Improving Cognition and Gestational Duration With Targeted Nutrition

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jul 14, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on improving the health of pregnant women in Sierra Leone who are not getting enough nutrition, as well as the health of their babies. The study is testing a special type of food designed for mothers that contains important nutrients like omega-3 fatty acids and choline, to see if it helps mothers carry their babies longer and supports better brain development in their infants at 9 months old. Additionally, the trial will evaluate a new therapy program aimed at helping mothers manage feelings of sadness or anxiety before and after giving birth.

To participate, women need to be at least 13 years old, pregnant, and experiencing malnutrition, which can be measured by their body size. They should also be willing to follow the study's guidelines and stay in the area for the duration of the trial. Participants will receive either the special food or a similar type without the added nutrients, along with the opportunity to join the therapy program. This study aims to make a positive difference in the health of mothers and their children during and after pregnancy.

Gender

ALL

Eligibility 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