Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909525333350 Date of Approval: 18/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Women empowerment through childcare
Official scientific title Feasibility, acceptability and effect of provision of childcare services at the workplace: A quasi-experimental study of women’s economic empowerment in Ruaraka sub-County, Nairobi
Brief summary describing the background and objectives of the trial Worldwide, there is a wide gap between what women can contribute to the economy and what they actually contribute. The main barrier to women’s engagement in the labor market and productivity at work is the fact that they have to take care of their families in addition to meeting the demands of their employment. Evidence from Western settings demonstrates significant benefits of interventions such as the provision of childcare services to optimize women’s participation in the labor market, as well as improve their incomes and child welfare. The objective of the proposed study is to assess the feasibility and acceptability of providing quality childcare centers in the workplace and the direct effects on women’s economic empowerment as well as indirect effects (if any) on child growth and development.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Economic empowerment
Anticipated trial start date 30/08/2019
Actual trial start date
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 291
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group childcare as an intervention for working mothers Daily for the intervention group - childcare space set up 15 months The proposed intervention will involve establishing childcare spaces within or near SMLEs in Ruaraka sub-County. We envisage that the childcare spaces will be established through collaboration between the SMLEs, project partners, and the researchers. The SMLEs selected to participate in the intervention arm will provide space within their premises or if this is not available, recommend an appropriate place close to the business premise where childcare centers will be established. As part of the of the intervention, parents will be given monthly parent training talks, on topics including basic caregiving, early childhood development, and how to improve interactions with their young children. 145
Control Group Parent training Monthly 15 months Monthly trainings 145 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The criteria for selection of the two SMLEs will be that they are located within Ruaraka sub-County Employ a significant number of women from neighboring low-income settings Have a labor force of least 50% women, Have been in existence for at least three years. All women working in the selected enterprises with children aged three months to three years, are employed as fulltime formal wage laborers at the selected workplaces and are willing to consent for the study will be eligible to participate. Women with children above three years Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/09/2019 AMREF Ethics Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
P.O Box 27691 Nairobi 00506 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome- changes in women’s labor force participation, autonomy, number of hours that they work per week, their household income, time allocated to household tasks and prospects for career advancement. Endline
Secondary Outcome Child developmental outcomes Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ruaraka Ruaraka industrial park Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Echidna giving fund 915-2 BATTERY ST., SUITE 3 SAN FRANCISCO, CA 94111 San Francisco United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African Population and Health Research Center P. O. Box 10787 Nairobi 00100 Kenya NGO
COLLABORATORS
Name Street address City Postal code Country
Kidogo Innovations Limited Adams Arcade Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Patricia Wekulo pwekulo@aphrc.org +2540204001000 African Population Research Center
City Postal code Country Position/Affiliation
Nairobi Kenya Associate Research Scientist
Role Name Email Phone Street address
Public Enquiries Ruth Muendo rmuendo@aphrc.org +2540204001000 African Population and Health Research Center
City Postal code Country Position/Affiliation
Nairobi Kenya Research Officer
Role Name Email Phone Street address
Scientific Enquiries Patricia Wekulo pwekulo@aphrc.org +2540204001000 African Population and Health Research Center
City Postal code Country Position/Affiliation
Nairobi Kenya Associate Research Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results obtained through this study will be made available to participants in the study (caregivers, participating) and key governmental and nongovernmental stakeholders in Nairobi County and nationally. • The study team will conduct two dissemination workshops. One workshop will be held with the Nairobi City County Health Management Team, the sub-County Health Management Team(s), ECD representatives from the Ministry of Education, and other stakeholders within the county. The second workshop will held in Nairobi to share research findings with government staff, development partners, NGOs, activists, media houses, health professional societies, and policymakers; • Findings of the study will be shared with researchers and policy makers at local and international conferences; • We also expect to publish articles in Open Access peer-reviewed scientific journals; • The Policy Engagement and Communication (PEC) Division at the APHRC will also use the findings of this study to produce policy briefs, fact sheets, and working papers, as well as newsletters, which will be shared with a wide range of stakeholders; • The findings of the study will also be shared through partner websites Informed Consent Form Within 12 months of completion of the study Document will be uploaded
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information