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.: PACTR202307882241657 Date of Approval: 27/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact Evaluation of the Stawisha Maisha Cash Plus Intervention to Improve Child Nutrition
Official scientific title Impact Evaluation of the Stawisha Maisha Cash Plus Intervention to Improve Child Nutrition
Brief summary describing the background and objectives of the trial While stunting has significantly decreased nationally from 42% in 2010 to 34% in 2016 to 30% in 2022. Tanzania still suffers from high levels of child malnutrition, with roughly 3 million children under the age of five experiencing stunting. A meta-analysis of 21 papers on 17 cash transfer programmes found that while the average impact of cash transfers on height-for-age was positive, the meta-analysis estimate was small and not statistically significant. In light of this mixed evidence, a cash plus approach, whereby cash is combined with complementary programming [for example, behaviour change communication (BCC) or linkages to existing services], is often advocated. The aim of this study is to evaluate the effects of the Stawisha Maisha ‘Nourishing Life’ intervention implemented by the Tanzania Social Action Fund (TASAF) as part of the Productive Social Safety Net (PSSN) II. The intervention will target mothers/caregivers from rural TASAF PSSN cash transfer households that include children under the age of five years. The intervention is comprised of: 1) weekly radio broadcasts over 6 months, 2) provision of a solar-powered radio (one per group), and 3) peer-led radio listening groups. The impact evaluation researchers from EDI Global, Policy Research Solutions LLC (PRESTO), and Empathea will have no role in the design or implementation of the intervention Stawisha Maisha II. The overarching research question to be answered by the present research study / impact evaluation is, how and to what extent Stawisha Maisha II – a ‘plus component’ integrated in government structures within a cash transfer programme – affects nutrition outcomes of mothers and young children and their intermediate and underlying determinants. The study will take place in three regions, Geita, Rukwa, Two rounds of data collection will be implemented (baseline in 2023 and endline in 2024). Fieldwork will be implemented by EDI Global (quantitative) and Empathea (qualitative).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 11/07/2023
Actual trial start date
Anticipated date of last follow up 30/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 2252
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 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention Group 12 months The intervention group will receive the following 'plus' components in addition to the TASAF PSSN cash transfer: 1) weekly radio broadcasts over 6 months 2) provision of a solar-powered radio (one per group), and 3) peer-led radio listening groups 1126
Control Group Control Group 12 months During the 12 month evaluation period, the control group will receive only the TASAF PSSN cash transfer and not the Stawisha Maisha 'plus' components received by the intervention group. 1126 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Resides in a household participating in the Government of the Republic of Tanzaina's Productive Social Safety Net Programme (PSSN) 2. Living in rural villages with at least 9 PSSN households 3. A child under the age of 5 years resides in the household 4. Living in one of the three selected regions: Geita, Rukwa or Ruvuma 1. Not a Tanzanian PSSN beneficiary household 2. Not living in rural villages with at least 9 PSSN households 3. No children under age of 5 years in the household 4. Living in a region other than Geita, Rukwa or Ruvuma 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 100 Year(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 05/07/2023 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
2448 Barack Obama Drive Dar es Salaam 11101 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child stunting prevalence Baseline in 2023 and endline in 2024
Primary Outcome Household: Dietary diversity, Child growth monitoring, Nutrition knowledge Baseline in 2023 and endline in 2024
Primary Outcome Maternal: Dietary diversity, Meal frequency, Antenatal Care visits, Health-seeking behaviors Baseline in 2023 and endline in 2024
Primary Outcome Child: Iron-rich food consumption, Dietary diversity, Meal frequency, Exclusive breastfeeding, Morbidity (diarrhea, fever, etc.), Early childhood development Baseline in 2023 and endline in 2024
Secondary Outcome Maternal/caregiver operational knowledge about nutrition Baseline in 2023 and endline in 2024
Secondary Outcome Maternal/caregiver motivation to adopt and sustain recommended feeding practices Baseline in 2023 and endline in 2024
Secondary Outcome Maternal/caregiver self-efficacy about adopting and sustaining recommended feeding practices Baseline surveys in 2023 and follow-up surveys in 2024
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanzania EDI Global P.O. Box 393 Bukoba Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
UNICEF P.O. Box 4076 Dar es Salaam United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNICEF Tanzania P.O. Box 4076 Dar es Salaam United Republic of Tanzania Funding Agency
Secondary Sponsor Tanzania Social Action Fund P. O. BOX 2719 Dar es Salaam Tanzania Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Tanzania EDI Global P.O. Box 393 Bukoba United Republic of Tanzania
Empathea 17 Tandara Street Dar es Salaam United Republic of Tanzania
Policy Research Solutions LLC 347 Cadman Drive Buffalo 14221 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tia Palermo tiampalermo@policyresearchsolutions.com 7168295368 268F Farber Hall
City Postal code Country Position/Affiliation
Buffalo 14221 United States of America President PRESTO Policy Research Solutions LLC
Role Name Email Phone Street address
Scientific Enquiries Tia Palermo tiampalermo@policyresearchsolutions.com 7168295368 268F Farber Hall
City Postal code Country Position/Affiliation
Buffalo 14214 United States of America President PRESTO Policy Research Solutions LLC
Role Name Email Phone Street address
Public Enquiries Tia Palermo tiampalermo@policyresearchsolutions.com 7168295368 268F Farber Hall, University at Buffalo
City Postal code Country Position/Affiliation
Buffalo 14214 United States of America President PRESTO Policy Research Solutions LLC
Role Name Email Phone Street address
Principal Investigator Lusajo Kajula sajokm@gmail.com +255767339755 PO Box 75325
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Executive Director Empathea Consulting
Role Name Email Phone Street address
Principal Investigator Respichius Mitti d.mitti@edi-global.com +255754924472 MR42 HX5
City Postal code Country Position/Affiliation
Bukoba United Republic of Tanzania Regional Director
Role Name Email Phone Street address
Principal Investigator Johanna Choumert Nkolo j.choumert.nkolo@edi-global.com +255754924472 MR42 HX5
City Postal code Country Position/Affiliation
Bukoba United Republic of Tanzania Director of Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be shared nor made available. However, we will share the study protocol and questionnaires publicly online. Study Protocol Participant data will not be shared but protocol and questionnaire will be made publicly available online from May 2024-indefinite Participant data will not be shared but protocol and questionnaire will be made publicly available online at https://transfer.cpc.unc.edu/
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://transfer.cpc.unc.edu/ 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