Ghana MHL Project, Tamale

NCT06898346 | Not Yet Recruiting

• 1 other identifier: 2000038987
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

Maternal Health Literacy; Dietary Diversity; Nutrition Education; RCT; Ghana; Nutrition Knowledge

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Nutrition Knowledge

  15-17 weeks

• Infant birth weight

  20 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The treatment group will receive 6 nutrition education and counseling sessions

Behavioral: Nutrition Education

Control

NO INTERVENTION

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

Nutrition Education BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead
• University of Ghana: collaborator
• Nestlé Foundation: collaborator

Study Sites (1)

Tamale Teaching Hospital

Tamale, Northern Region, Ghana

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ruthfirst EA Ayande, PhD, MSc, RD

  Yale University

  PRINCIPAL INVESTIGATOR

• Gloria E Otoo, PhD

  University of Ghana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruthfirst EA Ayande, PhD, MSc, RD

CONTACT

617-909-5619; ruthfirst.ayande@yale.edu

Alice Ziyaaba, MSc, RD

CONTACT

aziyaaba@uds.edu.gh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)