ClinicalTrials.gg
CompletedNCT05677087Updated Nov 1, 2024

PREPARE: Remote Nutrition Education, Ghana

An interventional study of PREPARE Nutrition Education Module in Health Literacy, Dietary Diversity and Infant Feeding Practices, sponsored by University of Massachusetts, Amherst. Completed at 1 site in Ghana. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-01.

Sponsored by University of Massachusetts, Amherst · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years to 49 Years
Sex
Female
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Study summary

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.

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Conditions studied

  • Health Literacy
  • Dietary Diversity
  • Infant Feeding Practices

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03

In context

Literacy

201 studies on the registry are indexed under Literacy; 69 are open to participants now.

This study's enrollment of 65 is below the median of 124 across 170 interventional studies indexed under Literacy.

Browse Literacy studies →

Lead sponsor

University of Massachusetts, Amherst is the lead sponsor of 48 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Prepare project education

    This group will receive an intensive 6-week remote nutrition education intervention

    Behavioral: PREPARE Nutrition Education Module

Interventions

  • BehavioralPREPARE 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.

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What researchers measure

Primary outcomes

  1. % 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

    Time frame: 6 weeks

  2. % 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

    Time frame: 6 weeks

  3. % 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).

    Time frame: 6 weeks

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Study locations

1 site
  • University of Ghana
    Accra, Ghana
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Aug 2023, 7 months.

Of 115 non-industry interventional studies with no phase under Literacy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 20. This study's 7 months is below that.

Counting every sponsor, half of 117 studies reached it within 11 months; a quarter within 4 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2022
First posted
Jan 10, 2023
StartActual
Jan 13, 2023
Primary completionActual
Aug 31, 2023
CompletionActual
Aug 31, 2023
Last update
Nov 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05677087
Lead sponsor
University of Massachusetts, Amherst
Collaborators
University of Ghana
Responsible party
Ruthfirst Ayande (Principal Investigator, University of Massachusetts, Amherst) — Principal investigator
First posted
Jan 10, 2023
Start date
Jan 13, 2023
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Nov 1, 2024

Study contacts

Ruthfirst EA Ayande, MSc
principal investigator · University of Massachusetts, Amherst
Elena T Carbone, DrPH
study chair · University of Massachusetts, Amherst

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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