Pilot study in rural setting in Kenya to determine whether the baby friendly community initiative (BFCI) will work

• Register: ISRCTN
• Last refreshed on: 3 February 2020
• Main ID: ISRCTN03467700
• Date of registration: 24/09/2014
• Prospective Registration: Yes
• Primary sponsor: National Academy of Sciences (NAS) (USA)
• Public title: Pilot study in rural setting in Kenya to determine whether the baby friendly community initiative (BFCI) will work
• Scientific title: Feasibility and effectiveness of the baby friendly community initiative in Kenya: a pilot community trial in a rural setting
• Date of first enrolment: 01/11/2014
• Target sample size: 800
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN03467700
• Study type: Interventional
• Study design: Prospective cluster randomized controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Kenya

Contacts

• Name: Judith Kimiywe

Key inclusion & exclusion criteria

Inclusion criteria:
1. Pregnant women who consent to participate in the study
2. Aged between 15 - 49 years old in Koibatek sub-county, Baringo County, Kenya

Exclusion criteria:
1. Women of reproductive age who will have given birth before receiving at least one counselling session particularly regarding exclusive breastfeeding.
2. Women who lose the pregnancy and/or have a still-birth
3. Women who are lost to follow-up during pregnancy
4. Mother-child pairs of children with a disability that makes delivery of the intervention difficult e.g. hearing or sight problem, or mental handicap


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Nutrition
Nutritional, Metabolic, Endocrine

Intervention(s)

The intervention will involve personalized, home-based counselling and support of pregnant and lactating women on maternal, infant and young child nutrition and also counselling and support by healthcare professionals at basic health facilities in the community. Pregnant women in the treatment group will be visited by community health workers on a regular basis throughout pregnancy and until the child is 6 months old. During these visits, the women will be given one-on-one counselling on their own nutrition and also on proper breastfeeding and infant and young child feeding practices. Additionally, pregnant women in the treatment group will receive information materials regarding maternal, infant and young child nutrition. Health professionals in the facilities in the intervention community units will be sensitized on the baby friendly community initiative so to counsel and support mothers effectively. Further, mother support groups involving mothers will be formed under which mothers will educate and support each other on breastfeeding and other child care practices.

Pregnant women in the control group will receive standard care that will involve visits by community health workers and counselling on general health including antenatal and postnatal care, necessary tests during pregnancy and the importance of health facility delivery. They will also receive information materials on maternal and child nutrition.

Joint/scientific contact details:
co-PI: Dr Elizabeth Kimani; [e-mail]

Primary Outcome(s)

The primary outcome measure is the proportion of exclusive breastfeeding for the first 6 months. This will involve determining the impact of the BFCI intervention on the level or proportion of exclusive breastfeeding for the first 6 months. Data on breastfeeding practices will be collected longitudinally from birth every 2 months through an interviewer-administered questionnaire to the mother (24-hour recall at 2, 4, 6 months) with probes on the age at introduction of foods or liquids (if appropriate). Analyses will focus on the differences between the two study arms in the proportion of infants being exclusively breastfed at 6 months, as well as at the two earlier times of 2 and 4 months postpartum.

Secondary Outcome(s)

Qualitative
1. Norms and cultural factors that influence breastfeeding and other maternal, infant and young child feeding practices. Data will be collected through qualitative interviews with mothers, fathers, community leaders, TBAs, community health workers, other community members, and healthcare providers.
2. Enabling factors and barriers. Data will be collected through qualitative interviews with mothers, fathers, community leaders, TBAs, community health workers, other community members, and healthcare providers to identify key players and structures in the community that would facilitate implementation of BFCI; factors that influence uptake of interventions in the community; and any potential hindrances to the success of the intervention (e.g., myths, beliefs)

Quantitative
3. MIYCN knowledge, attitudes and practices according to WHO recommendations. Data will be collected through self-reports by mothers using an interviewer-administered questionnaire at recruitment and every 2 months during the follow-up period to determine change in knowledge, attitudes and practices with the intervention.
4. Timing of initiation of breastfeeding. Data will be collected through self-reports by mothers using an interviewer-administered questionnaire within the first 2 months of birth.
5. Nutritional status: stunting, underweight, wasting within the first 6 months. This will be done through anthropometric measurements (weight, height and mid-upper arm circumference) every 2 months after birth till 6 months.
6. Diarrhea morbidity: evidence indicates that breastfeeding is preventive against infections such as rotaviral diarrhea. It is therefore expected that promotion of exclusive breastfeeding would impact on the rate of diarrhea morbidity. Data on diarrhea morbidity in the last 2 weeks for the child will be collected longitudinally through an interviewer-administered questionnaire to the mother every 2 months.
7. Satisfaction with the intervention, facilitating and limiting factors. Data will be collected through a self-administered questionnaire to the mother. Additionally, qualitative interviews will be conducted with the mothers and community members including community health workers on experiences with the intervention.

Secondary ID(s)

N/A

Source(s) of Monetary Support

National Institutes of Health (NIH) (USA), United States Agency for International Development (USAID) (USA), Through the Partnership for Enhanced Engagement in Research (PEER) Health Program, through the National Academies of Science (NAS) (USA)

Ethics review

Status:
Approval date:
Contact:

Kenya Medical Research Institute, 04/08/2014, Reference: KEMRI/RES/7/3/1 - NON - SSC protocol No. 443

Results

• Results available: Yes
• Date Completed: 30/06/2016