Improving Cognition and Gestational Duration with Targeted Nutrition (COGENT)

Washington University in St. Louis0 个研究点目标入组 1,600 人开始时间: 2023年5月25日最近更新: 2024年3月4日

适应症

试验速览

暂无简介。

•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 = 16 years of age will be allowed to consent for themselves
•1b. Women < 16 years of age 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 within planned study timeframe
•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 = 16 years of age will be allowed to consent for themselves
•1b. Women < 16 years of age 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 within planned study timeframe
•3. Patient Health Questionnaire-9 score = 9

•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

发起方