ClinicalTrials.gg
RecruitingNCT06898346Updated May 8, 2026

Ghana MHL Project, Tamale

An interventional study of Nutrition Education in Pregnancy, sponsored by Yale University. Recruiting at 1 site in Ghana. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Yale University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

This study is designed to test a nutrition education program that focuses on local foods in northern Ghana. The goal is to help pregnant women eat a wider variety of foods, increase their intake of protein, energy, and iron-rich foods, and support healthy weight gain during pregnancy. We want to understand how this program impacts mothers' knowledge about nutrition and health, and how it affects the health of their babies. The program was created with input from pregnant women and health professionals in the community.

02

Conditions studied

  • Pregnancy

Keywords

  • Maternal Health Literacy
  • Dietary Diversity
  • Nutrition Education
  • RCT
  • Ghana
  • Nutrition Knowledge
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • Nulliparous pregnant (first-time) mothers (\<20kg/m2) between the ages of 18 and 40 attending antenatal sessions and in their second trimester, gestational ages (GA) of 16 weeks to 20 weeks, who are not carrying multiple fetuses

Exclusion criteria

Exclusion Criteria:

  • Women with pregnancies greater than 20 weeks gestation, to ensure adequate exposure to the intervention; mothers presenting with significant morbidity or who are admitted due to complications and mothers who cannot confirm an address or contact information and do not plan to deliver at a health facility as well as those who indicate that they would not deliver in the study region (those who will be out of town at time of delivery).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Intervention

    The treatment group will receive 6 nutrition education and counseling sessions

    Behavioral: Nutrition Education

  • No intervention
    Control

    The control group will not receive the program's nutrition education intervention, However, to minimize the Hawthorne effect (Sedgwick, 2012) on the intervention, the control group will be visited as well but will receive education on personal hygiene only. All participants will continue to receive any education that is part of standard care from their primary care providers

Interventions

  • BehavioralNutrition Education

    The treatment group will receive nutrition education (NE) and counseling 6 times. The 1st and 6th counselling sessions will be administered by a Registerd Dietitan in a health facility (weeks 21-22 and weeks 31-32). Four (4) bi-weekly follow-ups between these 2 sessions will be administered by Field Assistants (weeks 23, 25, 27 and 29) at the participant's home. NE will focus on dietary diversity and minimum meal frequency (Daniel et al, 2016; Gyimah et al., 2021), protein and energy intakes (Ota et al, 2015), intake of iron-rich foods (Otoo and Adam, 2016), guidelines for pregnancy with an emphasis on appropriate weight gain (Abubakar et al, 2016), and appropriate ingredients and food preparation methods required to optimize nutrition.

06

What researchers measure

Primary outcomes

  1. Health Literacy

    Health literacy (HL) in women will be assessed using the All Aspects of Health Literacy Scale (AAHLS) developed by Chinn and McCarthy (2013), and maternal health literacy (MHL) will be assessed using an abridged version of the Maternal Health Literacy Inventory In Pregnancy (MHELIP) (Taheri et al, 2020).

    Time frame: 10-12 weeks

  2. Dietary Diversity in Women

    Maternal dietary diversity will also be determined from 24-hr recalls by assessing how many food groups a woman consumed each day based on FAO definitions (FAO and FHI 360, 2016)

    Time frame: 15-17 weeks

Secondary outcomes

  1. Nutrition Knowledge

    Maternal nutrition knowledge (NK) will be assessed with a questionnaire adapted from abridged versions of 2 previously validated questionnaires (de Jersey et al., 2013; Parmenter and Wardle, 1999)

    Time frame: 15-17 weeks

  2. Infant birth weight

    Infant's weight at birth and other anthropometry (length, head circumference) is usually collected within 24 hours at the hospitals using infant weighing scales.

    Time frame: 20 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Apr 2027, 13 months after the start.

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

Registered
Mar 20, 2025
First posted
Mar 27, 2025
StartActual
Mar 31, 2026
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
May 8, 2026
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 May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06898346
Lead sponsor
Yale University
Collaborators
University of Ghana, Nestlé Foundation
Responsible party
Sponsor
First posted
Mar 27, 2025
Start date
Mar 31, 2026
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
May 8, 2026

Study contacts

Ruthfirst EA Ayande, PhD, MSc, RD
Contact
ruthfirst.ayande@yale.edu
617-909-5619
Alice Ziyaaba, MSc, RD
Contact
aziyaaba@uds.edu.gh
Ruthfirst EA Ayande, PhD, MSc, RD
principal investigator · Yale University
Gloria E Otoo, PhD
principal investigator · University of Ghana

Oversight

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

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