Evaluating Bundling of Nutrition-specific Interventions

NCT02768181 | Completed

• 1 other identifier: PR-14124
• Study Type: interventional
• Target: 2,880
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

1. 1.Burden: The prevalence of stunting among the under-five children in Bangladesh was \>55% in 1997, which reduced to 41.9% in 2011. This reduction took 14 years to achieve with existing interventions, and till today Bangladesh remains among the countries with the highest stunting prevalence.
2. 2.Knowledge gap: In the Lancet series on Maternal and Child Nutrition, Bhutta et al (2013) modelled the effect of 10 direct interventions on lives saved and economic costs in 34 countries which contains 90% of the children with stunted growth. Their findings suggested that at 90% coverage, these interventions could cut down under-5 year mortality by 15% and avert one-fifth of stunting. The total additional annual cost was estimated at $9.6 billion. There is a dearth of primary research, however, to determine a feasible, effective bundle of interventions for developing countries.
3. 3.Relevance: This study will review and test different sets of nutrition-specific intervention bundles in a cohort of pregnant women and the subsequent impact on the length-for-age Z score (LAZ) of their offspring from that pregnancy.

Conditions

Stunting in Under-2 Children

Keywords

nutrition-specific behaviour change communication; dietary supplements

Outcome Measures

Primary Outcomes (1)

• Change in Length-for-age Z scores (LAZ) at 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline LAZ at 7 days of birth.

  Method of outcome assessment: Length measurement of study child

  1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age

Secondary Outcomes (8)

• Nutritional intake (energy and protein) of pregnant women in intervention and comparison arms

  ~125 days of gestation till birth delivery

• Early initiation of breastfeeding in intervention and comparison arms

  Birth delivery

• Exclusive breastfeeding (EBF) rates up-to six months in intervention and comparison arms

  Birth delivery to 6 months of child's age (180 days)

• Maternal weight gain during pregnancy in intervention and comparison arms

  ~125 days of gestation till birth delivery

• Birth weight of live newborns in intervention compared to comparison clusters

  Birth delivery

Study Arms (5)

Arm 1: BCC+PNS+CNS

EXPERIMENTAL

Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth, along with a lipid-based nutrient supplement to pregnant women (PNS) till delivery. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children, along with a lipid-based nutrient supplement for children (CNS) aged 6m to 2 years.

Behavioral: Nutrition-specific Behaviour change communication (BCC); Dietary Supplement: Nutrient supplement to pregnant women (PNS); Dietary Supplement: Nutrienr supplement to children 6m to 2 years

Arm 2: BCC+PNS

EXPERIMENTAL

Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth, along with nutrient supplement to pregnant women (PNS) till delivery. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children.

Behavioral: Nutrition-specific Behaviour change communication (BCC); Dietary Supplement: Nutrient supplement to pregnant women (PNS)

Arm 3: BCC+CNS

EXPERIMENTAL

Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children, along with nutrient supplement to children (CNS) 6m to 2 years.

Behavioral: Nutrition-specific Behaviour change communication (BCC); Dietary Supplement: Nutrienr supplement to children 6m to 2 years

Arm 4: BCC only

EXPERIMENTAL

Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children.

Behavioral: Nutrition-specific Behaviour change communication (BCC)

Arm 5: comparison

NO INTERVENTION

No intervention will be provided by the study. The existing services delivered though government health systems will be continued. Government /NGO-led routine counseling and supplementary services available at Upazila and union levels, which include prenatal counseling, exclusive breastfeeding counseling, and maternal iron-folic acid supplementation and vitamin-A supplementation for children will continue. However, assessment of outcomes will be conducted in same frequency and schedule, alike in intervention arms, described in data collection section.

Interventions

Nutrition-specific Behaviour change communication (BCC) BEHAVIORAL

Door-to-door counseling on nutrition during pregnancy and exclusive breastfeeding from enrolment into study till birth; exclusive breastfeeding and nutrition of lactating mothers during post-natal 6 months; timely and appropriate complementary feeding with continued breastfeeding until 2 years of child's age, and nutrition of lactating mothers during post-natal 6-24 months; all counseling would be supplemented with associated issues including hygiene and sanitation, mother's sleep and rest, maternal and child healthcare seeking etc.

Arm 1: BCC+PNS+CNS; Arm 2: BCC+PNS; Arm 3: BCC+CNS; Arm 4: BCC only

Nutrient supplement to pregnant women (PNS) DIETARY_SUPPLEMENT

A lipid-based micronutrient supplement (LNS) is packed in \~10g sachets. Formulation: Vegetable fat (soy), skimmed milk powder, peanuts, vitamin and mineral complex, sugar, stabilizer: fully hydrogenated vegetable fat, and antioxidant : tocopherols. Each sachet contains 70-75% of recommended dietary allowance for most of the micronutrients, including iron, folic acid, zinc, calcium, iodine, vitamins A, B1, B2, niacin, B12 etc. Dose: 1 sachet/pregnant woman/day starting from the first counseling session (GA \~125∓15 days) continued till birth of baby. Supplement should be taken with food in room temperature, and must not be heated, or mixed with hot food. To avoid overdose, respondents receiving this supplement should stop taking any other micronutrient supplement or drink.

Arm 1: BCC+PNS+CNS; Arm 2: BCC+PNS

Nutrienr supplement to children 6m to 2 years DIETARY_SUPPLEMENT

A lipid-based micronutrient supplement (LNS) is packed in \~10g sachets. Formulation: Vegetable fat, skimmed milk powder, peanuts, sugar, vitamin and mineral complex, maltodextrin, and emulsifier: lecithin. Each sachet contains 70-75% of recommended dietary allowance for most of the micronutrients, including iron, folic acid, zinc, calcium, iodine, vitamins A, B1, B2, niacin, B12 etc. Each 20 g of LNS provide ≥4.46g LA (Linoleic Acid) and ≥0.42g ALA (α-Linolenic Acid). Dose: 2 sachets \~(10+10=20g)/child/day from 5th completed months (181 days) to 24 completed months of child's age. Supplement should be taken with food in room temperature, and must not be heated, or mixed with hot food. Supplement should be taken with food in room temperature, and must not be heated, or mixed with hot food. To avoid overdose, respondents receiving this supplement should stop taking any other micronutrient supplement or drink.

Arm 1: BCC+PNS+CNS; Arm 3: BCC+CNS

Eligibility Criteria

• Age: Up to 49 Years
• Gender Eligibility Details: Only pregnant mothers will be female, all resultant study children were eligible to be recruited regardless of gender
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All new pregnancies in the selected clusters
• Eligible woman is resident of the study area
• Gestational age ≤125 days
• Possible pregnant woman can identify her last menstrual period (LMP)

You may not qualify if:

• Similar nutrition interventions currently being implemented by either public or non-government agency in the selected cluster
• The cluster is too hard to reach and accessibility of the cluster is highly constrained by geographical impediments
• The cluster includes tea gardens. Communities in tea gardens comprise of unique ethnicity, culture and lifestyle for which our intervention is not customized

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Department for International Development, United Kingdom: collaborator
• International Food Policy Research Institute: collaborator
• University of Sydney: collaborator
• Swedish International Development Cooperation Agency (SIDA): collaborator

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (16)

• Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6.

  PMID: 23746776 BACKGROUND

• Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

  PMID: 23746772 BACKGROUND

• Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.

  PMID: 22579125 BACKGROUND

• Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M; Maternal and Child Undernutrition Study Group. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. doi: 10.1016/S0140-6736(07)61693-6.

  PMID: 18206226 BACKGROUND

• Kar BR, Rao SL, Chandramouli BA. Cognitive development in children with chronic protein energy malnutrition. Behav Brain Funct. 2008 Jul 24;4:31. doi: 10.1186/1744-9081-4-31.

  PMID: 18652660 BACKGROUND

• Martorell R, Horta BL, Adair LS, Stein AD, Richter L, Fall CH, Bhargava SK, Biswas SK, Perez L, Barros FC, Victora CG; Consortium on Health Orientated Research in Transitional Societies Group. Weight gain in the first two years of life is an important predictor of schooling outcomes in pooled analyses from five birth cohorts from low- and middle-income countries. J Nutr. 2010 Feb;140(2):348-54. doi: 10.3945/jn.109.112300. Epub 2009 Dec 9.

  PMID: 20007336 BACKGROUND

• Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4.

  PMID: 17208643 BACKGROUND

• Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008 Jan 26;371(9609):340-57. doi: 10.1016/S0140-6736(07)61692-4.

  PMID: 18206223 BACKGROUND

• Thomas D, Strauss J. Health and wages: evidence on men and women in urban Brazil. J Econom. 1997;77:159-85. doi: 10.1016/s0304-4076(96)01811-8.

  PMID: 12292719 BACKGROUND

• Imdad A, Bhutta ZA. Effects of calcium supplementation during pregnancy on maternal, fetal and birth outcomes. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:138-52. doi: 10.1111/j.1365-3016.2012.01274.x.

  PMID: 22742607 BACKGROUND

• Lassi ZS, Das JK, Zahid G, Imdad A, Bhutta ZA. Impact of education and provision of complementary feeding on growth and morbidity in children less than 2 years of age in developing countries: a systematic review. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S13. doi: 10.1186/1471-2458-13-S3-S13. Epub 2013 Sep 17.

  PMID: 24564534 BACKGROUND

• Mangasaryan N, Martin L, Brownlee A, Ogunlade A, Rudert C, Cai X. Breastfeeding promotion, support and protection: review of six country programmes. Nutrients. 2012 Aug;4(8):990-1014. doi: 10.3390/nu4080990. Epub 2012 Aug 14.

  PMID: 23016128 BACKGROUND

• Baqui AH, El-Arifeen S, Darmstadt GL, Ahmed S, Williams EK, Seraji HR, Mannan I, Rahman SM, Shah R, Saha SK, Syed U, Winch PJ, Lefevre A, Santosham M, Black RE; Projahnmo Study Group. Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomised controlled trial. Lancet. 2008 Jun 7;371(9628):1936-44. doi: 10.1016/S0140-6736(08)60835-1.

  PMID: 18539225 BACKGROUND

• Akter SM, Roy SK, Thakur SK, Sultana M, Khatun W, Rahman R, Saliheen SS, Alam N. Effects of third trimester counseling on pregnancy weight gain, birthweight, and breastfeeding among urban poor women in Bangladesh. Food Nutr Bull. 2012 Sep;33(3):194-201. doi: 10.1177/156482651203300304.

  PMID: 23156122 BACKGROUND

• Ara G, Sanin KI, Khanam M, Sarker SA, Khan SS, Rifat M, Chowdhury IA, Askari S, Afsana K, Ahmed T. Study protocol to assess the impact of an integrated nutrition intervention on the growth and development of children under two in rural Bangladesh. BMC Public Health. 2019 Nov 1;19(1):1437. doi: 10.1186/s12889-019-7777-y.

  PMID: 31675943 DERIVED

• Billah SM, Ferdous TE, Karim MA, Dibley MJ, Raihana S, Moinuddin M, Choudhury N, Ahmed T, Hoque DME, Menon P, Arifeen SE. A community-based cluster randomised controlled trial to evaluate the effectiveness of different bundles of nutrition-specific interventions in improving mean length-for-age z score among children at 24 months of age in rural Bangladesh: study protocol. BMC Public Health. 2017 May 2;17(1):375. doi: 10.1186/s12889-017-4281-0.

  PMID: 28464867 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 11, 2016
• Study Start: November 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 22, 2019

Record last verified: 2018-03

Locations

BA (1)