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Recruiting

NCT Number: NCT06898346

Ghana MHL Project, Tamale

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.

Recruiting

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tamale Teaching Hospital

Tamale, Northern Region, Ghana

Location status: Recruiting

Location contact

Alice Ziyaaba, MSc, RD

CONTACT

[email protected]

+233555557618

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Health Literacy

    Time frame: 10-12 weeks

    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).

  2. Dietary Diversity in Women

    Time frame: 15-17 weeks

    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)

Secondary outcomes

  1. Nutrition Knowledge

    Time frame: 15-17 weeks

    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)

  2. Infant birth weight

    Time frame: 20 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Ziyaaba, MSc, RD

CONTACT

[email protected]

Ruthfirst EA Ayande, PhD, MSc, RD

CONTACT

[email protected]

617-909-5619

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Nestlé Foundation
  • University of Ghana

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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