Fish Consumption and Dietary Diversity in Timor-Leste

Dietary Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04729829
• Other study ID #: FSSP2_RCT1
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 15, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2021
• Source: WorldFish
• Contact: Joctan Dos Reis Lopes, BSc
• Phone: +67078124024
• Email: j.dosreislopes[@]cgiar.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 30, 2022
• Est. primary completion date: September 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Deficiency
• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Timor-Leste	WorldFish Timor-Leste	Dili

Sponsors (2)

Lead Sponsor	Collaborator
WorldFish	Mercy Corps

Country where clinical trial is conducted

Timor-Leste, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Frequency of fish consumption in women	measured as the number of days fish were consumed out of the previous seven days.	1 year
Secondary	Frequency of fish consumption in children	measured as the number of days fish were consumed out of the previous seven days.	1 year