Effectiveness of LNS and MNP Supplements to Prevent Malnutrition in Women and Their Children in Bangladesh
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The program effectiveness study aims to assess the effect of a lipid-based nutrition
      supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for
      improving maternal nutritional status during pregnancy and lactation (LNS only), and
      preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.
    

Detailed description: 
      This study is a cluster-randomized controlled trial with four study "arms", implemented
      within the context of the Community Health and Development Program (CHDP) run by the World
      Mission Prayer League, which also has a hospital in the area and is known as LAMB. Data
      collection is longitudinal, starting with the identification of women in early pregnancy who
      are eligible to enter the study, and continuing, with follow-up of the child, until 24 months
      post-partum. A final follow-up visit will occur when the child is 36 months old to update
      contact information; no outcomes data will be collected at that final visit. The
      investigators are evaluating the effect of providing LNS-PLW to mothers during pregnancy and
      lactation on maternal health and nutrition outcomes (including anthropometric and
      micronutrient status), morbidity and birth outcomes in comparison to mothers who receive
      iron-folic acid tablets during pregnancy and lactation. The investigators are also evaluating
      the effect of three different home-fortification approaches (arms a-c, below) on child health
      and nutrition outcomes including anthropometric status, micronutrient status, anemia, and
      motor and cognitive development, in comparison to a control arm not receiving a home
      fortification intervention.

      Additionally, the cost of implementation and delivery of the LNS-PLW, LNS-child or MNP
      interventions as part of the CHDP compared to standard CHDP program delivery will be
      documented. Willingness to pay (private demand) for LNS-PLW, LNS-child and MNP products by
      selected caregivers and male heads of households will be assessed at baseline and again at
      various points during the intervention period.

      A process evaluation of the LNS and MNP interventions, and of the services provided to the
      control group, within the CHDP will be conducted to: 1) Document and evaluate the processes
      needed for implementation of interventions that provide a nutrient supplement such as LNS or
      MNP in the context of the CHDP; and 2) Explain and interpret program effectiveness study
      results and identify important facilitators and barriers to success of the nutrition
      intervention, which can be used to improve the effectiveness of current CHDP programs and
      future similar programs that include the scaling-up of LNS or MNP.

      A post-intervention follow-up assessment for participants in the RDNS trial was added to the
      study protocol in November 2015. The intervention stopped when the study children turned 24
      months old, and follow-up visits to update contact information were conducted when the
      children turned 36 months old. Thereafter, when the study children are between 40 and 52
      months old, the follow-up assessment includes anthropometric and cognitive development
      assessments and collection of blood samples (finger prick, for measurement of hemoglobin) and
      buccal swab samples at the local clinics; for the mothers the follow-up includes
      anthropometric measurements, measurement of blood pressure and collection of fasting blood
      samples (finger prick). The follow-up also includes anthropometric measurements of the
      younger siblings, as well as a home visit to collect information on socioeconomic status,
      food security, hospitalizations of mother or child, developmental stimulation in the home,
      child food preferences and retrospective perceptions about the trial interventions.

      Follow-up outcomes:

      Maternal: Body mass index, skinfold thickness, mid-upper arm circumference, attained height.
      Hemoglobin, anemia, blood pressure, blood lipids, HbA1C.

      Index child: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, skinfold thickness, MUAC, arm
      fat and muscle area. Verbal ability (language), non-verbal ability (visual spatial),
      executive function and pre-academic skills. Hemoglobin, anemia. Hospitalizations since 24
      months of age. Preferences for sweet and fatty foods.

      Younger sibling: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, MUAC.
    

Intervention name(s): LNS-PLW; LNS-Child; MNP; IFA
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement: Lipid-based nutrient supplement
Lipid-based nutrient supplement for pregnant and lactating women (LNS-PLW)
Daily dose of LNS-PLW will be 20 g, packaged in one sachet; Dietary supplement: Lipid-based nutrient supplement
Lipid-based nutrient supplement for infants and young children (LNS-Child)
Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets; Dietary supplement: Micronutrient powder
Micronutrient powder for infants and young children (MNP)
The MNP for children will be packaged in 1 g sachets, so that each day, the child will consume one sachet.; Dietary supplement: Iron and folic acid nutrient supplement
Iron-folic acid tablets for pregnant and lactating women
Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: malnutrition; stunting; LNS; micronutrient powder; hemoglobin