PREPARE: Remote Nutrition Education, Ghana

PREPARE Project: Examining Impacts of the COVID-19 Pandemic on Maternal Health and Infant and Young Child Feeding Practices

In the wake of the pandemic, it is important to explore remote nutrition education programs during the pre- and postnatal period. This is the second phase of a bigger project, where a 6-week intensive remotely delivered nutrition and health education program called the PREPARE program will be piloted. Prepare stands for "Perinatal Remote Education for Pandemic Resilience", and it is a nutrition and health education program meant for pregnant and lactating women aimed at improving maternal and infant dietary diversity, maternal health literacy and increasing COVID-19 awareness. One hundred women will be selected from a pool of 233 women who completed a baseline survey last year. Fifty of them will receive the intervention and the other 50 will receive a delayed intervention.

Study Overview

• Status: Enrolling by invitation
• Conditions: Health Literacy; Dietary Diversity; Infant Feeding Practices
• Intervention / Treatment: Behavioral: PREPARE Nutrition Education Module

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Accra, Ghana
    • University of Ghana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women currently enrolled on the preliminary phase of the PREPARE project who participated in our baseline survey are eligible. To have been part of the preliminary survey, women had to have had children between 6 and 15 months old during recruitment last year.
• Due to our primary outcome of infant dietary diversity, women from our preliminary survey whose children are currently between 6 months and 2 years will be included in the PREPARE pilot study.

Exclusion Criteria:

• In our preliminary survey, participants were excluded if they were non-Ghanaian or currently pregnant.
• Besides women who had children less than 6 months at time of recruitment, there will be no other exclusion criteria for the PREPARE pilot.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prepare project education; This group will receive an intensive 6-week remote nutrition education intervention	Behavioral: PREPARE Nutrition Education Module; The Perinatal Remote Education for Pandemic Resilience (PREARE) program is a 6-week intensive program aimed at increasing maternal and infant dietary diversity as well as maternal health literacy. Modules that will be completed in the program include education on early initiation of breastfeeding, food groups and the benefits of a balanced diet, appropriate meal frequency for mother and infant, and appropriate sources of health information. Information on personal hygiene and COVID-19 hygiene protocols as well as danger signs during pregnancy are included in the module to improve maternal knowledge on safety protocols and pregnancy complications.
Other: Delayed intervention; This is the "control" group. They will not receive the intervention when the project is active, during which time they will serve as a control. Due to ethical considerations however, they will receive a delayed intervention after the initial intervention period is done.	Behavioral: PREPARE Nutrition Education Module; The Perinatal Remote Education for Pandemic Resilience (PREARE) program is a 6-week intensive program aimed at increasing maternal and infant dietary diversity as well as maternal health literacy. Modules that will be completed in the program include education on early initiation of breastfeeding, food groups and the benefits of a balanced diet, appropriate meal frequency for mother and infant, and appropriate sources of health information. Information on personal hygiene and COVID-19 hygiene protocols as well as danger signs during pregnancy are included in the module to improve maternal knowledge on safety protocols and pregnancy complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% infants meeting the Minimum Dietary Diversity (MDD)	Dietary diversity refers to the number of food items consumed from WHO classified food groups over a reference period (FAO, 2016). To meet the minimum dietary diversity, infants should have consumed 4 out of 7 food groups based on a 24-hr dietary recall and the WHO food group classification: 1. grains, roots and tubers, 2. legumes and nuts, 3. dairy products (milk, yogurt, cheese), 4. flesh foods (meat, fish, poultry and liver/organ meats), 5. Eggs, 6. vitamin-A rich fruits and vegetables, 7. other fruits and vegetables	6 weeks
% of Mothers meeting the Minimum Dietary Diversity for women (MDD-W)	Number of food items consumed from WHO classified food groups over a reference period (FAO, 2016). To meet the minimum dietary diversity, mothers should have consumed 5 out of 10 food groups based on a 24-hr dietary recall and the WHO food group classification: 1. Grains, white roots and tubers, and plantains, 2. Pulses (beans, peas and lentils) 3. Nuts and seeds 4. Dairy 5. Meat, poultry and fish 6. Eggs 7. Dark green leafy vegetables 8. Other vitamin A-rich fruits and vegetables 9. Other vegetables 10. Other fruits	6 weeks
% of mothers scoring >66% on the maternal health literacy inventory in pregnancy (MHELIP) scale.	Maternal health literacy (MHL) is the cognitive and social skills which determine the motivation and ability of individuals (mothers) to gain access to, understand and use information in ways which maintain and promote health for they and their children (Renkert and Nutbeam, 2001). This will be measured on the maternal health literacy inventory in pregnancy (MHELIP) scale (Taheri et al., 2020).	6 weeks

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: University of Ghana
• Investigators: Principal Investigator: Ruthfirst EA Ayande, MSc, University of Massachusetts, Amherst; Study Chair: Elena T Carbone, DrPH, University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Anticipated): January 9, 2023
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2578

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No