Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Research Plan for a Randomised, Single-blind, Parallel Group Controlled Trial in Rural Malawi, Testing the Health Effects of Supplementing Maternal Diet During Pregnancy and Lactation and Infant Diet From 6 to 18 Months of Age With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Brief Summary: The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only.

To detect the long-term effect of the LNS supplementation, we now propose to conduct a follow-up study when the children are 9 years old, to see if the intervention had effect on children's growth, cardiometabolic and respiratory status and neurocognitive development.


Options:
A: Inclusion Criteria:

* Signed informed consent from at least one guardian
* Age 5.50 months to 6.49 months
* Availability during the period of the study.
* Permanent resident of Mangochi District Hospital or Namwera Health Centre catchment area

Exclusion Criteria:

* Weight for length Z score (WLZ) \< -2.0
* Presence of oedema
* Severe anaemia (Hb\<50 g / l)
* Severe illness warranting hospital referral
* History of allergy towards peanut
* History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
* Concurrent participation in any other clinical trial
B: Inclusion Criteria:

* Ultrasound confirmed pregnancy of no more than 20 completed gestation weeks
* Permanent resident of Mangochi District Hospital, Malindi Hospital or Lungwena Health Centre catchment areas
* Availability during the period of the study
* Signed informed consent

Exclusion Criteria:

* Less than 15 years of age
* Need for frequent medical attention due to a chronic health condition
* Diagnosed asthma treated with regular medication
* Severe illness warranting hospital referral
* History of allergy towards peanuts
* History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
* Pregnancy complications evident at enrolment visit (moderate to severe oedema, blood Hb concentration \< 5 g / dl, systolic blood pressure (BP) \> 160 mmHg or diastolic BP \> 100 mmHg)
* Earlier participation in the iLiNS-DYAD-M trial
* Concurrent participation in any other clinical trial
C: Study participants will be women who are rural residents of Chirumanzu or Shurugwi districts in Zimbabwe and who become pregnant during the enrollment period of the trial and are identified and consent to participation during pregnancy, and their live born infants. A total of 5280 women will be enrolled.

Inclusion Criteria:

Pregnant women residing in the study districts, whose pregnancy is confirmed by a urine pregnancy test.

Exclusion Criteria:

* Women residing in the study districts who become pregnant during the enrollment period but do not consent to join the trial
* Women who reside in urban areas of these two districts
* Infants with major non-fatal abnormalities will not be excluded from study procedures, but will be excluded from the final analytic sample if the abnormality is likely to directly affect gut health/function or stature (e.g. neural tube defects, cerebral palsy, Down syndrome)
D: Study Population Description:

The subject population will be young children and their mothers/guardians living in several contiguous districts of Western Province, in the rural areas outside the towns of Bungoma and Kakamega. Communities must meet the following criteria:

* Located in a rural area (defined as villages with \<25% residents living in rental houses, \<2 gas/petrol stations and \<10 shops)
* Not enrolled in ongoing WASH or nutrition programs
* No chlorine dispensers at water sources installed by programs separate from the present study
* Majority (\>80%) of households do not have access to piped water into the home
* At least six eligible pregnant women in the cluster at baseline.

From enrolled communities, household compounds will be enrolled if they meet the following criteria.

Inclusion Criteria:

1. One or more women who self-identify as pregnant at the time of the baseline survey
2. The woman plans to stay in the community for the next 12 months.

Exclusion Criteria:

(1) The study excludes households who do not own their home to help mitigate attrition during follow-up.

Answer: B