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.: PACTR201806003369302 Date of Approval: 04/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving developmental outcomes of infants born out of teenage pregnancies through information and psycho-social support
Official scientific title Effectiveness of an interactive text messaging and structured psychosocial support groups on developmental milestones of children from adolescent pregnancies in Kenya: a quasi-experimental study
Brief summary describing the background and objectives of the trial Two sub-counties were allocated to receive interactive text-messaging only (limited package) while two received a combination of text messaging and support groups (full package); a post-only control group was recruited at endline. Follow-up period was nine months. Key outcomes were maternal knowledge on childcare and infant development milestones assessed using the Developmental Milestones Checklist (DMC III). Knowledge and DMC scores were compared as continuous variables using means and T-tests. A comparison county was recruited at end-line (post-only control). The criteria for selection of the counties (5 counties out of 8 in Homa Bay County, Kenya) included geographical spread in the county, accessibility and the strength of the community strategy structures, which this study was based on. Objectives: Primary objective To determine the efficacy of combination of an interactive text-messaging service and community support visits for teenage mothers in improving early infant development. Secondary objectives 1. To determine whether attainment of motor milestones differs by treatment arm 2. To determine if language development milestones at 6 and 12 month differ by study arm 3.To determine if exclusive breastfeeding rates differs by study arm 4. To determine whether incidence of diarrhoea, malaria and pneumonia differs by study arm. 5. To find out if weight for length and age, at 6 and 12 months differs by study arm 6. To find determine if vaccination status at 12 months differs by study arm 7. To determine if achievements of milestones at 6 and 12 months differs by study arm.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) I BONGO
Disease(s) or condition(s) being studied Infant Development,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/04/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 31/03/2020
Actual Last follow-up date 30/06/2020
Anticipated target sample size (number of participants) 1680
Actual target sample size (number of participants) 1060
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
SB-POC-1810-19773 Grand Challenges Canada
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 This will be a cluster randomized trial, with community health units (CHUs) as the clusters. A list of all the CHUs in target sub-counties of Homa Bay County, Kenya will form the sampling frame, and randomisation using a radomisation table created by a computer software program. CHUs will be assigned to four groups, A,B,C and D. Each then will receive one of the three intervention packages, fourth will be control. All teenage mothers in the respective CHUs will receive the intervention for that CHU. Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Text messages combined with voice call weekly 3 months One voice call weekly, three text messages every week 420
Experimental Group Text messages via mobile phone Three messages every week 3 months Three messages will be sent to participants in this arm every week 420
Experimental Group Text messages, voice call and community visit 3 messages weekly, one call weekly, one visit monthly 3 months Messages will be sent to participants' phones, one voice call will be made every week and they will receive visits by a community health volunteer every month 420
Control Group Usual care None 3 months These mothers will receive routine post-natal followup as per the Kenya Country guidelines 420 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Teenager mother (age less than 20 years) with a child below 3 months of age 2. Current resident of Rangwe, Ndhiwa or Karachuonyo Subcounties, Homa Bay County 3. Willing to sign consent form for the study 1. Plan to move out of study area within the next 12 months 2. Lack of access to a mobile phone 13 Year(s) 19 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
No 15/06/2018 Kenyatta National Hospital/University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 19676, Kenyatta National Hospital Grounds Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Head circumference as a marker for overall brain development 1.After six months of followup
Primary Outcome Head circumference as a marker for overall brain development After 12 months of followup
Secondary Outcome Diarrhoea incidence, wasting, stunting, motor and language milestones After six months of followup
Secondary Outcome Diarrhoea incidence, wasting, stunting, motor and language milestones After 12 months of followup
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ndhiwa Subcounty Homa Bay County Homa Bay Kenya
Rangwe Subcounty Homa Bay County Homa Bay Kenya
Karachuonyo Subcounty Homa Bay County Homa Bay Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada 661 University Avenue, Suite 1720 Toronto, ON M5G 1M1 Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Field Epidemiology Society of Kenya Kenyatta National Hospital Grounds, P.O. Box 22313 NAIROBI 00100 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Kenya Field Epidemiology and Laboratory Training Programme Kenyatta National Hospital Grounds, P. O Box 22313 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Valerian Mwenda valmwenda@gmail.com +254723992573 P.O. Box 22313
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya Kenya Field Epidemiology and Laboratory Training Programme
Role Name Email Phone Street address
Public Enquiries Valerian Mwenda valmwenda@gmail.com +254723992573 P.O. Box 22313
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya Kenya Field Epidemiology and Laboratory Training Programme
Role Name Email Phone Street address
Scientific Enquiries Mark Obonyo mobonyo@feltp.or.ke +254722591818 P.O. Box 22313
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya Kenya Field Epidemiology and Laboratory Training Programme
REPORTING
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Changes to trial information