- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03376152
Rural China Electric Kettle Promotion Program
Rural China Electric Kettle Promotion Program: a Cluster-Randomized Controlled Trial of Pilot Program Impact on Electric Kettle Adoption, Drinking Water Quality, Indoor Air Pollution, and Reported Health Outcomes in Poverty Households in the People's Republic of China
Study Overview
Status
Intervention / Treatment
Detailed Description
Previous research suggests that increasing the use of electric kettles for boiling (i.e., treating) drinking water in low-income areas of rural China could help expand access to safer drinking water, reduce household air pollution, and improve environmental and health outcomes in rural Chinese households currently boiling drinking water with solid-fuels (or not treating their water, or drinking contaminated bottled water).
The study will use a parallel arm cohort cluster-randomized controlled trial design with a 1:1 ratio. The study will randomize 30 clusters (i.e., villages) to treatment or control using stratified randomization by geography (two levels: mountains and plains) and by cluster proportions of reported electric kettle use at baseline. Randomization sequence generation will be conducted by A. Cohen using a random number generator (with a reproducible seed) in Stata v.13.1 (StataCorp, College Station, Texas, USA).
The study will collect data from 30 randomly selected households in 15 villages, for a total of 900 households. This sample size was powered to measure a 15% (or larger) change in electric kettle adoption, because the Chinese Center for Disease Control and Prevention (China CDC) will be unlikely to rollout a national program if adoption rates are less than 15%.
After baseline data collection and randomized allocation, in the intervention group village-level promotion events will take place in November-December of 2017, and will be organized by the provincial and county China CDC, in collaboration with the National Center for Rural Water Supply Technical Guidance (NCRWSTG). At these promotion events, households in the intervention group will be provided free, food-grade quality, electric kettles, as well as promotional materials (a calendar and poster) and information about the benefits of electric kettle use and improved hygiene and sanitation practices.
Because of known issues with decreasing adoption of drinking water treatment after behavior change promotion interventions such as this, and considering expected seasonal variation in boiling practices and frequencies, study data was initially planned to be collected over a period of 12 months (with additional qualitative follow-up via focus groups: 2019-03, 2019-08).
We were able to extend the follow-up data collection period from 12-months to 24-months, so we did not collect data from focus groups in 2019-03 or 2019-08 as originally planned. Follow-up data collection was completed in November 2019.
Due to the COVID-19 pandemic, we again postponed plans to collect data from focus groups (data cleaning efforts were delayed until 2021, and completed at the end of 2022). Logistics allowing, we hope to collect data from focus groups in 2023.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Beijing, China
- National Center for Rural Water Supply Technical Guidance,Chinese Center for Disease Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Persons aged 18 or older will be eligible to provide consent for their households.
- Government classified "poverty households" (poverty classification based on 2016 data/records).
Exclusion Criteria:
- Persons aged 17 or younger will not be eligible to provide consent for their households.
- We will not have any exclusion criterion based on gender, race, ethnicity, language, or literacy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment Arm
"Poverty households" invited to attend cluster-level electric kettle promotion events and offered free kettles, information, and promotional materials 450 households in 15 clusters (30 households per cluster)
|
Provision of free electric kettles and promotional materials/information
|
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No Intervention: Control Arm
450 households in 15 clusters (30 households per cluster)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in proportion of households using electric kettles for boiling drinking water
Time Frame: 24 months.
|
Primary measurement via electricity use meters (Tepsung model 10/16A) affixed to electric kettle power cables for all household who report using electric kettles at each of five visits (based on total KWh consumed per data collection intervals and estimated mean liters boiled per person, per day, per household, by electric kettle type/size).
Additional measurement via self-report of electric kettle use (household surveys) and via enumerator direct observations (during visits to households).
|
24 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thermotolerant coliforms in household point-of-consumption drinking water
Time Frame: 6 months.
|
Point-of-consumption drinking water sample collection from subsample of households (150 in each arm, 300 total) and laboratory analysis via multiple tube fermentation (using China CDC national standards and protocol) for Thermotolerant coliforms, an indicator of fecal contamination.
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6 months.
|
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Diarrhea prevalence
Time Frame: 24 months.
|
Self-report (current, 7-day recall, 14-day recall)
|
24 months.
|
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Particulate matter 2.5 mg/m3 (PM2.5) concentrations
Time Frame: 1 month.
|
Custom-built air pollution sensors (PM2.5 and other - developed by Prof. Tao Shu et al. at Peking University, Beijing, CHINA) installed to collect indoor air pollution data for 3-4 weeks in a subsample of households (40-50 in each arm, 80-100 total), with 3-5 external air pollution sensors installed in each cluster to control for ambient air pollution.
|
1 month.
|
|
Prevalence of hand washing with soap
Time Frame: 24 months.
|
Self-report during household surveys combined with enumerator direct observations
|
24 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cough prevalence
Time Frame: 24 months.
|
Self-report (current, 7-day recall)
|
24 months.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yong Tao, Director, National Center for Rural Water Supply Technical Guidance
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016119356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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