Clinical trial NCT03376152: Rural China Electric Kettle Promotion Program
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Compliant Behavior
Diarrheal Disease
Pollution; Exposure
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: National Center for Rural Water Supply Technical Guidance (NCRWSTG), China
name: Centers for Disease Control and Prevention, China
First posted: 2017-12-18
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the impact of a pilot Rural Electric Kettle Promotion Program offered to low-income households in rural Anhui Province, China. The primary objective of this study is to determine whether this promotion program causes poverty households currently boiling their drinking water with solid-fuels (or drinking untreated water or bottled water) to switch to boiling their drinking water with electric kettles, and if so, how such a switch might improve safe drinking water access and/or reduce household air pollution.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in proportion of households using electric kettles for boiling drinking water
timeFrame: 24 months.
Secondary outcomes:
measure: Thermotolerant coliforms in household point-of-consumption drinking water
timeFrame: 6 months.
measure: Diarrhea prevalence
timeFrame: 24 months.
measure: Particulate matter 2.5 mg/m3 (PM2.5) concentrations
timeFrame: 1 month.
measure: Prevalence of hand washing with soap
timeFrame: 24 months.
Other outcomes:
measure: Cough prevalence
timeFrame: 24 months.
Locations:
city: Beijing
country: China
facility: National Center for Rural Water Supply Technical Guidance，Chinese Center for Disease Control and Prevention
Study officials:
affiliation: National Center for Rural Water Supply Technical Guidance
name: Yong Tao, Director
role: PRINCIPAL_INVESTIGATOR
References: