Ghana MHL Project, Tamale
ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Nutrition Education
BehavioralThe 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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 weeks2
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 weeksSecondary 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 weeks2
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 weeksSponsors and contacts
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Source ClinicalTrials.gov