Clinical trial NCT05254444: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition, Child
Growth; Stunting, Nutritional
Keywords: Social marketing
Fish
Animal source food
Complementary feeding
Sustainable fishing
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
name: Pwani University
name: Egerton University
First posted: 2022-02-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change in child weight
timeFrame: Change from baseline weight-for-age (WAZ) at 12 months
measure: Change in child height
timeFrame: Change from baseline height-for-age (HAZ) at 12 months
measure: Change in child fish foods intake
timeFrame: Change from baseline fish foods intake at 12 months
measure: Change in fisheries yield
timeFrame: Change from baseline fisheries yield at 12 months
Secondary outcomes:
measure: Child Dietary Diversity
timeFrame: Baseline and months 6 and 12
measure: Child Diarrheal Morbidity
timeFrame: Baseline and months 6 and 12
measure: Fisheries Earnings
timeFrame: Baseline, regular intervals (5-10 times per month) for 12 months
Other outcomes:
Locations:
city: Kilifi
country: Kenya
facility: Pwani University
Study officials:
affiliation: Washington University School of Medicine
name: Lora Iannotti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.