Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201910846018049 Date of Approval: 16/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mother-to-Mother Support Groups
Official scientific title Impact of Mother-to-Mother Support Groups in Promoting Exclusive Breastfeeding in a Low-Resource Rural Community In Kenya: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Objective: To assess the impact of community-based Mother-to-Mother Support Groups (MTMSGs) with and without income generating activity (IGA) in promoting exclusive breastfeeding in low socioeconomic rural setting in Kenya. Breastfeeding is the single most effective intervention for growth, health, development and survival of infants. Exclusive breastfeeding (EBF) provides infants with optimal nutrition requirements. Studies have demonstrated a number of short-term and long-term nutrition, health and socioeconomic benefits associated with breastfeeding. EBF protects infants against illnesses such as: respiratory diseases, diarrhoea, allergies, asthma, obesity and (human immune-deficiency virus) HIV infection. Mothers who exclusively breastfeed their infants have delayed onset of menstrual periods, have less risk of breast/ovarian cancers and experience better bonding with their infants. Early initiation to breastfeeding within one hour of birth, a critical indicator of EBF, saves 22% of infants from neonatal deaths. Recently, there has been improvement in the EBF rates in Kenya from 32% to 61 % (between 2009 and 2014). However, the country still has one of the lowest EBF rates in Sub-Saharan Africa. Community-based strategies improve the rates of EBF by increasing the length of maternal support before and after delivery. MTMSG is one of the strategies promoted by UNICEF worldwide for the improvement of infant young child feeding practices. In Kenya, there is paucity of information on the role of breastfeeding MTMSGs in improving infant and young child feeding despite the fact that the Ministry of Health (MoH), Kenya and UNICEF are promoting their use. Prior to this study, there had been no scientific study, to the knowledge of the authors in investigating the impact of the MTMSGs in promoting EBF in Kenya..
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MTMSGs
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/12/2012
Actual trial start date 10/12/2012
Anticipated date of last follow up 10/06/2013
Actual Last follow-up date 10/07/2013
Anticipated target sample size (number of participants) 222
Actual target sample size (number of participants) 249
Recruitment status Completed
Publication URL http://ir-library.ku.ac.ke/handle/123456789/13516
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mother to mother support groups with breastfeeding education and support Mother to mother support groups' meetings were held with breastfeeding training/support sessions for mothers- once monthly before birth (at third trimester) and once monthly for six months after birth. 7 months Mother to mother support groups' meetings were held with breastfeeding training/support sessions (by research team staff) once before birth at third trimester; within first week of birth; and once at end of each month for sixmonths after birth. There were 5 support groups of about 15 mothers each were formed. Total number recruited was 82 members. 82
Experimental Group Mother to mother support groups with breastfeeding education and support with income activities Mother to mother support group meetings and activities carried out once monthly by each group for seven months 7months Mothers met in groups (5 groups) each of about 15 members.Total recruited was 88 members. They met one time monthly pre-natally ( at third trimester) and six times post-natally (within one week of giving birth and at end of each month for breastfeeding education and support. They also made and liquid soap as an income generating activity. 88
Control Group Control Group Mothers met once monthly, once prenatally at third trimester and 6 times post-natally 7 months Mothers attended MCH clinic once monthly pre-natally and six times post-natally (once first week of birth and then at end of each month after birth) for breastfeeding talks at MCH clinics by their local health care nurses....normally composed of random group talks on health and nutrition but with no input from the research team. No mother to mother support Groups were formed. There were 79 members in this group. 79 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mothers who were in their third trimester of pregnancy (33-37 weeks gestation) and HIV negative were included in the study. The gestation age and HIV status were determined from their mother and child health booklets and hospital records respectively. Another inclusion criterion was that one ought to have been resident in the study areas for at least six months before the study and planned to stay in the study site for at least seven months from the time of recruitment into the study. Mothers with a history of pregnancy complications such as diabetes, eclampsia, hypertension or hyperemesis based on medical records were excluded from the study. Infant: 0 Month(s)-12 Month(s) 0 Day(s) 6 Month(s) Both
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 13/12/2012 KNHUON ERC
Ethics Committee Address
Street address City Postal code Country
Kenyatta National Hospital Kenya Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  Exclusive breast-feeding on monthly basis during the first six months as determined by 24-hour recall on a monthly basis. Monthly for first 6 months
Secondary Outcome Cumulative EBF from birth at 6 months This was determined after first six Months after birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mutuati SubDistrict Hospital Mutuati, Meru County, Kenya Meru County Kenya Kenya
Antubetwe Health Centre Meru County Antubetwe, Meru County, Kenya Meru County Kenya Kenya
Kanuni Health Centre Meru County Kenya Kanuni, Meru County, kenya Meru County Kenya Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
NACOSTI National Council for Science Technlogy and Innovation Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta University Kenya 43844 Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Prof. Judith Kimiywe Kenyatta University, P.O Box 43844 00100, Nairobi, Kenya Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph MLiria mwitiliria@gmail.com +254722359925 43844
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Lecturer Kenyatta University
Role Name Email Phone Street address
Public Enquiries AN Guantai Guantai uonknh_erc@uonbi.ac.ke +2547263009 University Way
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Professor Universirty of Nairobi
Role Name Email Phone Street address
Scientific Enquiries Judith Kimiywe jokimiywe@gmail.com +2548710901 Kenyatta University, Thika Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Professor Kenyatta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results published at Kenyatta University website Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2012-1015 Free Access at Kenyatta University Library Depository
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://ir-library.ku.ac.ke/handle/123456789/13516 Yes Exclusive breast-feeding (EBF) is recognized globally as the best way of ensuring child survival, growth and development because it reduces infant morbidity, mortality and ensures better nutrition outcomes. The major challenge has been the low rates of EBF globally (36%) despite the gradual increase in EBF rates in recent years. Prevalence of EBF is 32% and 18.6% in Kenya and Igembe District the study site, respectively. Mother-to-mother support groups (MTMSGs) is a strategy used in Kenya and other countries in the promotion of EBF. There is scarcity of data on the effectiveness of MTMSGs in promotion of EBF in Kenya. The aim of this study was to assess the effectiveness of MTMSGs in promoting EBF in Igembe District, in Meru County, Kenya. The study adopted a cluster randomized controlled trial design in which 3 health centres were randomly allocated on a 1:1:1 ratio to 3 study groups; 2 treatment groups and one control group. In one treatment group (MES), the mothers in the MTMSGs received education support whereas in the second treatment group (MESIGA) the mothers were engaged in an income generating activity in addition to receiving education support. In both groups, the mothers held 7 monthly meetings, one pre-natally and six post-natally. The mothers in the control group received no education support from the research team but followed the usual standard nutrition/health education at the health centre. The sample sizes for each group were: MES 88; MESIGA 82; and the control group 79 mothers. The determination of infant feeding practices was done on a monthly basis from months 1 to 6. Observations of infant feeding practices were carried out on a10% of the study sample to verify maternal self-reported information at the interviews. Data on infant morbidity and weight measurements was collected on a monthly basis. Six focus group discussions were held to collect in-depth information on the rationale for maternal choices of infant feeding methods. The study outcome was EBF prevalence at 6 months as defined by cross-sectional data based on 24-hour recall and cumulative or continuous EBF. Data was analysed using SPSS software Version 17.0 and SAS 9.3 software. Mothers in MESIGA and MES were two times more likely to be exclusively breastfed at 6 months compared to mothers in Control Group {RR=2.42;CI(1.36-4.28);(p=0.004}and {RR=1.89; CI(1.02-3.49);(p=0.033)} respectively using cross-sectional 24-hr recall data. There was no significant difference between EBF rates at 6 months in MES and MESIGA. The median duration of cumulative EBF for the CG was significantly lower at 0.68 months as compared with MES at 2.8 months and MESIGA at 3.36 months (p=0.001). IGAs had significant (p<0.001) effect on rates of attendance to MTMSG meeting. The predictors of EBF were: not giving infants post-lacteal feeds (OR=0.17(0.05-0.55); (p=0.003)}, lack of infants’ illness {OR=0.27(0.12-0.63); (p=0.002) and receiving breastfeeding information from a health facility {OR=2.45(1.24-4.87); (p=0.010)}. The major barriers to EBF were: pressure from partners/relatives, cultural infant feeding practices such as giving of pre- and post-lacteal feeds, heavy maternal workload, and maternal separation from infants for long periods. The study findings show that MTMSGs, a community based intervention is an effective strategy in promoting EBF and should therefore be strengthened in the promotion of EBF programmes. 11/10/2019 11/10/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://ir-library.ku.ac.ke/handle/123456789/13516
Changes to trial information