NCT02694679

Brief 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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

4.6 years

First QC Date

February 24, 2016

Last Update Submit

August 4, 2023

Conditions

Preterm DeliveryHypothermiaDiarrheaUpper Respiratory InfectionOmphalitis

Keywords

social networks, maternal and child health, global health

Outcome Measures

Primary Outcomes (12)

  • Speed of adoption of intervention and fraction of adoption of CBNH intervention (participant survey).

    24 Months

  • Percent of participants reporting paternal involvement during pregnancy and postpartum care (participant survey).

    24 Months

  • Percent of newborns with appropriate umbilical cord care (participant survey)

    24 Months

  • Percent of children under 5 with diarrheal illness in the last 4 weeks (participant survey)

    24 Months

  • Percent of children under age 5 with symptoms of acute respiratory illness in the last 4 weeks (participant survey).

    24 months

  • Percent of women experiencing a pregnancy danger sign who sought professional medical care (participant survey).

    24 months

  • Percent of children experiencing a newborn danger sign who were taken to professional medical care (participant survey)

    24 months

  • Percent of children who were breastfed exclusively during first 6 months (participant survey)

    24 Months

  • Percentage of deliveries taking place in medical facilities (participant survey, medical records).

    24 months

  • Receipt of post-natal care medical check-up within 7 days of delivery - Mother (participant survey, medical records).

    24 months

  • Receipt of post-natal care medical check-up within 7 days of delivery - Newborn (participant survey, medical records).

    24 months

  • Percent of newborns receiving appropriate thermal care during first 7 days after birth (participant survey).

    24 months

Secondary Outcomes (10)

  • Knowledge/attitudes about thermal care in newborns (Participant survey)

    24 months

  • Knowledge/attitudes about paternal involvement (Participant survey)

    24 months

  • Knowledge/attitudes about proper cord care (Participant survey)

    24 months

  • Knowledge/attitudes about prevention and/or treatment of diarrhea (Participant survey)

    24 months

  • Knowledge/attitudes about prevention and/or treatment of respiratory illness (Participant survey)

    24 months

  • +5 more secondary outcomes

Study Arms (16)

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.

Behavioral: CBNH

Random 10

ACTIVE COMPARATOR

The CBNH intervention will be delivered to a random 10% of targeted households in the village.

Behavioral: CBNH

Random 20

ACTIVE COMPARATOR

The CBNH intervention will be delivered to a random 20% of targeted households in the village.

Behavioral: CBNH

Random 30

ACTIVE COMPARATOR

The CBNH intervention will be delivered to a random 30% of targeted households in the village.

Behavioral: CBNH

Random 50

ACTIVE COMPARATOR

The CBNH intervention will be delivered to a random 50% of targeted households in the village.

Behavioral: CBNH

Random 75

ACTIVE COMPARATOR

The CBNH intervention will be delivered to a random 75% of targeted households in the village.

Behavioral: CBNH

Random 100

ACTIVE COMPARATOR

The CBNH intervention will be delivered to a random 100% of targeted households in the village.

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.

Behavioral: CBNH

Friendship 10

EXPERIMENTAL

The CBNH intervention will be delivered to 10% of households identified through friendship nomination.

Behavioral: CBNH

Friendship 20

EXPERIMENTAL

The CBNH intervention will be delivered to 20% of households identified through friendship nomination.

Behavioral: CBNH

Friendship 30

EXPERIMENTAL

The CBNH intervention will be delivered to 30% of households identified through friendship nomination.

Behavioral: CBNH

Friendship 50

EXPERIMENTAL

The CBNH intervention will be delivered to 50% of households identified through friendship nomination.

Behavioral: CBNH

Friendship 75

EXPERIMENTAL

The CBNH intervention will be delivered to 75% of households identified through friendship nomination.

Behavioral: CBNH

Friendship 100

EXPERIMENTAL

The CBNH intervention will be delivered to 100% of households identified through friendship nomination.

Behavioral: CBNH

Interventions

CBNHBEHAVIORAL

The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.

Friendship 10Friendship 100Friendship 20Friendship 30Friendship 5Friendship 50Friendship 75Random 10Random 100Random 20Random 30Random 5Random 50Random 75

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale Institute for Network Science

New Haven, Connecticut, 06520, United States

Location

Community intervention

Copán, Copán Department, Honduras

Location

Related Publications (2)

  • 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.

    PMID: 28289044BACKGROUND

  • Oles 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.

    PMID: 38858139DERIVED

MeSH Terms

Conditions

Premature BirthHypothermiaDiarrheaRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveInfectionsRespiratory Tract Diseases

Study Officials

  • Nicholas Christakis, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

February 29, 2016

Study Start

June 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations

HO(1)US(1)