MalnutritionNCT01672580
Social Network Interventions in Rural Honduras
A study testing exposure to vitamin use, exposure to water chlorination and high in-degree in people with Malnutrition and Dysentery, run by Harvard University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Dysentery, Social Transmission of Health Behaviors
- What is being tested?
- exposure to vitamin use, exposure to water chlorination and high in-degree
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,773 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2014
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents of Targeted Communities, ages 15 and up
Who cannot join
- Children younger than age 15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diffusion of Health Interventions Across Social Networks in Honduran Villages
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).
- Being tested
- exposure to vitamin use, exposure to water chlorination, high in-degree, nominated by random
- Keywords
- social networks, nutrition, vitamins, chlorine
- Medical subject headings
- Malnutrition, Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to vitamin useBehavioural
Also called Medox Forte
"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 chlorinationBehavioural
Also called Clorox
"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-degreeBehavioural
"Seed" individuals for starting intervention are chosen on the basis of high (social network) in-degree
nominated by randomBehavioural
"Seed" individuals for starting intervention are chosen on the basis of being named as a friend/alter of a randomly selected individual
| Study group | Role | What they receive |
|---|---|---|
| Random-Cloro | Active comparator | exposure to water chlorination Receives: Behavioral: exposure to water chlorination |
| Random-Vitamin | Active comparator | exposure to vitamin use Receives: Behavioral: exposure to vitamin use |
| Indegree-Cloro | Experimental | high in-degree, exposure to water chlorination Receives: Behavioral: exposure to water chlorination; Behavioral: high in-degree |
| Indegree-Vitamin | Experimental | high in-degree, exposure to vitamin use Receives: Behavioral: exposure to vitamin use; Behavioral: high in-degree |
| Nominated-Cloro | Experimental | nominated by random, exposure to water chlorination Receives: Behavioral: exposure to water chlorination; Behavioral: nominated by random |
| Nominated-Vitamin | Experimental | nominated by random, exposure to vitamin use Receives: Behavioral: exposure to vitamin use; Behavioral: nominated by random |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Spread
Use of health product among community members will be tracked.
Measured: October 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Thomas Keegan, Ph.D., Yale University
- Investigators
- Nicholas A Christakis, MD, PhD, Principal investigator, Yale UniversityThomas Keegan, PhD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672580
- Sponsor's protocol ID
- Lempira_Phase2
- Status last verified
- Mar 2015
- First submitted
- 20 Aug 2012
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25952354
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion of Health Interventions Across Social Networks in Honduran Villages
- ClinicalTrials.gov ID
- NCT01672580
- Acronym / sponsor ID
- Lempira_Phase2
- Keywords
- social networks, nutrition, vitamins, chlorine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,773 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- Aug 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Aug 2012 (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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Random-Cloro | Active comparator | Behavioral: exposure to water chlorinationexposure to water chlorination |
| Random-Vitamin | Active comparator | Behavioral: exposure to vitamin useexposure to vitamin use |
| Indegree-Cloro | Experimental | Behavioral: exposure to water chlorination, Behavioral: high in-degreehigh in-degree, exposure to water chlorination |
| Indegree-Vitamin | Experimental | Behavioral: exposure to vitamin use, Behavioral: high in-degreehigh in-degree, exposure to vitamin use |
| Nominated-Cloro | Experimental | Behavioral: exposure to water chlorination, Behavioral: nominated by randomnominated by random, exposure to water chlorination |
| Nominated-Vitamin | Experimental | Behavioral: exposure to vitamin use, Behavioral: nominated by randomnominated by random, exposure to vitamin use |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents of Targeted Communities, ages 15 and up
Key exclusion criteria (1 listed)
- Children younger than age 15
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 |
|---|---|---|
| exposure to vitamin useAlso: Medox Forte"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 | Behavioural | Indegree-Vitamin, Nominated-Vitamin, Random-Vitamin |
| exposure to water chlorinationAlso: Clorox"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 | Behavioural | Indegree-Cloro, Nominated-Cloro, Random-Cloro |
| high in-degree"Seed" individuals for starting intervention are chosen on the basis of high (social network) in-degree | Behavioural | Indegree-Cloro, Indegree-Vitamin |
| 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 | Behavioural | Nominated-Cloro, Nominated-Vitamin |
Primary outcome
Intervention Spread
Time frame: October 2012
Use of health product among community members will be tracked.
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 19 Mar 2015.
- Derived from this study: PubMed 25952354Kim 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.
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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 A Christakis, MD, PhD principal investigator
Yale University
Thomas Keegan, PhD study director
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exposure to vitamin use, exposure to water chlorination and high in-degree in people with Malnutrition and Dysentery, run by Harvard University at 1 site in United States.
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 19 Mar 2015. 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 United States. 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?
Intervention Spread (time frame: October 2012). 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 NCT01672580, which also lists 1 linked publication.
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 19 Mar 2015.