Background
Methods
Study setting
Study design and randomization
Clusters and study populations
Recruitment
Sample size considerations
Intervention
Step | Description |
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Step 1 | Have a written MIYCN policy summary statement that is routinely communicated to all health providers, community health volunteers and community |
Step 2 | Train all health care providers and community health volunteers in the knowledge and skills necessary to implement the MIYCN policy |
Step 3 | Promote optimal maternal nutrition among women and their families |
Step 4 | Inform all mothers and their families about the benefits of breastfeeding and risks of artificial feeding |
Step 5 | Support mothers to initiate breastfeeding within the first hour of birth, establish and maintain exclusive breastfeeding for first 6 months |
Step 6 | Encourage sustained breastfeeding beyond 6 months to 2 years or more alongside timely introduction of appropriate, adequate and safe complementary foods |
Step 7 | Provide a welcoming and conducive environment for breastfeeding families |
Step 8 | Promote collaboration between health care staff, maternal, infant and young child nutrition support groups and the local community |
Intervention group | Control group |
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a) Distribution of MIYCN educational materials (usual care) | a) Distribution of MIYCN educational materials (usual care) |
b) Supportive supervision (scheduled regular visits to assess implementation of BFCI package) | b) Supportive supervision (usual planned visits by DHMT) |
c) CHW motivation package (provision of a monthly stipend (seed money for an income generating activity as a group) and training for income-generation activities as incentive) | c) CHW motivation package (Seed money for an income generating activity as a group same as in the intervention group) |
d) Orientation, and continuous on job training and mentoring of the HWs and CHWs/CHEWs on BFCI package implementation | |
e) Formation and support of mother support groups in the community |
• Maternal nutrition: | |
Food portions during pregnancy and lactation | |
Appropriate foods (nutritious, affordable, and locally available) during pregnancy and lactation | |
Frequency of feeding during pregnancy and lactation | |
• Breastfeeding: | |
Breast positioning and attachment | |
Immediate initiation of breastfeeding after birth | |
Exclusive breastfeeding for 6 months | |
Frequency and duration of breastfeeding | |
Expressing breast milk, storage and cup feeding | |
Dealing with breast conditions | |
Breastfeeding for HIV-positive women | |
• Complementary feeding: | |
Timely initiation of complementary foods | |
Appropriate complementary foods (nutritious, affordable, and locally available) | |
Feeding frequency and quantity | |
Appropriate feeding practices including hygiene and responsive feeding behaviors | |
Safe preparation and storage of foods |
Assessment
Primary outcome
Secondary outcomes
Qualitative
Quantitative
Data collection and analysis
Formative study | ||
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Study objective | Data/variables | Method |
1. To establish local contexts and norms, which influence Maternal, Infant and Young Child Nutrition (MIYCN) practices in order to tailor the intervention package to the local communities | Attitudes and practices regarding breastfeeding and other MIYCN practices; cultural and social factors and norms that influence MIYCN | Focus group discussions (FGDs) with community members (women and men and community health workers); key informant interviews (KIIs) with key informants including community administrators and other leaders (e.g. religious group leaders), traditional birth attendants (TBAs); KIIs with facility health workers, CHWs and Sub-County Health Management (ScHMT) team |
2. To identify enabling factors and barriers that may influence the implementation of BFCI and potential ways of addressing them | Key players and structures in the community that would facilitate implementation of BFCI (key influential people in the community, community resource persons that would be involved in the implementation of the project, other useful community resources); factors (e.g. socioeconomic, maternal age, social/family support) that influence uptake of interventions in the community; any potential hindrances to the success of the intervention (e.g. myths, beliefs) | Key informant interviews (KIIs) with key informants including community administrators and other leaders (e.g. religious group leaders), traditional birth attendants (TBAs); KIIs with facility health workers, CHWs and (ScHMT) team, FGDs with mothers and fathers |
Cluster randomized trial | ||
Study objective | Variable/Data | Methods |
Primary objective | ||
1. To determine the effectiveness of the BFCI on the rates of exclusive breastfeeding for the first 6 months | Duration of exclusive breastfeeding as a derived variable: age of child, current status of breastfeeding (exclusive, mixed feeding, not breastfeeding) with probes on the age at introduction of other foods or liquids (if appropriate), and a 24-hour recall feeding question | Quantitative: questionnaires to mothers and 24-hour recall at 2, 4 and 6 months; |
Secondary objectives | ||
2. To determine the effectiveness of the BFCI on breastfeeding and other MIYCN knowledge, attitudes and practices | Breastfeeding and other MIYCN knowledge, attitudes and practices including breast positioning attachment, and frequency of feeding | Quantitative: questionnaires to mothers (at baseline and end-line) |
3. To determine the effectiveness of the BFCI on rate of initiation of breastfeeding within the first hour of birth | Timing of initiation of breastfeeding with specific prompts on whether infant was put to breast immediately, within 1 hour or later, reasons for the delay in initiation of breastfeeding | Quantitative data gathered from interviews with mothers within 2 months of the birth of the child |
4. To determine the effectiveness of the BFCI on nutritional and health status of children aged 6 months and below. | Anthropometric measurements including MUAC, weight and length morbidity from diarrhea using 14- day recall | Quantitative: using questionnaires, MUAC tapes, electronic weighing scale and measuring board at 2, 4 and 6 months |
5. To determine satisfaction with the intervention, and the enabling factors/barriers associated with the implementation of the BCFI | Facilitating factors and barriers associated with intervention; Client satisfaction, experiences with intervention and with the processes of delivering it | Quantitative data: Likert scale (satisfaction) at end-line Qualitative: interviews with mothers, community opinion leaders, HWs and CHWs (experiences, facilitating factors and barriers) at midline and end-line |
Qualitative data collection before, during and after the intervention
Qualitative data analysis
Quantitative data collection
Statistical analysis
Formative study | ||||
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Study objective | Primary outcome variables | Independent variable | Control variables | Type of analysis |
1. To establish local contexts and norms, which contribute to maternal infant and young child nutrition (MIYCN) practices so as to customize the intervention package | Factors that influence breastfeeding and other MIYCN practices | Not applicable | Not applicable | Thematic |
2. To identify facilitating factors and barriers that may influence the implementation of BFCI | Facilitating factors and barriers to the implementation of BFCI | Not applicable | Not applicable | Thematic |
Cluster randomized trial | ||||
Study objective | Outcome variables | Independent variable | Control variables | Type of analysis |
1. To determine the effectiveness of the BFCI on the rates of exclusive breastfeeding for the first 6 months | Exclusive breastfeeding (EBF) at 6 months, 4 months and 2 months | Intervention status | SES, food security, water and sanitation, maternal characteristics, antenatal care | Multinomial logistic regression |
2. To determine the effectiveness of BFCI strategy on MIYCN knowledge and attitudes | a. Knowledge levels on MIYCN | Intervention status | SES, food security, water and sanitation, maternal characteristics, antenatal care | Logistic regression |
b. Attitudes on MIYCN | ||||
3. To determine the effectiveness of the BFCI on rate of initiation of breastfeeding within the first hour of birth and its implications on successful EBF for the first 6 months | Initiation of breastfeeding within 1 hour | Intervention status | SES, food security, water and sanitation, maternal characteristics, antenatal care | Logistic regression |
4. To assess the change in nutritional and health status among infants and young children from the implementation of BFCI | a. Stunting | Intervention status | SES, food security, water and sanitation maternal characteristics, antenatal care, vaccination status | Logistic regression for stunting, underweight and wasting |
b. Underweight | ANCOVA for z-scores and multilevel modeling for diarrhea morbidity | |||
c. Wasting | ||||
d. z-scores | ||||
e. Diarrheal and other morbidity | ||||
5. To determine the factors and barriers associated with the implementation of BCFI and how to address them | a. Satisfaction with intervention | Not applicable | Not applicable | Descriptive (Outcome 1) |
b. Experiences with intervention | Qualitative: Thematic analysis (Outcomes 2 and 3) | |||
c. Limiting and enabling factors |