Improving nutrition and mental health for pregnant women in Sierra Leone
Improving Cognition and Gestational Duration With Targeted Nutrition
This study is testing a special nutritional supplement and therapy program to see if it can help undernourished pregnant women in Sierra Leone have healthier pregnancies and improve their mental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 10 sites (Bandajuma, Southern and 9 other locations) |
| Trial ID | NCT05949190 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of a novel maternal ready-to-use supplementary food (M-RUSF+) enriched with omega-3 fatty acids and choline, alongside a cognitive behavioral therapy (CBT) program, on undernourished pregnant women in Sierra Leone. The study will compare the outcomes of M-RUSF+ with a standard supplementary food lacking these nutrients to assess improvements in gestational duration and infant cognitive development. Additionally, the trial will investigate whether the CBT program can alleviate ante- and postpartum depression among participants. The research is designed to address significant health challenges faced by pregnant women in Sub-Saharan Africa.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 13 years and older who are undernourished, as indicated by a mid-upper arm circumference of 23 cm or less or a body mass index below 18.5.
Not a fit: Patients who are well-nourished or do not meet the specified age and health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved maternal and infant health outcomes, including longer gestation periods and enhanced cognitive development in infants.
How similar studies have performed: Previous studies have shown promising results in improving maternal and infant health through nutritional interventions in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in the M-RUSF+ vs. M-RUSF element of the study, an individual must meet all of the following criteria: 1. Provision of signed (or thumb-printed) and dated informed consent form 1a. Women who are ≥ 18 years of age or married will be allowed to consent for themselves 1b. Women who are \< 18 years of age and unmarried must provide assent and a parent or guardian must provide consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic 3. ≥ 13 years of age 4. Pregnant 5. Mid-upper arm circumference ≤ 23 cm or body-mass index \< 18.5 In order to be eligible to participate in the CBT vs. no CBT element of the study (factorial design with the above), an individual must be enrolled in the M-RUSF+ vs. M-RUSF study and meet the following criteria: 1. Provision of signed (or thumb-printed) and dated informed consent form 1a. Women who are ≥ 18 years of age or married will be allowed to consent for themselves 1b. Women who are \< 18 years of age and unmarried must assent and a parent or guardian consent must provide consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic 3. Patient Health Questionnaire-9 score ≥ 9 Exclusion Criteria: 1. Participation in a concomitant supplementary feeding program 2. Known allergy to components of intervention or control study food or medications 3. Known gestational diabetes 4. Hypertension 5. Severe anemia, or other condition requiring immediate hospitalization
Where this trial is running
Bandajuma, Southern and 9 other locations
- Bandajuma — Bandajuma, Southern, Sierra Leone (Recruiting)
- Bendu Malen — Bendu, Southern, Sierra Leone (Recruiting)
- Blama Massaquoi — Blama Massaquoi, Southern, Sierra Leone (Recruiting)
- Futa Peje — Futa Peje, Southern, Sierra Leone (Recruiting)
- Gbondapi — Gbondapi, Southern, Sierra Leone (Recruiting)
- Nyandehun Malen — Nyandehun, Southern, Sierra Leone (Recruiting)
- Potoru — Potoru, Southern, Sierra Leone (Recruiting)
- Pujehun Static — Pujehun, Southern, Sierra Leone (Recruiting)
- Sahn Malen — Sahn, Southern, Sierra Leone (Recruiting)
- Zimmi — Zimmi, Southern, Sierra Leone (Recruiting)
Study contacts
- Principal investigator: Mark J Manary, MD — Washington University School of Medicine
- Study coordinator: Mark J Manary, MD
- Email: manarymj@wustl.edu
- Phone: +1 314-454-2341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.