Fish Consumption and Dietary Diversity in Timor-Leste

A Randomised Controlled Trial to Test the Effects of Fish Aggregating Devices and SBC Activities Promoting Fish Consumption in Timor-Leste

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.

Study Overview

• Status: Recruiting
• Conditions: Dietary Deficiency
• Intervention / Treatment: Behavioral: Social and behaviour change communication; Other: Fish aggregating device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Joctan Dos Reis Lopes, BSc; Phone Number: +67078124024; Email: j.dosreislopes@cgiar.org
• Study Contact Backup: Name: Mario Pereira, BSc; Email: m.pereira@cgiar.org

Study Locations

• Timor-Leste
  • Dili, Timor-Leste
    • Recruiting
    • WorldFish Timor-Leste
    • Contact: Alexander Tilley, PhD; Phone Number: +447449162317; Email: a.tilley@cgiar.org
    • Contact: Mario Pereira, BSc; Phone Number: +67077851358; Email: m.pereira@cgiar.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.; Other: 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.; Other Names: FAD
Active Comparator: FAD only; Community will be exposed to increased availability of fish from a fish aggregating device only	Other: 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.; Other Names: FAD
Active Comparator: SBC only; Community will receive information and messaging as part of a social and behaviour change communication about consuming fish.	Behavioral: 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.
No Intervention: Control; Control (No FAD or SBC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of fish consumption in women	measured as the number of days fish were consumed out of the previous seven days.	1 year
Frequency of fish consumption in children	measured as the number of days fish were consumed out of the previous seven days.	1 year

Collaborators and Investigators

• Sponsor: WorldFish
• Collaborators: Mercy Corps
• Investigators: Principal Investigator: Alexander Tilley, PhD, WorldFish

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): September 19, 2021
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: malnutrition; fish; fish aggregating device; micronutrient deficiency; fisheries
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: FSSP2_RCT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No