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.: PACTR202105884493022 Date of Approval: 19/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A behavioural change communication intervention to decrease the provision of water to children under six months of age in the Republic of Guinea.
Official scientific title A theory-based behavioural change communication intervention to decrease the provision of water to children under six months of age in the Republic of Guinea: a quasi-experimental trial.
Brief summary describing the background and objectives of the trial In many countries, the provision of water in the early months of a baby`s life jeopardises exclusive breastfeeding. To overcome this issue, behaviour change communication strategies should address beliefs underlying this practice. This study assessed the impact of a behaviour change intervention on the provision of water to children under six months of age in two regions of Guinea.
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 Behavioral change interventions
Anticipated trial start date 02/11/2020
Actual trial start date 01/12/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/01/2021
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 294
Recruitment status Completed
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Behavioral change communication interventions focusing on water provision. 1 30 minutes per session The intervention was designed to develop a more positive attitude towards the non-provision of water among mothers. Therefore, information on behavioural beliefs that were not favourable to the provision of water were used to design the four key messages to be delivered to the intervention group. Key messages from existing counselling material were used to design the content of the intervention. These messages were the followings: i) Breast milk contains all the water a baby needs for the first six months of life, even in a hot, dry climate; ii) Even if you do not have enough milk in your breast, the amount you give your baby will meet his or her nutritional needs for the first six months of life; iii) The more your baby sucks, the more breast milk you will produce to feed him. So, you will not need to give him water until he is six months old; iv) Giving water to a baby under six months old can make him sick. These messages and the facilitation guide were reviewed by experts of the National Nutrition Technical Group. For each key message, colour images printed on A2 paper were used to support the mothers' understanding. For example, to illustrate the composition of breast milk, a picture of a drop of water with two colours (blue for water and orange for micro and macronutrients). Also, images of fruits and vegetables were used to illustrate the evolution of a baby's stomach volume up to six months of age. The above messages were directly translated into the three local languages during each education session. Every group education session intended to last a maximum of thirty (30) minutes and be given only once, with ten (10) to fifteen (15) mothers per session. 150
Control Group Routine behavioral communication interventions Monthly 15 minutes. Routine general nutrition education delivered by health providers in health centers. 150 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Being a mother aged 20 years or older who gave birth vaginally to a unique child with a birth weight greater than 2.5 kg and was breastfeeding. Mothers of infants under six months of age who had severe medical (e.g. mental health issues), obstetric complications (e.g. c-section), babies with severe medical conditions (e.g. HIV/AIDS) or congenital malformations and aged below 20 years were excluded. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 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
Yes 15/04/2020 Comite de la recherche avec les etres humains
Ethics Committee Address
Street address City Postal code Country
18 avenue Antonine Maillet, Universite de Moncton Moncton E1A 3E9 Canada
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 09/10/2020 Comite National Ethique pour la Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
Rue de Commerce, Kaloum Conakry 224 Guinea
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Behavioral change specifically reduction of the proportion of mothers providing water to children under six months of age in addition to breast milk Before and after the intervention.
Secondary Outcome Improved exclusive breastfeeding rate. Before and after the intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ministry of Health and Public Hygiene Rue du Commerce, Kaloum Conakry BP 585 Guinea
FUNDING SOURCES
Name of source Street address City Postal code Country
Universite de Moncton 18 Antonine Maillet, Universite de Moncton Moncton Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Universite de Moncton 51 Avenue Antonine Maillet Moncton Canada University
COLLABORATORS
Name Street address City Postal code Country
Mamady Daffe Rue du Commerce, BP 585 Conakry Guinea
Noel Marie Zagre 141, Impasse Pascal NZE BIE,Z.I, UNICEF Gabon Libreville Gabon
Jeremie B. Dupuis 68 Notre Dame Sacre Coeur Moncton Canada
Sonia Blaney 18 Avenue Antonine Maillet, Universite de Moncton Moncton Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nemanan Richard Ninamou enn9139@umoncton.ca +14389922551 32 Ward Street
City Postal code Country Position/Affiliation
Moncton Canada Universite de Moncton
Role Name Email Phone Street address
Public Enquiries Mamady Daffe daffemdy@gmail.com +224622522681 Rue du Commerce, Ministere de la Sante
City Postal code Country Position/Affiliation
Conakry Guinea Ministere de la Sante et de Hygiene Publique
Role Name Email Phone Street address
Scientific Enquiries Sonia Blaney sonia.blaney@umoncton.ca +15819917782 18 Avenue Antonine Maillet
City Postal code Country Position/Affiliation
Moncton Canada Universite de Moncton
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that support the findings of this study are available from the corresponding author upon reasonable request. Informed Consent Form,Study Protocol The first paper with partial results of the research will be available within a month, the second within 3 months and the third one within 5 months. The data that support the findings of this study are available from the corresponding author upon reasonable request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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