Fish Consumption and Dietary Diversity in Timor-Leste

August 26, 2024 updated by: Alex Tilley, WorldFish

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
720

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Per capita household fish consumption
Time Frame: 1 year
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
Time Frame: 1 year
measured as the number of days fish were consumed out of the previous seven days.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of fish consumption in women
Time Frame: 1 year
measured as the number of days fish were consumed out of the previous seven days.
1 year
Frequency of fish consumption in children
Time Frame: 1 year
measured as the number of days fish were consumed out of the previous seven days.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
WorldFish

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mercy Corps

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexander Tilley, PhD, WorldFish

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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