Impacts of Clean Cookstoves and Empowerment Training on Women's Health in Refugee Settings

August 9, 2022 updated by: Johns Hopkins Bloomberg School of Public Health

Impacts of Clean Cookstoves/Efficient Fuels Uptake and Empowerment Trainings on Women's Health and Well Being in Humanitarian Settings in Rwanda

The main objective of this study is to understand the links and outcomes of adoption of a cleaner cookstove/fuel and exposure to a personal empowerment training on women's health outcomes in a Congolese refugee camp in Rwanda, with a focus on gender-based violence (GBV).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled trial examines the impacts of a phased-in integrated technology -behavior change intervention on women's health with a focus on gender-based violence. In a population of approximately 1500 Congolese households in Kigeme refugee camp in Rwanda, two interventions are randomly deployed in the camp. The first intervention is the Inyenyeri cookstove/pellet fuel system, a Tier 4 clean cookstove system; the second intervention is a behavior change intervention (referred to as I-ACT, Individual-Agency-Centered Training) designed to foster personal agency and empowerment, given to women and, if applicable, their male partner. Analyses will be done with interviews on 1500 women (ages 18-45) from these households that may have received one, both or none of the interventions, either as the full sample or the sub-sample of partnered-only women.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1555

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
    • Kigali
      • Kacyiru, Kigali, Rwanda, KG 546ST1
        • Plan International, Rwanda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Study participants are between the ages of 18 years - 45 years of age
  • Reported as currently living in a refugee camp with no intention to relocate
  • Has lived in any refugee camp for at least 1 year and can be interviewed in private
  • Has the ability to give informed consent

Exclusion Criteria:

  • Inability to provide informed consent
  • Individuals having evidence of significant illness and/or are not able to engage fully in the surveys
  • Women younger than 18 or over 45 years of age
  • Those who have not lived continuously in a refugee camp setting for the past 12 months
  • If two or more women live in a household, only one of these will be included in the study. The one responsible for fuel purchase/collection will be selected. If more than one woman is responsible for fuel collection, we will randomly choose one woman to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Inyenyeri clean cookstove/fuel
A tier 4 clean Mimi-moto cookstove/pellet system
Device: Inyenyeri clean cookstove and fuel system
The Inyenyeri cooking systems includes a tier 4 clean cooking system with biomass pellets that are purchased through the unconditional cash transfer program in the refugee camp
EXPERIMENTAL: I-ACT behavioral empowerment intervention
A culturally adapted 2-day personal empowerment workshop (based on the Individual, Agency-Centered Training (I-ACT) to women and modified, condensed 1-day training for their male partners, if applicable
Behavioral: I-ACT (Individual, Agency-Centered Training) workshop
The I-ACT (Individual, Agency-Centered Training) empowerment workshop consists of behavioral exercises drawn primarily from positive psychology, that provide the tools to foster a growth mindset by allowing participants to understand the link between their thoughts, beliefs, and past actions to their future actions. Conducted in a workshop setting, this locally adapted version of the I-ACT curriculum consists of two days for women and a 1 day workshop for their male partners (as applicable)
EXPERIMENTAL: Cookstove and I-ACT empowerment
Access to both the clean cookstove system and I-ACT empowerment training
Device: Inyenyeri clean cookstove and fuel system
The Inyenyeri cooking systems includes a tier 4 clean cooking system with biomass pellets that are purchased through the unconditional cash transfer program in the refugee camp
Behavioral: I-ACT (Individual, Agency-Centered Training) workshop
The I-ACT (Individual, Agency-Centered Training) empowerment workshop consists of behavioral exercises drawn primarily from positive psychology, that provide the tools to foster a growth mindset by allowing participants to understand the link between their thoughts, beliefs, and past actions to their future actions. Conducted in a workshop setting, this locally adapted version of the I-ACT curriculum consists of two days for women and a 1 day workshop for their male partners (as applicable)
OTHER: I-ACT Waitlisted control
These households include those that were offered cookstoves after 6 months (from baseline) and are waitlisted to receive the I-ACT intervention
Device: Inyenyeri clean cookstove and fuel system
The Inyenyeri cooking systems includes a tier 4 clean cooking system with biomass pellets that are purchased through the unconditional cash transfer program in the refugee camp

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of gender-based violence
Time Frame: 6 months
Change in gender-based violence (GBV) over time as assessed through an adapted ASIST-GBV screening tool to identify physical violence, sexual violence, harassment, emotional violence and reproductive coercion between non-partners and intimate partners in humanitarian settings.
6 months
Number of households reporting uptake and consistent use of clean cooking system and fuel
Time Frame: 6 months
Change in uptake and use of the clean cooking system as measured through pellet purchase and reported pellet use behavior
6 months
Number of participants reporting minor psychiatric disorders
Time Frame: 6 months
Changes in the number of participants reporting minor psychiatric disorders as determined by the General Health Questionnaire (GHQ-12) as a result of the empowerment intervention.
6 months
Number of participants reporting anxiety and depression
Time Frame: 6 months
Changes in the number of participants reporting anxiety and depression as determined by the Hopkins Symptom Checklist (HSCL) as a result of the empowerment intervention.
6 months
Number of participants reporting emotional symptoms of trauma
Time Frame: 6 months
Changes in the number of participants reporting emotional symptoms of trauma as determined by the Harvard Trauma Questionnaire (HTQ) as a result of the empowerment intervention.
6 months
Number of participants reporting increased economic and social empowerment
Time Frame: 6 months
Change in rates of reported uptake of economic activities (such as small businesses or savings) as well as participation in social groups and local training programs
6 months
Number of participants reporting reduced food insecurity
Time Frame: 6 months
Change in reported incidence and severity of food insecurity as determined through a culturally adapted modification of the food insecurity experience scale (FIES) associated with food-related distress during the past month
6 months
Number of participants reporting increased self-efficacy
Time Frame: 6 months
Changes in self-efficacy (as assessed by the New General Self-Efficacy Scale) as a result of the empowerment intervention.
6 months
Number of participants reporting increased grit
Time Frame: 6 months
Changes in grit (Grit scale (Duckworth, et al)) as a result of the empowerment intervention.
6 months
Number of participants reporting increased social agency
Time Frame: 6 months
Changes in social agency (as assessed by Ryff's psychological well-being scales) as a result of the empowerment intervention.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants reporting increased quality and quantity of social networks
Time Frame: 6 months
Changes in quality of social networks in the form of network size, network density and stove homophily resulting from either the empowerment training or the improved cookstove program as determined by reported social ties and characteristics of those social ties.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Bank
Fundacion Plan International Espana
Global Alliance for Clean Cookstoves

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anita V Shankar, Ph.D., Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Naira Kalra, Ph.D., Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data from this sample on social networks will be shared with colleagues at Boston College

IPD Sharing Time Frame

August 2019-January 2020

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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