NCT01672580

Brief Summary

This project will examine the spread of health interventions with a randomized control trial design by introducing public health interventions in 32 villages in the Honduran Department of Lempira. Based on identified public health needs in the region, namely improved drinking water and diet, this study will provide training on the use of chlorine (sodium hypochlorite) for water purification and multivitamins for nutritional supplementation. In some villages, individuals selected for their social connectedness will be trained and given coupons that can be redeemed for either chlorine bleach or multivitamins, and these persons will be asked to spread this information and distribute coupons to four people of their choosing. In other villages, individuals selected at random will receive the same training, materials, and instructions. A second wave of coupon distribution will provide coupons to those who received a coupon from the original "seed" groups so that they may disperse these coupons further out in the social networks. Over the following months, study investigators will look at how knowledge of these health practices, and uptake or and adherence to the practices, spreads throughout the villages. More specifically, the investigators will examine the speed and extent of spreading of these new health practices after introducing them to three different initial "seed" groups: (1) people chosen on the basis of being named as a friend by many people in their village, (2) people chosen based on being named as a friend by a randomly chosen individual, and (3) a group of randomly chosen individuals. It is hypothesized that spread will occur faster and/or to a greater extent when the intervention is started in groups 1 and 2 versus group 3 (control group).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,773

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

August 20, 2012

Last Update Submit

March 18, 2015

Conditions

Keywords

social networksnutritionvitaminschlorine

Outcome Measures

Primary Outcomes (1)

  • Intervention Spread

    Use of health product among community members will be tracked.

    October 2012

Study Arms (6)

Random-Cloro

ACTIVE COMPARATOR

exposure to water chlorination

Behavioral: exposure to water chlorination

Random-Vitamin

ACTIVE COMPARATOR

exposure to vitamin use

Behavioral: exposure to vitamin use

Indegree-Cloro

EXPERIMENTAL

high in-degree, exposure to water chlorination

Behavioral: exposure to water chlorinationBehavioral: high in-degree

Indegree-Vitamin

EXPERIMENTAL

high in-degree, exposure to vitamin use

Behavioral: exposure to vitamin useBehavioral: high in-degree

Nominated-Cloro

EXPERIMENTAL

nominated by random, exposure to water chlorination

Behavioral: exposure to water chlorinationBehavioral: nominated by random

Nominated-Vitamin

EXPERIMENTAL

nominated by random, exposure to vitamin use

Behavioral: exposure to vitamin useBehavioral: nominated by random

Interventions

"Seed" individuals in village are given daily adult multivitamin, with training on use and general nutrition information, along with coupons to distribute to others in village

Also known as: Medox Forte
Indegree-VitaminNominated-VitaminRandom-Vitamin

"Seed" individuals in village are given Clorox bleach for water purification, with training on use and general information on water hygiene, along with coupons to distribute to others in village

Also known as: Clorox
Indegree-CloroNominated-CloroRandom-Cloro
high in-degreeBEHAVIORAL

"Seed" individuals for starting intervention are chosen on the basis of high (social network) in-degree

Indegree-CloroIndegree-Vitamin

"Seed" individuals for starting intervention are chosen on the basis of being named as a friend/alter of a randomly selected individual

Nominated-CloroNominated-Vitamin

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents of Targeted Communities, ages 15 and up

You may not qualify if:

  • Children younger than age 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06517, United States

Location

Related Publications (1)

  • Kim DA, Hwong AR, Stafford D, Hughes DA, O'Malley AJ, Fowler JH, Christakis NA. Social network targeting to maximise population behaviour change: a cluster randomised controlled trial. Lancet. 2015 Jul 11;386(9989):145-53. doi: 10.1016/S0140-6736(15)60095-2. Epub 2015 May 4.

MeSH Terms

Conditions

MalnutritionDysentery

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Hypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium Compounds

Study Officials

  • Nicholas A Christakis, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR
  • Thomas Keegan, PhD

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 27, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations