Malnutrition, ChildNCT05254444
Samaki Salama: Small-scale Fisheries for Healthy Nutrition and Ecosystems
A study testing Social marketing and social marketing + gear modification in people with Malnutrition, Child and Growth; Stunting, Nutritional, run by Washington University School of Medicine at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child, Growth; Stunting, Nutritional
- What is being tested?
- Social marketing and social marketing + gear modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteKenya
- Study dates
- 9 Jul 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Samaki Salama: Securing Small-scale Fisheries in Kenya for Healthy Nutrition and Ecosystems
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.
Read the 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).
- Conditions
- Malnutrition, Child, Growth; Stunting, Nutritional
- Being tested
- Social marketing, social marketing + gear modification
- Keywords
- Social marketing, Fish, Animal source food, Complementary feeding, Sustainable fishing
- Medical subject headings
- Child Nutrition Disorders, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social marketingBehavioural
Multi-tiered nutrition social marketing intervention focused on sustainable fish nutrition, dietary diversity and food safety.
social marketing + gear modificationBehavioural
Multi-tiered nutrition social marketing intervention plus fishing gear modification (basket trap) and training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: social marketing + gear modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: Change from baseline fisheries yield at 12 months
Secondary outcomes (3)
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.
Measured: Baseline and months 6 and 12
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).
Measured: Baseline and months 6 and 12
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).
Measured: Baseline, regular intervals (5-10 times per month) for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start9 Jul 2021
- Primary completionNov 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island, Pwani University, Egerton University
- Responsible party
- Sponsor
- Investigators
- Lora Iannotti, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254444
- Sponsor's protocol ID
- 7200AA18CA00030
- Status last verified
- Feb 2022
- First submitted
- 15 Jun 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36339158
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samaki Salama: Securing Small-scale Fisheries in Kenya for Healthy Nutrition and Ecosystems
- ClinicalTrials.gov ID
- NCT05254444
- Acronym / sponsor ID
- 7200AA18CA00030
- Conditions
- Malnutrition, Child, Growth; Stunting, Nutritional
- Keywords
- Social marketing, Fish, Animal source food, Complementary feeding, Sustainable fishing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Rhode Island, Pwani University, Egerton University
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control | No intervention | –No activities will take place in group 1. |
| Group 2: Social Marketing | Experimental | Behavioral: Social marketingHouseholds in this arm will receive a multi-tiered social marketing campaign focusing on sustainable fish nutrition, dietary diversity and food safety. |
| Group 3: Social Marketing + Gear Modification | Experimental | Behavioral: social marketing + gear modificationHouseholds 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. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social marketingMulti-tiered nutrition social marketing intervention focused on sustainable fish nutrition, dietary diversity and food safety. | Behavioural | Group 2: Social Marketing |
| social marketing + gear modificationMulti-tiered nutrition social marketing intervention plus fishing gear modification (basket trap) and training. | Behavioural | Group 3: Social Marketing + Gear Modification |
Primary outcome
Change in child weight
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
3 secondary outcomes
Child Dietary Diversity
Time frame: Baseline and months 6 and 12
Child Diarrheal Morbidity
Time frame: Baseline and months 6 and 12
Fisheries Earnings
Time frame: Baseline, regular intervals (5-10 times per month) for 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 36339158Blackmore 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora Iannotti, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social marketing and social marketing + gear modification in people with Malnutrition, Child and Growth; Stunting, Nutritional, run by Washington University School of Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child weight (time frame: Change from baseline weight-for-age (WAZ) at 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.