Improving Cognition and Gestational Duration With Targeted Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,660
- 试验地点
- 10
- 主要终点
- Malawi Developmental Assessment Tool (MDAT) global z-score
研究概览
简要总结
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?
详细描述
Undernutrition in pregnancy is common, affecting nearly 10% of women worldwide and 25% of women in Sub-Saharan Africa, and increases risks for both mothers and their offspring, including bleeding, preterm birth, neonatal mortality, and impaired infant cognitive development. Available treatments have limited impact on these outcomes, which affect millions annually. A recent trial in Sierra Leone showed that pairing high-quality supplementary nutrition with anti-infective measures led to greater maternal weight gain, longer and heavier newborns, and reduced neonatal mortality. In addition, ante- and postpartum depression are underrecognized and undertreated in rural Sub-Saharan Africa.
The goal of this clinical trial is to test (1) a novel maternal ready-to-use supplementary food (M-RUSF+) and (2) a novel cognitive behavioral therapy (CBT) program developed for illiterate users, in undernourished pregnant women in Sierra Leone. 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?
Participants will present to government-run antenatal clinics for screening. If they quality for enrollment and consent to participate, they will undergo:
ANTENATALLY
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
In the food comparison, while the 2 study foods taste similar, full masking cannot be guaranteed. In the CBT comparison, participants and therapists will not be masked. In all cases, outcomes assessors will be masked.
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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:
- •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
- •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
排除标准
- •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
研究组 & 干预措施
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) for women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Among participants randomized to receive M-RUSF+ vs. M-RUSF, those who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) (Dietary Supplement)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) for women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Among participants randomized to receive M-RUSF+ vs. M-RUSF, those who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Azithromycin (Drug)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) for women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Among participants randomized to receive M-RUSF+ vs. M-RUSF, those who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Albendazole (Drug)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) for women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Among participants randomized to receive M-RUSF+ vs. M-RUSF, those who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Sulfadoxine pyrimethamine (Drug)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) for women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Among participants randomized to receive M-RUSF+ vs. M-RUSF, those who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Cognitive behavioral therapy (Behavioral)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) for women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Among participants randomized to receive M-RUSF+ vs. M-RUSF, those who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Insecticide-treated mosquito net (Other)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/World Health Organization/United Nations multiple micronutrient supplement for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) (Dietary Supplement)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/World Health Organization/United Nations multiple micronutrient supplement for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: Azithromycin (Drug)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/World Health Organization/United Nations multiple micronutrient supplement for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: Albendazole (Drug)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/World Health Organization/United Nations multiple micronutrient supplement for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: Sulfadoxine pyrimethamine (Drug)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBT
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/World Health Organization/United Nations multiple micronutrient supplement for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: Insecticide-treated mosquito net (Other)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: M-RUSF (Maternal Ready-to-Use Supplementary Food) (Dietary Supplement)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Azithromycin (Drug)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Albendazole (Drug)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Sulfadoxine pyrimethamine (Drug)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Cognitive behavioral therapy (Behavioral)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
干预措施: Insecticide-treated mosquito net (Other)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: M-RUSF (Maternal Ready-to-Use Supplementary Food) (Dietary Supplement)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: Azithromycin (Drug)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: Albendazole (Drug)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: Sulfadoxine pyrimethamine (Drug)
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBT
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food.
Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
干预措施: Insecticide-treated mosquito net (Other)
结局指标
主要结局
Malawi Developmental Assessment Tool (MDAT) global z-score
时间窗: 9 months post-birth
Infant global age-adjusted z-score on MDAT
Adapted Patient Health Questionnaire-9 (PHQ-9) score
时间窗: 8 weeks after diagnosis with ante- or post-partum depression
Among participants who develop ante- or post-partum depression, adapted Patient Health Questionnaire-9 score, (range 0-27, higher scores are worse)
Gestational duration
时间窗: Enrollment to birth (range 2 to 26 weeks)
Enrollment ultrasound estimated gestational age plus time between enrollment and delivery. For the primary outcome, this will only be assessed among participants enrolled \<= 30 weeks gestational age and with singleton live births
次要结局
- Infant mortality(Birth to end of follow-up (9 months))
- Low birth weight(Birth)
- Neonatal mortality(Birth to 28 days of age)
- Depressive symptoms(Through study completion, an average of 1.25 years)
- Maternal and infant DHA status(From Enrollment to delivery, an average of 15 weeks)
- Birth weight(Birth)
- Early preterm birth(Enrollment to 34 weeks' gestation)
- Birth length(Birth)
- Placental weight(Birth)
- Malawi Developmental Assessment Test sub-domain z-scores(9 months after birth)
- Preterm birth(Enrollment to 37 weeks' gestation)
- Post-term delivery(From Enrollment to delivery, an average of 15 weeks)
- Maternal weight gain(From Enrollment to delivery, an average of 15 weeks)
- Infant length-for-age z-score at 6 weeks, 3 months, 6 months, 9 months(Birth to 9 months)
- Maternal and infant choline status(From Enrollment to delivery, an average of 15 weeks)
- Depression incidence(8 weeks from time of depression diagnosis)
- Birth chest circumference(Birth)
- Birth head circumference(Birth)
- Infant weight at 6 weeks, 3 months, 6 months, 9 months(Birth to 9 months)
- Infant length at 6 weeks, 3 months, 6 months, 9 months(Birth to 9 months)
- Birth thigh circumference(Birth)
- Gestational duration(From Enrollment to birth, an average of 15 weeks)
- Small for gestational age (SGA)(Birth)