Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ISRCTN |
Last refreshed on:
|
18 October 2021 |
Main ID: |
ISRCTN64692465 |
Date of registration:
|
21/12/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Implementation of a baby-friendly workplace support initiative and assessment of its feasibility and success in improving mother and child nutrition and health
|
Scientific title:
|
Evidence-based implementation of baby-friendly workplace support initiative and evaluation of its potential feasibility and effectiveness on improving maternal and child nutrition and health |
Date of first enrolment:
|
19/09/2016 |
Target sample size:
|
1000 |
Recruitment status: |
Completed |
URL:
|
https://www.isrctn.com/ISRCTN64692465 |
Study type:
|
Interventional |
Study design:
|
Interventional single-center study that will use an evidence-based mixed method approach combining effectiveness-implementation hybrid trials and participatory action research methods (Quality of life)
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Kenya
| | | | | | | |
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
Elizabeth
Kimani-Murage |
Address:
|
APHRC Campus
Kirawa Road
Off Peponi Road
PO Box 10787
00100
Nairobi
Kenya |
Telephone:
|
+254 (0)20 2720400/1/2; +254 (0)20 4001000 |
Email:
|
ekimani@aphrc.org |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. The primary participants are women of reproductive age (12-49) who are employees of a tea farm in Kericho County, Kenya, and their children aged less than one year 2. Other participants include their employers including managers at the tea farm, male employees and other community members including fathers, and grandmothers (of the children), community leaders, health care workers, policy and decision makers
Exclusion criteria: The intervention/trial will not exclude anyone. However, the research will exclude eligible participants who have physical or intellectual impairment that could hinder clear communication e.g. deaf or dumb participants
Age minimum:
Age maximum:
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Nutrition and childcare Nutritional, Metabolic, Endocrine
|
Intervention(s)
|
The intervention aims to provide an enabling environment for mothers, working in a tea plantation in Kenya, to combine breastfeeding and work. The implementation design will be refined after a baseline formative study (qualitative, quantitative and participatory data collection) that will be conducted before the intervention begins. All pregnant women in the study community will be identified and recruited by peer educators at the community level before the beginning of the intervention. These women will be followed up after birth till the end of the implementation period. The implementation will be guided by the Baby-Friendly Community Initiative (BFCI) and the workplace support guidelines launched by the Ministry of Health (MoH) in 2015 and a bill of parliament passed in April 2016 that mandates employers to provide a breastfeeding friendly workplace through providing time, space and support for breastfeeding working mothers. The actual implementation design will be refined after the baseline formative study that will be conducted at the beginning of the project before the implementation of the intervention begins.
The implementation phase will be for 12 months, this period will be adequate to have an effect on the duration of exclusive breastfeeding, and its potential effect on other outcomes including work participation and productivity and nutritional and health outcomes of the infants.
During the implementation phase, all pregnant women recruited during the pre-implementation phase will be followed up for the period of the implementation phase (12 months). During midline, qualitative and quantitative assessments will be conducted. Additionally, innovative participatory methods will be used to document changes and
|
Primary Outcome(s)
|
Duration of exclusive breastfeeding, measured using surveys at baseline and end-line using 24 hour recall
|
Secondary Outcome(s)
|
1. Nutritional status of infants, determined using anthropometric measurements (height and weight, mid-upper arm circumference) at baseline and endline. It will also be collected from postpartum women (recruited at baseline while pregnant to be part of a cohort) within the 1st month post-delivery and thereafter monthly during the implementation period. 2. Breastfeeding practices, including continued breastfeeding with complementary feeding, measured at baseline and endline. It will also be collected from postpartum women (recruited at baseline while pregnant to be part of a cohort) within the 1st month post-delivery and thereafter monthly during the implementation period. 3. Morbidity of children using 14 days recall, measured at baseline and endline from all mothers with children under 1 year. It will also be collected from the cohort follow-up women (pregnant women recruited at baseline) within the 1st month post-delivery and thereafter monthly during the implementation period. 4. Work participation and productivity of women working in tea plantations, assessed using a presenteeism and absenteeism scoring method at baseline and endline using a mixed method approach (qualitative and quantitative methods). Qualitatively the trialists will seek to answer questions regarding current workplace conditions and the perceived effects on health, wellbeing, work participation and productivity of the workers. In addition, process evaluation during the implementation phase will be conducted. This will be through observations for changes in community workplace conditions and support, references to guidelines, using checklists, and obtaining monthly records on work participation and productivity for breastfeeding women. At mid-term, in-depth interviews and focus group discussions will be conducted with women and men on their experiences with community workplace support and their satisfaction and potential areas of improvement. 5. Cost effectiveness of the intervention from the employer and societal perspectives: 5.1. The return on investment, considering the costs to the business of implementing the intervention and using the data captured in the surveys (at baseline, mid and endline) on worker absenteeism and productivity. Average differences in productivity and days in work will be estimated. The effects of changes in the labour force such as retention of high performing staff, maintenance of a skilled workforce, improved morale and hence motivation and reputation benefit will be estimated from the quantitative interviews. Healthcare utilization will also be accounted for as this is provided by the employer. 5.2. The health cost-effectiveness of the intervention in terms of a cost per DALY (Disability Adjusted Life Years). Healthcare costs and utilization and the DALYs associated with the observed change in breastfeeding rates will be identified from the literature.
|
Secondary ID(s)
|
HCS/2016/0095
|
Source(s) of Monetary Support
|
UNICEF
|
Ethics review
|
Status:
Approval date:
Contact:
AMREF Ethical Scientific and Research Committee, 19/05/2016, ref: P231_2016
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
30/09/2018 |
URL:
|
|
|
|