Fish Consumption and Dietary Diversity in Timor-Leste

NCT ID: NCT04729829

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Dietary Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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FAD + SBC

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.

Group Type ACTIVE_COMPARATOR

Social and behaviour change communication

Intervention Type BEHAVIORAL

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.

Fish aggregating device

Intervention Type OTHER

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.

FAD only

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

Group Type ACTIVE_COMPARATOR

Fish aggregating device

Intervention Type OTHER

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.

SBC only

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

Group Type ACTIVE_COMPARATOR

Social and behaviour change communication

Intervention Type BEHAVIORAL

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.

Control

Control (No FAD or SBC)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Social and behaviour change communication

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 BEHAVIORAL

Fish aggregating device

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.

Intervention Type OTHER

Other Intervention Names

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FAD

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mercy Corps

OTHER

Sponsor Role collaborator

WorldFish

OTHER

Sponsor Role lead

Responsible Party

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Alex Tilley

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Tilley, PhD

Role: PRINCIPAL_INVESTIGATOR

WorldFish

Locations

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WorldFish Timor-Leste

Dili, , Timor-Leste

Site Status

Countries

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Timor-Leste

References

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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.

Reference Type DERIVED
PMID: 35802640 (View on PubMed)

Other Identifiers

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FSSP2_RCT1

Identifier Type: -

Identifier Source: org_study_id

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