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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01672580
Other study ID # Lempira_Phase2
Secondary ID
Status Completed
Phase N/A
First received August 20, 2012
Last updated March 18, 2015
Start date August 2012
Est. completion date October 2014

Study information

Verified date March 2015
Source Harvard University
Contact n/a
Is FDA regulated No
Health authority Honduras: Ministry of Health
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 5773
Est. completion date October 2014
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Residents of Targeted Communities, ages 15 and up

Exclusion Criteria:

- Children younger than age 15

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
exposure to vitamin use
"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
exposure to water chlorination
"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
high in-degree
"Seed" individuals for starting intervention are chosen on the basis of high (social network) in-degree
nominated by random
"Seed" individuals for starting intervention are chosen on the basis of being named as a friend/alter of a randomly selected individual

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Harvard University Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intervention Spread Use of health product among community members will be tracked. October 2012 No
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