Improving Cognition and Gestational Duration With Targeted Nutrition (NCT05949190) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Improving Cognition and Gestational Duration With Targeted Nutrition
Sierra Leone1,660 participantsStarted 2023-08-18
Plain-language summary
The goal of this clinical trial is to test (1) a novel maternal ready-to-use supplementary food and (2) a novel cognitive behavioral therapy intervention in undernourished Sierra Leonean women. The main questions it aims to answer are:
* Will the addition of omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), as well as choline, to a maternal ready-to-use supplementary food (M-RUSF+) prolong gestation when compared with a similar supplementary food except that it lacks DHA, EPA, and choline (M-RUSF)?
* Will M-RUSF+ improve infant cognitive development at 9 months of age when compared with M-RUSF?
* Will the novel CBT program improve ante- and post-partum depression?
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
. ≥ 13 years of age
. Pregnant
. Mid-upper arm circumference ≤ 23 cm or body-mass index \< 18.5
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gestational duration
Timeframe: Enrollment to birth (range 2 to 26 weeks)
2
Malawi Developmental Assessment Tool (MDAT) global z-score
Timeframe: 9 months post-birth
3
Adapted Patient Health Questionnaire-9 (PHQ-9) score
Timeframe: 8 weeks after diagnosis with ante- or post-partum depression
. 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
. Patient Health Questionnaire-9 score ≥ 9
Exclusion criteria
. Participation in a concomitant supplementary feeding program
. Known allergy to components of intervention or control study food or medications
. Known gestational diabetes
. Hypertension
. Severe anemia, or other condition requiring immediate hospitalization