Preterm DeliveryNCT02694679
Randomized Controlled Trial of Social Network Targeting in Honduras
A study testing CBNH in people with Preterm Delivery and Hypothermia, run by Yale University at 2 sites in 2 countries.
Trial summary
Social network targeting strategies can be used to improve the delivery and uptake of health interventions. We will enroll approximately 30,000 individuals into a randomized controlled trial of different targeting algorithms in order to explore how social network dynamics affect the uptake, diffusion, and group-level… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery, Hypothermia, Diarrhea
- What is being tested?
- CBNH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31,195 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2015to Jan 2020
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: People who live or work in target villages, ages 12 and up -
Exclusion Criteria: People who do not live or work in the sample villages, and those who are prisoners, mentally impaired, or under age 12 years.
-
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Yale Institute for Network Science
New Haven, Connecticut, 06520
About this study
Official title: Randomized Controlled Trial of Social Network Targeting to Magnify Population-Level MNCH Behavior Change in Honduras
Social network targeting strategies can be used to improve the delivery and uptake of health interventions. We will enroll approximately 30,000 individuals into a randomized controlled trial of different targeting algorithms in order to explore how social network dynamics affect the uptake, diffusion, and group-level normative reinforcement of key neonatal and infant health behaviors and attitudes in 176 rural villages in the Copan region of Honduras. Our goal is to develop methods by which global health practitioners can exploit face-to-face social network interactions in order to maximize uptake of neonatal and infant health interventions. The villages will be randomly assigned to 16 cells of 11 villages each in a 2 x 8 factorial design of different targeting algorithms.
Read the detailed description
Honduras has one of the highest neonatal mortality rates in Latin America despite having made significant strides in reducing neonatal, infant, and child mortality in the last several decades. Although many neonatal and infant deaths can be prevented through provision of clinical care services, emerging evidence also suggests that a substantial reduction in neonatal and infant mortality can also be achieved with simple, low-cost interventions within family and community settings. This is particularly important in areas where functional community health facilities are not available. Family and community outreach programs can serve to educate families about beneficial home care practices.
In order to accelerate neonatal mortality reduction , there is an urgent need to develop innovative solutions that are not only effective, but also more easily implementable and more readily scalable. An important component of this challenge, which has hitherto not been effectively measured and understood with respect to neonatal mortality, is the "embeddedness" of individuals within social networks. Hence, through a large-scale randomized controlled trial (RCT) in rural Honduras, we will deploy and assess social network targeting algorithms in order to maximize diffusion and adoption of the "Changing behaviors to improve neonatal, child, and maternal health using communication and social networks at the community level intervention (CBNH)". The CBNH intervention is a household-level intervention package that targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management implemented by the Inter-American Development Bank (IADB) and their partners.
This RCT is aimed at discerning optimal methods for targeting delivery of the intervention to the population. Specifically we will (1) test what percentage of a community needs to be in a program to achieve social norms change around key neonatal care behaviors, and (2) test whether so-called nominated-friend-targeting, a method that targets individuals who are more highly connected in the network, is more effective than a control strategy. Our 2x8 factorial design will examine how large a subset of the population should be used as a "seed" group in order to maximize the chances of spread of the effect, and the efficiency with which such an intervention might be delivered in the future. To do this, we will assign each of the 176 study villages to either one of the two groups: 1)random assignment (active comparator), where "seed" individuals are chose at random or 2) friend-of-random assignment (experimental), where "seed" individuals are chosen on the basis of being named as a friend of a randomly selected individual. Each of the groups of villages will also be assigned to one of eight treatment percentages (0%, 5%, 10%, 20%, 30% 50%, 75%, 100%), where each represents the percent of targeted households in that village to receive the CBNH health intervention.
- Conditions
- Preterm Delivery, Hypothermia, Diarrhea, Upper Respiratory Infection, Omphalitis
- Being tested
- CBNH
- Keywords
- social networks, maternal and child health, global health
- Medical subject headings
- Premature Birth, Hypothermia, Diarrhea, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBNHBehavioural
The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.
| Study group | Role | What they receive |
|---|---|---|
| Random 0 | No intervention | The CBNH intervention will be delivered to 0% of population targeted households in the village. |
| Random 5 | Active comparator | The CBNH intervention will be delivered to a random 5% of targeted households in the village. Receives: Behavioral: CBNH |
| Random 10 | Active comparator | The CBNH intervention will be delivered to a random 10% of targeted households in the village. Receives: Behavioral: CBNH |
| Random 20 | Active comparator | The CBNH intervention will be delivered to a random 20% of targeted households in the village. Receives: Behavioral: CBNH |
| Random 30 | Active comparator | The CBNH intervention will be delivered to a random 30% of targeted households in the village. Receives: Behavioral: CBNH |
| Random 50 | Active comparator | The CBNH intervention will be delivered to a random 50% of targeted households in the village. Receives: Behavioral: CBNH |
| Random 75 | Active comparator | The CBNH intervention will be delivered to a random 75% of targeted households in the village. Receives: Behavioral: CBNH |
| Random 100 | Active comparator | The CBNH intervention will be delivered to a random 100% of targeted households in the village. Receives: Behavioral: CBNH |
| Friendship 0 | No intervention | CBNH 0% of population targeted |
| Friendship 5 | Experimental | The CBNH intervention will be delivered to 5% of households identified through friendship nomination. Receives: Behavioral: CBNH |
| Friendship 10 | Experimental | The CBNH intervention will be delivered to 10% of households identified through friendship nomination. Receives: Behavioral: CBNH |
| Friendship 20 | Experimental | The CBNH intervention will be delivered to 20% of households identified through friendship nomination. Receives: Behavioral: CBNH |
| Friendship 30 | Experimental | The CBNH intervention will be delivered to 30% of households identified through friendship nomination. Receives: Behavioral: CBNH |
| Friendship 50 | Experimental | The CBNH intervention will be delivered to 50% of households identified through friendship nomination. Receives: Behavioral: CBNH |
| Friendship 75 | Experimental | The CBNH intervention will be delivered to 75% of households identified through friendship nomination. Receives: Behavioral: CBNH |
| Friendship 100 | Experimental | The CBNH intervention will be delivered to 100% of households identified through friendship nomination. Receives: Behavioral: CBNH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey).
Measured: 24 Months
Percent of participants reporting paternal involvement during pregnancy and postpartum care (participant survey).
Measured: 24 Months
Percent of newborns with appropriate umbilical cord care (participant survey)
Measured: 24 Months
Percent of children under 5 with diarrheal illness in the last 4 weeks (participant survey)
Measured: 24 Months
Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey).
Measured: 24 months
Percent of women experiencing a pregnancy danger sign who sought professional medical care (participant survey).
Measured: 24 months
Percent of children experiencing a newborn danger sign who were taken to professional medical care (participant survey)
Measured: 24 months
Percent of children who were breastfed exclusively during first 6 months (participant survey)
Measured: 24 Months
Percentage of deliveries taking place in medical facilities (participant survey, medical records).
Measured: 24 months
Receipt of post-natal care medical check-up within 7 days of delivery - Mother (participant survey, medical records).
Measured: 24 months
Receipt of post-natal care medical check-up within 7 days of delivery - Newborn (participant survey, medical records).
Measured: 24 months
Percent of newborns receiving appropriate thermal care during first 7 days after birth (participant survey).
Measured: 24 months
Secondary outcomes (10)
Knowledge/attitudes about thermal care in newborns (Participant survey)
Measured: 24 months
Knowledge/attitudes about paternal involvement (Participant survey)
Measured: 24 months
Knowledge/attitudes about proper cord care (Participant survey)
Measured: 24 months
Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey)
Measured: 24 months
Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey)
Measured: 24 months
Knowledge about danger signs during pregnancy (Participant survey).
Measured: 24 months
Knowledge about danger signs for newborns (Participant survey).
Measured: 24 months
Knowledge/attitudes about facility-based births (Participant survey).
Measured: 24 months
Knowledge/attitudes about post-natal care for women (Participant survey).
Measured: 24 months
Knowledge/attitudes about post-natal care for newborns (Participant survey).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2020
- Study completionJan 2020
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 Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 31,195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Inter-American Development Bank, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Nicholas Christakis, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694679
- Sponsor's protocol ID
- 1506016012
- Status last verified
- Aug 2023
- First submitted
- 24 Feb 2016
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Shakya HB, Stafford D, Hughes DA, Keegan T, Negron R, Broome J, McKnight M, Nicoll L, Nelson J, Iriarte E, Ordonez M, Airoldi E, Fowler JH, Christakis NA. Exploiting social influence to magnify population-level behaviour change in maternal and child health: study protocol for a randomised controlled trial of network targeting algorithms in rural Honduras. BMJ Open. 2017 Mar 13;7(3):e012996. doi: 10.1136/bmjopen-2016-012996.
PubMed 28289044Oles W, Alexander M, Negron R, Nelson J, Iriarte E, Airoldi EM, Christakis NA, Forastiere L. Maternal and child health intervention to promote behaviour change: a population-level cluster-randomised controlled trial in Honduras. BMJ Open. 2024 Jun 10;14(6):e060784. doi: 10.1136/bmjopen-2022-060784.
PubMed 38858139
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Social Network Targeting to Magnify Population-Level MNCH Behavior Change in Honduras
- ClinicalTrials.gov ID
- NCT02694679
- Acronym / sponsor ID
- 1506016012
- Conditions
- Preterm Delivery, Hypothermia, Diarrhea, Upper Respiratory Infection, Omphalitis
- Keywords
- social networks, maternal and child health, global health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31,195 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Inter-American Development Bank, University of California, San Diego
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 29 Feb 2016 (estimated)
- 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.
Social network targeting strategies can be used to improve the delivery and uptake of health interventions. We will enroll approximately 30,000 individuals into a randomized controlled trial of different targeting algorithms in order to explore how social network dynamics affect the uptake, diffusion, and group-level normative reinforcement of key neonatal and infant health behaviors and attitudes in 176 rural villages in the Copan region of Honduras. Our goal is to develop methods by which global health practitioners can exploit face-to-face social network interactions in order to maximize uptake of neonatal and infant health interventions. The villages will be randomly assigned to 16 cells of 11 villages each in a 2 x 8 factorial design of different targeting algorithms.
Detailed description
Honduras has one of the highest neonatal mortality rates in Latin America despite having made significant strides in reducing neonatal, infant, and child mortality in the last several decades. Although many neonatal and infant deaths can be prevented through provision of clinical care services, emerging evidence also suggests that a substantial reduction in neonatal and infant mortality can also be achieved with simple, low-cost interventions within family and community settings. This is particularly important in areas where functional community health facilities are not available. Family and community outreach programs can serve to educate families about beneficial home care practices.
In order to accelerate neonatal mortality reduction , there is an urgent need to develop innovative solutions that are not only effective, but also more easily implementable and more readily scalable. An important component of this challenge, which has hitherto not been effectively measured and understood with respect to neonatal mortality, is the "embeddedness" of individuals within social networks. Hence, through a large-scale randomized controlled trial (RCT) in rural Honduras, we will deploy and assess social network targeting algorithms in order to maximize diffusion and adoption of the "Changing behaviors to improve neonatal, child, and maternal health using communication and social networks at the community level intervention (CBNH)". The CBNH intervention is a household-level intervention package that targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management implemented by the Inter-American Development Bank (IADB) and their partners.
This RCT is aimed at discerning optimal methods for targeting delivery of the intervention to the population. Specifically we will (1) test what percentage of a community needs to be in a program to achieve social norms change around key neonatal care behaviors, and (2) test whether so-called nominated-friend-targeting, a method that targets individuals who are more highly connected in the network, is more effective than a control strategy. Our 2x8 factorial design will examine how large a subset of the population should be used as a "seed" group in order to maximize the chances of spread of the effect, and the efficiency with which such an intervention might be delivered in the future. To do this, we will assign each of the 176 study villages to either one of the two groups: 1)random assignment (active comparator), where "seed" individuals are chose at random or 2) friend-of-random assignment (experimental), where "seed" individuals are chosen on the basis of being named as a friend of a randomly selected individual. Each of the groups of villages will also be assigned to one of eight treatment percentages (0%, 5%, 10%, 20%, 30% 50%, 75%, 100%), where each represents the percent of targeted households in that village to receive the CBNH health intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Random 0 | No intervention | –The CBNH intervention will be delivered to 0% of population targeted households in the village. |
| Random 5 | Active comparator | Behavioral: CBNHThe CBNH intervention will be delivered to a random 5% of targeted households in the village. |
| Random 10 | Active comparator | Behavioral: CBNHThe CBNH intervention will be delivered to a random 10% of targeted households in the village. |
| Random 20 | Active comparator | Behavioral: CBNHThe CBNH intervention will be delivered to a random 20% of targeted households in the village. |
| Random 30 | Active comparator | Behavioral: CBNHThe CBNH intervention will be delivered to a random 30% of targeted households in the village. |
| Random 50 | Active comparator | Behavioral: CBNHThe CBNH intervention will be delivered to a random 50% of targeted households in the village. |
| Random 75 | Active comparator | Behavioral: CBNHThe CBNH intervention will be delivered to a random 75% of targeted households in the village. |
| Random 100 | Active comparator | Behavioral: CBNHThe CBNH intervention will be delivered to a random 100% of targeted households in the village. |
| Friendship 0 | No intervention | –CBNH 0% of population targeted |
| Friendship 5 | Experimental | Behavioral: CBNHThe CBNH intervention will be delivered to 5% of households identified through friendship nomination. |
| Friendship 10 | Experimental | Behavioral: CBNHThe CBNH intervention will be delivered to 10% of households identified through friendship nomination. |
| Friendship 20 | Experimental | Behavioral: CBNHThe CBNH intervention will be delivered to 20% of households identified through friendship nomination. |
| Friendship 30 | Experimental | Behavioral: CBNHThe CBNH intervention will be delivered to 30% of households identified through friendship nomination. |
| Friendship 50 | Experimental | Behavioral: CBNHThe CBNH intervention will be delivered to 50% of households identified through friendship nomination. |
| Friendship 75 | Experimental | Behavioral: CBNHThe CBNH intervention will be delivered to 75% of households identified through friendship nomination. |
| Friendship 100 | Experimental | Behavioral: CBNHThe CBNH intervention will be delivered to 100% of households identified through friendship nomination. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| CBNHThe household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management. | Behavioural | Friendship 10, Friendship 100, Friendship 20, Friendship 30, Friendship 5, Friendship 50, Friendship 75, Random 10, Random 100, Random 20, Random 30, Random 5, Random 50, Random 75 |
Primary outcome
Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey).
Time frame: 24 Months
Percent of participants reporting paternal involvement during pregnancy and postpartum care (participant survey).
Time frame: 24 Months
Percent of newborns with appropriate umbilical cord care (participant survey)
Time frame: 24 Months
Percent of children under 5 with diarrheal illness in the last 4 weeks (participant survey)
Time frame: 24 Months
Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey).
Time frame: 24 months
Percent of women experiencing a pregnancy danger sign who sought professional medical care (participant survey).
Time frame: 24 months
Percent of children experiencing a newborn danger sign who were taken to professional medical care (participant survey)
Time frame: 24 months
Percent of children who were breastfed exclusively during first 6 months (participant survey)
Time frame: 24 Months
Percentage of deliveries taking place in medical facilities (participant survey, medical records).
Time frame: 24 months
Receipt of post-natal care medical check-up within 7 days of delivery - Mother (participant survey, medical records).
Time frame: 24 months
Receipt of post-natal care medical check-up within 7 days of delivery - Newborn (participant survey, medical records).
Time frame: 24 months
Percent of newborns receiving appropriate thermal care during first 7 days after birth (participant survey).
Time frame: 24 months
10 secondary outcomes
Knowledge/attitudes about thermal care in newborns (Participant survey)
Time frame: 24 months
Knowledge/attitudes about paternal involvement (Participant survey)
Time frame: 24 months
Knowledge/attitudes about proper cord care (Participant survey)
Time frame: 24 months
Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey)
Time frame: 24 months
Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey)
Time frame: 24 months
Knowledge about danger signs during pregnancy (Participant survey).
Time frame: 24 months
Knowledge about danger signs for newborns (Participant survey).
Time frame: 24 months
Knowledge/attitudes about facility-based births (Participant survey).
Time frame: 24 months
Knowledge/attitudes about post-natal care for women (Participant survey).
Time frame: 24 months
Knowledge/attitudes about post-natal care for newborns (Participant survey).
Time frame: 24 months
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 8 Aug 2023.
- Background: PubMed 28289044Shakya HB, Stafford D, Hughes DA, Keegan T, Negron R, Broome J, McKnight M, Nicoll L, Nelson J, Iriarte E, Ordonez M, Airoldi E, Fowler JH, Christakis NA. Exploiting social influence to magnify population-level behaviour change in maternal and child health: study protocol for a randomised controlled trial of network targeting algorithms in rural Honduras. BMJ Open. 2017 Mar 13;7(3):e012996. doi: 10.1136/bmjopen-2016-012996.
- Derived from this study: PubMed 38858139Oles W, Alexander M, Negron R, Nelson J, Iriarte E, Airoldi EM, Christakis NA, Forastiere L. Maternal and child health intervention to promote behaviour change: a population-level cluster-randomised controlled trial in Honduras. BMJ Open. 2024 Jun 10;14(6):e060784. doi: 10.1136/bmjopen-2022-060784.
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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.
Nicholas Christakis, MD, PhD principal investigator
Yale University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBNH in people with Preterm Delivery and Hypothermia, run by Yale University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Honduras. 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?
Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey). (time frame: 24 Months). The study lists 12 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 NCT02694679, 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 8 Aug 2023.