatsApp or SMS, social media, radio, t-shirts, stickers, flyers, cooking classes, meetings of mother's groups and other convening opportunities. Group 3 (n=100 households) will receive a bundled intervention of the multi-tiered nutrition social marketing intervention plus fisher gear modification and training. Fishers from Group 3 will receive modified fishing gear (traps) designed specifically to improve harvest efficiency and promote sustainable fish populations. Training on modified gear use will be administered through local fishing cooperatives. Investigators hypothesize that the combined impact of the targeted social marketing and fisher trap interventions will improve the diet, health and nutritional status of children as well increase fisheries yield and fisher's earnings in intervention communities. Specific hypotheses of primary and secondary outcomes are as follows: Hypotheses: primary outcomes The children in the intervention groups (combined groups 2 and 3) with have increased height-for-age Z score (HAZ) by 0.20 compared to children in the control (group 1). The children in the intervention groups (combined groups 2 and 3) with have increased weight-for-age Z score (WAZ) by 0.10 compared to children in the control (group 1). The children in the intervention groups (combined groups 2 and 3) with have increased fish food intakes by 100 g compared to children in the control (group 1). Fishers in the group 3 will have significantly increased fisheries yields of mature fish compared to fishers in the control (group 1). Hypotheses: secondary outcomes The children in the intervention groups (combined 2 and 3) with have increased dietary diversity by 1.2 compared to children in the control (group 1). The children in the intervention groups (combined 2 and 3) with have reduced diarrheal morbidity by 5 percentage points compared to children in the control (group 1). Fishers in group 3 will have significantly increased earnings compared to fishers in the control (group 1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child, Growth; Stunting, Nutritional
Keywords
Social marketing, Fish, Animal source food, Complementary feeding, Sustainable fishing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Control
Arm Type
No Intervention
Arm Description
No activities will take place in group 1.
Arm Title
Group 2: Social Marketing
Arm Type
Experimental
Arm Description
Households in this arm will receive a multi-tiered social marketing campaign focusing on sustainable fish nutrition, dietary diversity and food safety.
Arm Title
Group 3: Social Marketing + Gear Modification
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social marketing
Intervention Description
Multi-tiered nutrition social marketing intervention focused on sustainable fish nutrition, dietary diversity and food safety.
Intervention Type
Behavioral
Intervention Name(s)
social marketing + gear modification
Intervention Description
Multi-tiered nutrition social marketing intervention plus fishing gear modification (basket trap) and training.
Primary Outcome Measure Information:
Title
Change in child weight
Description
Child weight in kilograms. A weight-for-age Z score (WAZ), a measure of underweight, will be calculated using weight and date of birth.
Time Frame
Change from baseline weight-for-age (WAZ) at 12 months
Title
Change in child height
Description
Child height in centimeters. A height-for-age Z score (HAZ), a measure of stunting, using height and date of birth
Time Frame
Change from baseline height-for-age (HAZ) at 12 months
Title
Change in child fish foods intake
Description
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.
Time Frame
Change from baseline fish foods intake at 12 months
Title
Change in fisheries yield
Description
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).
Time Frame
Change from baseline fisheries yield at 12 months
Secondary Outcome Measure Information:
Title
Child Dietary Diversity
Description
Dietary intakes will be measured using Kenya-specific semi-quantitative food frequency questionnaire (FFQ). A comprehensive list of foods consumed in Kenya, and specifically along the coast, will be compiled along with ingredients in common dishes. This will be integrated into the survey as an FFQ for 24-hr intakes of youth and children ages 6-60 months. Findings from the FFQ will later be converted to the Feed the Future (FTF) indicators of minimum dietary diversity. Finally, infant and young child feeding practices (IYCF) practices will be assessed in accordance with the FTF minimum acceptable diet indicator.
Time Frame
Baseline and months 6 and 12
Title
Child Diarrheal Morbidity
Description
Measured using mothers' reporting of acute diarrhea (3 or more liquid or semi-liquid stools in a 24-hour period over the last two weeks).
Time Frame
Baseline and months 6 and 12
Title
Fisheries Earnings
Description
Data on fisher operational costs and revenue generation will be collected using surveys. Questions will be informed by cultural norms and objects such as food and equipment used as currency when Kenyan Shillings cannot be estimated (e.g. bags of rice).
Time Frame
Baseline, regular intervals (5-10 times per month) for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora Iannotti, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pwani University
City
Kilifi
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
2 years from the completion of primary endpoints.
IPD Sharing Access Criteria
Researchers wanting to use the data would have to contact the PIs and explain their purpose for using the data.
Citations:
PubMed Identifier
36339158
Citation
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.
Results Reference
derived

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Samaki Salama: Small-scale Fisheries for Healthy Nutrition and Ecosystems

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