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Trial record 48 of 55 for:    linolenic acid

Evaluating Bundling of Nutrition-specific Interventions

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ClinicalTrials.gov Identifier: NCT02768181
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
Department for International Development, United Kingdom
International Food Policy Research Institute
University of Sydney
Swedish International Development Cooperation Agency (SIDA)
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

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 LAZ 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 LAZ. Selected interventions include prenatal nutrient supplementation; intensive counselling on prenatal nutrition, exclusive breastfeeding and timely complementary feeding; and nutrient supplementation during 6-23 months of child's age. The proposed study area is Habiganj district, Sylhet division. 125 clusters (each ~2000 population or ~450 households) will be selected from 12 homogeneous 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 LAZ 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 or disease Intervention/treatment Phase
Stunting in Under-2 Children 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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2880 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (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
Study Start Date : November 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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)
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: Nutrient supplement to pregnant women (PNS)

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: Nutrienr 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 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)
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: Nutrient supplement to pregnant women (PNS)

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 nutrient supplement to children (CNS) 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: Nutrienr 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.



Primary Outcome Measures :
  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. [ Time Frame: 1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age ]
    Method of outcome assessment: Length measurement of study child


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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) ]
    Method of outcome assessment: 24-hour dietary recall by mother at 1, 2, 3, 4 and 5m of study child's age

  4. Maternal weight gain during pregnancy in intervention and comparison arms [ Time Frame: ~125 days of gestation till birth delivery ]
    Method of outcome assessment: Weight measurement of study mother and calculating weight gain from baseline to 3rd measurement

  5. Birth weight of live newborns in intervention compared to comparison clusters [ Time Frame: Birth delivery ]
    Method of outcome assessment: Weight measurement of study child

  6. IYCF practices (age-appropriate complementary feeding along with continued breastfeeding until postnatal 2 years) among the intervention and comparison arms [ Time Frame: 6, 9, 12, 15, 18, 21 and 24 months of child's age ]
    Method of outcome assessment: 24-hour dietary recall (FAO guideline based) and 7-day food frequency questionnaire method by mother

  7. Change in weight-for-length Z scores (WLZ) at 1, 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline WLZ at 7 days of birth. [ Time Frame: 1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age ]
    Method of outcome assessment: Length and weight measurement of study child

  8. Change in weight-for-age Z scores (WAZ) at 1, 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline WAZ at 7 days of birth. [ Time Frame: 1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age ]
    Method of outcome assessment: Weight measurement of study child



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only pregnant mothers will be female, all resultant study children were eligible to be recruited regardless of gender
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768181


Locations
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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
Swedish International Development Cooperation Agency (SIDA)

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02768181     History of Changes
Other Study ID Numbers: PR-14124
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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