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Trial record 1 of 1 for:    NCT02768181
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Evaluate Bundling of Nutrition Interventions

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Department for International Development, United Kingdom
International Food Policy Research Institute
University of Sydney
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT02768181
First received: May 2, 2016
Last updated: December 11, 2016
Last verified: April 2016
  Purpose

Background:

  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. 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. 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.

Hypothesis: Five selected nutrition-specific interventions implemented during early pregnancy and during first two years of child's life in different bundles will cause a shift of 0.4 in mean HAZ score among children at 24 months of age compared to those in comparison arm.

Methods: The investigators propose a community-based randomized trial (CRCT) to evaluate the effectiveness of different combinations of the five selected nutrition-specific interventions and identify the best combination for improving childhood HAZ. Selected interventions include prenatal nutrition supplementation; intensive counselling on prenatal nutrition, exclusive breastfeeding and timely complementary feeding; and complementary food supplementation during 6-23 months. The proposed study area is Habiganj district, Sylhet division. 125 clusters (each ~2000 population or ~450 households) will be selected from 12 homogenous unions in 2 adjacent sub-districts. The clusters will then be randomly assigned to any one of the 5 study arms. Data would be collected at baseline and followed up, including on nutritional intake and anthropometric measurements of mothers and offspring. Primary outcome measure/variable would be mean HAZ of offspring at 24 months. Secondary outcome variables include nutritional intake during pregnancy, maternal weight gain, exclusive breast feeding up-to 6 months, and birth weight.

Implications: The investigators expect that the results will serve to inform and shape future health policy decisions related to promotion of maternal and child health.


Condition Intervention
Stunting in Under-2 Children
Behavioral: Nutrition-specific Behaviour change communication (BCC)
Dietary Supplement: Nutritional supplement to pregnant women
Dietary Supplement: Nutritional supplement to children 6m to 2 years

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Community-based Cluster Randomized 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

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • 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. [ Time Frame: ~125 days of gestation to 2 years of child's age: 41 months ]

Secondary Outcome Measures:
  • Nutritional intake (energy and protein) of pregnant women in intervention and comparison arms [ Time Frame: ~125 days of gestation till birth delivery ]
    Method of outcome assessment: 24-hour dietary recall method (FAO guideline based)

  • Early initiation of breastfeeding in intervention and comparison arms [ Time Frame: Birth delivery ]
    Method of outcome assessment: Questionnaire at 24 hours and 7 days of birth (WHO guideline based, Bangladesh Demographic & Health Survey validated)

  • Exclusive breastfeeding (EBF) rates up-to six months in intervention and comparison arms [ Time Frame: Birth delivery to 6 months of child's age (180 days) ]
  • Maternal weight gain during pregnancy in intervention and comparison arms [ Time Frame: ~125 days of gestation till birth delivery ]
  • Birth weight of live newborns in intervention compared to comparison clusters [ Time Frame: Birth delivery ]

Estimated Enrollment: 2550
Study Start Date: November 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BCC+PNS+CNS
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 nutritional supplement to pregnant women 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 nutritional supplement to children 6m to 2 years.
Behavioral: Nutrition-specific Behaviour change communication (BCC)
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.
Dietary Supplement: Nutritional supplement to pregnant women

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.

Dietary Supplement: Nutritional supplement to children 6m to 2 years

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.

Experimental: Arm 2: BCC+PNS
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 nutritional supplement to pregnant women 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)
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.
Dietary Supplement: Nutritional supplement to pregnant women

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.

Experimental: Arm 3: BCC+CNS
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 nutritional supplement to children 6m to 2 years.
Behavioral: Nutrition-specific Behaviour change communication (BCC)
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.
Dietary Supplement: Nutritional supplement to children 6m to 2 years

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.

Experimental: Arm 4: BCC only
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)
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.
No Intervention: Arm 5: comparison
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02768181

Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Department for International Development, United Kingdom
International Food Policy Research Institute
University of Sydney
  More Information

Publications:

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02768181     History of Changes
Other Study ID Numbers: PR-14124
Study First Received: May 2, 2016
Last Updated: December 11, 2016

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
nutrition-specific behaviour change communication
dietary supplements

Additional relevant MeSH terms:
Vitamins
Vitamin A
Folic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamin B Complex

ClinicalTrials.gov processed this record on May 22, 2017