Please select the arm or intervention descriptions that belong 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: Arm Label: ST-DI (Delayed intervention); Type: OTHER; Interventions: Dietary Supplement: Maize-soy flour | Arm Label: LNS-10gM; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lipid-based nutrient supplement, 10gM | Arm Label: LNS-20gM; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lipid-based nutrient supplement, 20gM | Arm Label: LNS-20gNoM; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM | Arm Label: LNS-40gM; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lipid-based nutrient supplement, 40gM | Arm Label: LNS-40gNoM; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM | Intervention Type: DIETARY_SUPPLEMENT; Name: Lipid-based nutrient supplement, 10gM; Assigned to Arm(s): LNS-10gM | Intervention Type: DIETARY_SUPPLEMENT; Name: Lipid-based nutrient supplement, 20gM; Assigned to Arm(s): LNS-20gM | Intervention Type: DIETARY_SUPPLEMENT; Name: Lipid-based Nutrient Supplement, 20gNoM; Assigned to Arm(s): LNS-20gNoM | Intervention Type: DIETARY_SUPPLEMENT; Name: Lipid-based nutrient supplement, 40gM; Assigned to Arm(s): LNS-40gM | Intervention Type: DIETARY_SUPPLEMENT; Name: Lipid-based Nutrient Supplement, 40gNoM; Assigned to Arm(s): LNS-40gNoM | Intervention Type: DIETARY_SUPPLEMENT; Name: Maize-soy flour; Assigned to Arm(s): ST-DI (Delayed intervention)
B: Arm Label: IFA group; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: IFA | Arm Label: MMN group; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: MMN | Arm Label: LNS group; Type: EXPERIMENTAL; Interventions: Dietary Supplement: LNS | Intervention Type: DIETARY_SUPPLEMENT; Name: IFA; Assigned to Arm(s): IFA group | Intervention Type: DIETARY_SUPPLEMENT; Name: MMN; Assigned to Arm(s): MMN group | Intervention Type: DIETARY_SUPPLEMENT; Name: LNS; Assigned to Arm(s): LNS group
C: Arm Label: Standard of Care; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Standard care | Arm Label: WASH; Type: ACTIVE_COMPARATOR; Interventions: Other: WASH | Arm Label: Nutrition; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Infant and young child feeding | Arm Label: WASH and Nutrition; Type: ACTIVE_COMPARATOR; Interventions: Other: WASH and Nutrition | Intervention Type: BEHAVIORAL; Name: Standard care; Assigned to Arm(s): Standard of Care | Intervention Type: OTHER; Name: WASH; Assigned to Arm(s): WASH | Intervention Type: DIETARY_SUPPLEMENT; Name: Infant and young child feeding; Assigned to Arm(s): Nutrition | Intervention Type: OTHER; Name: WASH and Nutrition; Assigned to Arm(s): WASH and Nutrition
D: Arm Label: Water Quality; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Water Quality | Arm Label: Sanitation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Sanitation | Arm Label: Handwashing; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Handwashing | Arm Label: Combined Water, Sanitation, and Handwashing; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Water Quality, Behavioral: Sanitation, Behavioral: Handwashing | Arm Label: Nutrition; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Nutrition | Arm Label: Nutrition + Combined Water, Sanitation, and Handwashing; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Water Quality, Behavioral: Sanitation, Behavioral: Handwashing, Dietary Supplement: Nutrition | Arm Label: Active control arm; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Passive control arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Water Quality; Assigned to Arm(s): Combined Water, Sanitation, and Handwashing, Nutrition + Combined Water, Sanitation, and Handwashing, Water Quality | Intervention Type: BEHAVIORAL; Name: Sanitation; Assigned to Arm(s): Combined Water, Sanitation, and Handwashing, Nutrition + Combined Water, Sanitation, and Handwashing, Sanitation | Intervention Type: BEHAVIORAL; Name: Handwashing; Assigned to Arm(s): Combined Water, Sanitation, and Handwashing, Handwashing, Nutrition + Combined Water, Sanitation, and Handwashing | Intervention Type: DIETARY_SUPPLEMENT; Name: Nutrition; Assigned to Arm(s): Nutrition, Nutrition + Combined Water, Sanitation, and Handwashing

Answer: B