Dietary DeficiencyNCT04729829
Fish Consumption and Dietary Diversity in Timor-Leste
A study testing Social and behaviour change communication and Fish aggregating device in people with Dietary Deficiency, run by WorldFish at 1 site in Timor-Leste.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dietary Deficiency
- What is being tested?
- Social and behaviour change communication and Fish aggregating device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteTimor-Leste
- Study dates
- 15 May 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The individual's household is situated in a village included in the study, within a 30km radius of a coastal treatment site.
Who cannot join
- The individual's household is not situated in a village included in the study.
Trial locations and contacts
1 site in 1 country.
Timor-Leste1 site
WorldFish Timor-Leste
Dili
About this study
Official title: 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.
Read the 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.
- Conditions
- Dietary Deficiency
- Being tested
- Social and behaviour change communication, Fish aggregating device
- Keywords
- fish, fish aggregating device, malnutrition, micronutrient deficiency, fisheries
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social and behaviour change communicationBehavioural
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 deviceOther
Also called FAD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Behavioral: Social and behaviour change communication |
| Control | No intervention | Control (No FAD or SBC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Frequency of fish consumed at household level
measured as the number of days fish were consumed out of the previous seven days.
Measured: 1 year
Secondary outcomes (2)
Frequency of fish consumption in women
measured as the number of days fish were consumed out of the previous seven days.
Measured: 1 year
Frequency of fish consumption in children
measured as the number of days fish were consumed out of the previous seven days.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start15 May 2021
- Primary completion19 Sep 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dietary DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- WorldFish
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy Corps
- Responsible party
- Principal investigator, Alex Tilley, WorldFish
- Investigators
- Alexander Tilley, PhD, Principal investigator, WorldFish
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729829
- Sponsor's protocol ID
- FSSP2_RCT1
- Status last verified
- Aug 2024
- First submitted
- 25 Jan 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Tilley A, Byrd KA, Altarturi H, Bonis-Profumo G, Dos Reis Lopes J, Gomes M, Klumpyan K, Longobardi L, Shikuku KM. A supply and demand intervention increased fish consumption among rural women: A randomized, controlled trial. PLoS One. 2026 Feb 19;21(2):e0340861. doi: 10.1371/journal.pone.0340861. eCollection 2026.
PubMed 41712656Tilley 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.
PubMed 35802640
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Test the Effects of Fish Aggregating Devices and SBC Activities Promoting Fish Consumption in Timor-Leste
- ClinicalTrials.gov ID
- NCT04729829
- Acronym / sponsor ID
- FSSP2_RCT1
- Conditions
- Dietary Deficiency
- Keywords
- fish, fish aggregating device, malnutrition, micronutrient deficiency, fisheries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- WorldFishUniversity, hospital or other
- Collaborators
- Mercy Corps
- Study start
- 15 May 2021 (actual)
- Primary completion
- 19 Sep 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FAD + SBC | Active comparator | Behavioral: Social and behaviour change communication, Other: Fish aggregating deviceCommunity 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. |
| FAD only | Active comparator | Other: Fish aggregating deviceCommunity will be exposed to increased availability of fish from a fish aggregating device only |
| SBC only | Active comparator | Behavioral: Social and behaviour change communicationCommunity will receive information and messaging as part of a social and behaviour change communication about consuming fish. |
| Control | No intervention | –Control (No FAD or SBC) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The individual's household is situated in a village included in the study, within a 30km radius of a coastal treatment site.
Key exclusion criteria (1 listed)
- The individual's household is not situated in a village included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social and behaviour change communicationEach 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. | Behavioural | FAD + SBC, SBC only |
| Fish aggregating deviceAlso: FADThis 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 | FAD + SBC, FAD only |
Primary outcome
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.
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.
2 secondary outcomes
Frequency of fish consumption in women
Time frame: 1 year
Frequency of fish consumption in children
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 41712656Tilley A, Byrd KA, Altarturi H, Bonis-Profumo G, Dos Reis Lopes J, Gomes M, Klumpyan K, Longobardi L, Shikuku KM. A supply and demand intervention increased fish consumption among rural women: A randomized, controlled trial. PLoS One. 2026 Feb 19;21(2):e0340861. doi: 10.1371/journal.pone.0340861. eCollection 2026.
- Derived from this study: PubMed 35802640Tilley 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Tilley, PhD principal investigator
WorldFish
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social and behaviour change communication and Fish aggregating device in people with Dietary Deficiency, run by WorldFish at 1 site in Timor-Leste.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Timor-Leste. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per capita household fish consumption (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04729829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.