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Fish Consumption and Dietary Diversity in Timor-Leste

Primary Purpose

Dietary Deficiency

Status
Unknown status
Phase
Early Phase 1
Locations
Timor-Leste
Study Type
Interventional
Intervention
Social and behaviour change communication
Fish aggregating device
Sponsored by
WorldFish
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dietary Deficiency focused on measuring fish, fish aggregating device, malnutrition, micronutrient deficiency, fisheries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The individual's household is situated in a village included in the study, within a 30km radius of a coastal treatment site.

Exclusion Criteria:

  • The individual's household is not situated in a village included in the study.

Sites / Locations

  • WorldFish Timor-LesteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

FAD + SBC

FAD only

SBC only

Control

Arm Description

Community will be exposed to increased availability of fish from a fish aggregating device and will receive information and messaging as part of a social and behaviour change communication about consuming fish.

Community will be exposed to increased availability of fish from a fish aggregating device only

Community will receive information and messaging as part of a social and behaviour change communication about consuming fish.

Control (No FAD or SBC)

Outcomes

Primary Outcome Measures

Per capita household fish consumption
measured as total quantity (g) of fish consumed by the household in the previous seven days divided by the number adult equivalents in the household.
Frequency of fish consumed at household level
measured as the number of days fish were consumed out of the previous seven days.

Secondary Outcome Measures

Frequency of fish consumption in women
measured as the number of days fish were consumed out of the previous seven days.
Frequency of fish consumption in children
measured as the number of days fish were consumed out of the previous seven days.

Full Information

First Posted
January 25, 2021
Last Updated
October 12, 2021
Sponsor
WorldFish
Collaborators
Mercy Corps
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1. Study Identification

Unique Protocol Identification Number
NCT04729829
Brief Title
Fish Consumption and Dietary Diversity in Timor-Leste
Official Title
A Randomised Controlled Trial to Test the Effects of Fish Aggregating Devices and SBC Activities Promoting Fish Consumption in Timor-Leste
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
September 19, 2021 (Actual)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
WorldFish
Collaborators
Mercy Corps

4. Oversight

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

5. Study Description

Brief Summary
A one-year, cluster-randomized, partially masked, controlled trial to test and compare the effects of fish aggregating devices and social and behaviour change communication on the frequency and volume of household fish consumption in upland areas of Timor-Leste.
Detailed Description
This trial is a one-year, cluster-randomized, partially masked, controlled trial among families living in rural, inland Timor-Leste. This trial aims to test and compare the effects of two treatments, alone and in combination, on the frequency and volume of household fish consumption in upland areas as a proxy for improved dietary diversity and micronutrient intake. Treatment 1 is the installation of nearshore, moored fish aggregating devices (FADs) to improve catch rates with existing fishing gears. Treatment 2 is social and behaviour change (SBC) activities to promote fish consumption. Villages in inland communities will be randomized to receive treatment 1, treatment 2, both treatments, or neither treatment. Some households with one child under five will be recruited, and data will be collected at baseline (prior to the rollout of the treatments) and endline. Our study will determine the impact of an improved supply of fish, along with nutrition-oriented SBC activities, on the fish purchasing and consumption practices of rural, inland households. Findings from this study are urgently needed by small island developing states in order to make policy and investment decisions on how best to improve households' diets using locally available, nutrient-dense foods such as fish. Investments such as these are needed to break the cycle of malnutrition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Deficiency
Keywords
fish, fish aggregating device, malnutrition, micronutrient deficiency, fisheries

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The main treatment variable is a dummy variable that indicates to which of the four treatment arms a village was assigned. Our primary model is an unadjusted model. However, if we find that after unmasking, there are variables in the dataset that appear different by treatment arm, we may consider adjusting for confounders in the model. We will first estimate a parsimonious model with only the treatment dummies and the municipality fixed effects. Then we will control for additional baseline covariates. The control group is the no-FAD and no-SBC group. Intent to treat (ITT) will be estimated separately for midline and end line subsamples. However, we will compare the magnitude of impacts at midline and endline.
Masking
Outcomes Assessor
Masking Description
Partially masked. Participation is randomised to the community level. Participants will be aware they are participating in a project/study, but not the particular study design or which treatment arm they are assigned to. Statistical analysts will be masked until the analysis is complete.
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FAD + SBC
Arm Type
Active Comparator
Arm Description
Community will be exposed to increased availability of fish from a fish aggregating device and will receive information and messaging as part of a social and behaviour change communication about consuming fish.
Arm Title
FAD only
Arm Type
Active Comparator
Arm Description
Community will be exposed to increased availability of fish from a fish aggregating device only
Arm Title
SBC only
Arm Type
Active Comparator
Arm Description
Community will receive information and messaging as part of a social and behaviour change communication about consuming fish.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control (No FAD or SBC)
Intervention Type
Behavioral
Intervention Name(s)
Social and behaviour change communication
Intervention Description
Each SBC treatment community will receive nutrition content and learning through savings groups. The group members will participate in skill-building activities that promote five key behaviours about fish nutrition and household decision making on fish consumption as part of facilitated discussions, interactive learning sessions, and a video-based facilitated dialogue. Increased fish consumption through SBC mass attendance events through marketing of fish vendors, interactive learning, and edu-tainment competitions promoting fish consumption. SBC will raise awareness of the benefits of eating fish as part of a balanced diet, with a particular focus on pregnant and lactating mothers, and children under 5 years of age.
Intervention Type
Other
Intervention Name(s)
Fish aggregating device
Other Intervention Name(s)
FAD
Intervention Description
This is a moored line attached to buoys in coastal waters that attracts oceanic fish to it, to make it easier for small-scale fishers to catch them using their existing gear and boats. This FAD will work to increase the catch rate and hence, the availability of fish for sale in upland community markets.
Primary Outcome Measure Information:
Title
Per capita household fish consumption
Description
measured as total quantity (g) of fish consumed by the household in the previous seven days divided by the number adult equivalents in the household.
Time Frame
1 year
Title
Frequency of fish consumed at household level
Description
measured as the number of days fish were consumed out of the previous seven days.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Frequency of fish consumption in women
Description
measured as the number of days fish were consumed out of the previous seven days.
Time Frame
1 year
Title
Frequency of fish consumption in children
Description
measured as the number of days fish were consumed out of the previous seven days.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The individual's household is situated in a village included in the study, within a 30km radius of a coastal treatment site. Exclusion Criteria: The individual's household is not situated in a village included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joctan Dos Reis Lopes, BSc
Phone
+67078124024
Email
j.dosreislopes@cgiar.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Pereira, BSc
Email
m.pereira@cgiar.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Tilley, PhD
Organizational Affiliation
WorldFish
Official's Role
Principal Investigator
Facility Information:
Facility Name
WorldFish Timor-Leste
City
Dili
Country
Timor-Leste
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Tilley, PhD
Phone
+447449162317
Email
a.tilley@cgiar.org
First Name & Middle Initial & Last Name & Degree
Mario Pereira, BSc
Phone
+67077851358
Email
m.pereira@cgiar.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data will be kept confidential. Data will be submitted daily via 3G for review by in-country researchers and only stored on password protected mobile phone tablets and laptops temporarily. Participants will be assigned randomly-generated ID numbers, and names and identifying information will be de-linked from the dataset. Data will be analysed for groups and no individual response will be identifiable. Survey data will be archived and accessible to only the research team and those approved by the entire research team. Anonymised datasets will be securely maintained indefinitely to facilitate future research for example pooled analysis with other studies for purposes of meta-analysis or multi-site analysis.
Citations:
PubMed Identifier
35802640
Citation
Tilley A, Byrd KA, Pincus L, Klumpyan K, Dobson K, Dos Reis Lopes J, Shikuku KM. A randomised controlled trial to test the effects of fish aggregating devices (FADs) and SBC activities promoting fish consumption in Timor-Leste: A study protocol. PLoS One. 2022 Jul 8;17(7):e0269221. doi: 10.1371/journal.pone.0269221. eCollection 2022.
Results Reference
derived

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Fish Consumption and Dietary Diversity in Timor-Leste

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