Fish Consumption and Dietary Diversity in Timor-Leste

NCT04729829 | Completed DMC

• 1 other identifier: FSSP2_RCT1
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Deficiency

Keywords

fish; fish aggregating device; malnutrition; micronutrient deficiency; fisheries

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• Frequency of fish consumed at household level

  measured as the number of days fish were consumed out of the previous seven days.

  1 year

Secondary Outcomes (2)

• Frequency of fish consumption in women

  1 year

• Frequency of fish consumption in children

  1 year

Study Arms (4)

FAD + SBC

ACTIVE COMPARATOR

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.

Behavioral: Social and behaviour change communication; Other: Fish aggregating device

FAD only

ACTIVE COMPARATOR

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

Other: Fish aggregating device

SBC only

ACTIVE COMPARATOR

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

Behavioral: Social and behaviour change communication

Control

NO INTERVENTION

Control (No FAD or SBC)

Interventions

Social and behaviour change communication 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.

FAD + SBC; SBC only

Fish aggregating device 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.

Also known as: FAD

FAD + SBC; FAD only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• WorldFish: lead
• Mercy Corps: collaborator

Study Sites (1)

WorldFish Timor-Leste

Dili, Timor-Leste

Location

Related Publications (1)

• 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.

  PMID: 35802640 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Flavin-Adenine Dinucleotide

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Riboflavin; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Pigments, Biological; Biological Factors

Study Officials

• Alexander Tilley, PhD

  WorldFish

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: May 15, 2021
• Primary Completion: September 19, 2021
• Study Completion: September 30, 2022
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TI (1)