Ghana MHL Project, Tamale

Maternal Health, Literacy and Pregnancy Outcomes: The Role of Specialized Nutrition Education

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Nutrition Education

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruthfirst EA Ayande, PhD, MSc, RD; Phone Number: 617-909-5619; Email: ruthfirst.ayande@yale.edu
• Study Contact Backup: Name: Alice Ziyaaba, MSc, RD; Email: aziyaaba@uds.edu.gh

Study Locations

• Ghana
  • Northern Region
    • Tamale, Northern Region, Ghana
      • Recruiting
      • Tamale Teaching Hospital
      • Contact: Alice Ziyaaba, MSc, RD; Phone Number: +233555557618; Email: aziyaaba@uds.edu.gh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Nulliparous pregnant (first-time) mothers (BMI<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:

• 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The treatment group will receive 6 nutrition education and counseling sessions	Behavioral: Nutrition 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	10-12 weeks
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)	15-17 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	15-17 weeks
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.	20 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: University of Ghana; Nestlé Foundation
• Investigators: Principal Investigator: Ruthfirst EA Ayande, PhD, MSc, RD, Yale University; Principal Investigator: Gloria E Otoo, PhD, University of Ghana

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: RCT; Ghana; Nutrition Education; Dietary Diversity; Maternal Health Literacy; Nutrition Knowledge
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: 2000038987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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