PREPARE: Remote Nutrition Education, Ghana

October 29, 2024 updated by: Ruthfirst Ayande, University of Massachusetts, Amherst

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Accra, Ghana
        • University of Ghana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
% infants meeting the Minimum Dietary Diversity (MDD)
Time Frame: 6 weeks
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)
Time Frame: 6 weeks
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.
Time Frame: 6 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Amherst

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Ghana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ruthfirst EA Ayande, MSc, University of Massachusetts, Amherst
  • Study Chair: Elena T Carbone, DrPH, University of Massachusetts, Amherst

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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