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临床试验/NCT05254444
NCT05254444Unknown不适用

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

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2021年7月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,200
试验地点
1
主要终点
Change in child weight

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in child weight

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

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

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

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

时间窗: Change from baseline fish foods intake at 12 months

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

时间窗: Change from baseline fisheries yield at 12 months

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).

次要结局

  • Child Dietary Diversity(Baseline and months 6 and 12)
  • Fisheries Earnings(Baseline, regular intervals (5-10 times per month) for 12 months)
  • Child Diarrheal Morbidity(Baseline and months 6 and 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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