NCT03024710

Brief Summary

Infant feeding practices and nutritional status among children is interrelated and link is well established. Incidence of malnutrition sharply rises during 6-9 months of age in most of the developing countries which coincide with the period of complimentary feeding (CF). This prospective randomized trial will be implemented in ongoing health and demographic surveillance system of Matlab, ICDDR,B and will be nested into an ongoing maternal and child health services area. Area of community health workers (four blocks) will be divided into two pairs and each pair will be randomly assigned into intervention or control groups. The eligible and consented mother-infant newborn will be recruited either into an intervention or control groups based on the areas of the paired block. The mothers and family members of the intervention area will receive intensive counseling on complementary feeding practices through community health workers. In total about 360 mother-infant pair will be recruited in the study for each site. Data on children's anthropometry (weight and lengths), information on complementary feeding practices and related covariates will be collected through trained research staffs. Data will be evaluated on reduction of burden of malnutrition (stunting, underweight, wasting) and complimentary feeding index between intervention and control groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

September 6, 2016

Last Update Submit

January 19, 2017

Conditions

Keywords

Stuntingcomplementary feeding IndexBangladesh

Outcome Measures

Primary Outcomes (3)

  • Length for age of the infant between two areas ( less than -2SD according National intervention group) will be measured

    Stunting will be calculated as length for age of the infant less than -2SD according National Center for Heath Statics.

    6 months

  • weight for length of the infant between two areas ( less than -2SD according National intervention group) will be measured

    Wasting will be calculated as weight for length of the infant less than -2SD according National Center for Heath Statics.

    6 months

  • weight for age of the infant between two areas ( less than -2SD according National intervention group) will be measured

    Underweight will be calculated as weight for age of the infant less than -2SD according National Center for Heath Statics.

    6 months

Secondary Outcomes (1)

  • Difference in complementary feeding index among the intervention and control group

    6 months

Study Arms (2)

Intervention cluster

EXPERIMENTAL

The study participants (the infant who has completed his/her 6 month of age from the date of birth along with their mother) will be enrolled from MNCH database according to criteria for the intervention group.All the mothers of the selected infants along with family member/s will receive training on standard complementary feeding practices . Refresher training will be arranged 3 months after the first training. The CHRW will visit each infant house till the infant reaches at 12 month of age at every two month interval. During the visit CHRWs will measure weight through standard SECA digital weighing scale in nearest 100 gm (precision 20 gram) and length in nearest 0.1 cm by local made standard length board with movable foot board.

Behavioral: Intervention cluster

Controlled cluster

NO INTERVENTION

The participants for control clusters will be (the infant who has completed his/her 6 month of age from the date of birth along with their mother) will be enrolled from MNCH database according to criteria. The mother-infant pairs from control cluster will receive the usual care.

Interventions

The mother- infant pairs (the infant who has completed his/her 6 month of age from the date of birth along with their mother) of intervention clusters will receive the CF practice counselling in groups as soon as enrolment is completed by CHRW at fixed site clinic and refreshers will be arranged 3 months apart from first training in groups at same place and by same person. However CHRWs will also counsel each participant during her bimonthly household visit.

Intervention cluster

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The infant who has completed his/her 6 month of age from the date of birth along with their mother

You may not qualify if:

  • Children with severe illnesses or handicaps affecting development, feeding, or activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matlab

Chāndpur, Bangladesh

Location

Related Publications (20)

  • Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.

    PMID: 8594834BACKGROUND
  • Brown K, Dewey KG, Allen H. Complementary feeding of young children in developing countries: a review of current scientific knowledge. Geneva: World Health Organization, 1998:1544. (WHO/NUT/98.1)

    BACKGROUND
  • World Health Organization. Complementary feeding: report of global consultation, 10-13 December 2001 and summary of guiding principles. Geneva: World Health Organization, 2001:920

    BACKGROUND
  • Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.

    PMID: 18207566BACKGROUND
  • Pollitt E, Gorman KS, Engle PL, Rivera JA, Martorell R. Nutrition in early life and the fulfillment of intellectual potential. J Nutr. 1995 Apr;125(4 Suppl):1111S-1118S. doi: 10.1093/jn/125.suppl_4.1111S.

    PMID: 7536831BACKGROUND
  • Grantham-McGregor SM, Cumper G. Jamaican studies in nutrition and child development, and their implications for national development. Proc Nutr Soc. 1992 May;51(1):71-9. doi: 10.1079/pns19920012.

    PMID: 1380717BACKGROUND
  • Haas JD, Murdoch S, Rivera J, Martorell R. Early nutrition and later physical work capacity. Nutr Rev. 1996 Feb;54(2 Pt 2):S41-8. doi: 10.1111/j.1753-4887.1996.tb03869.x.

    PMID: 8710235BACKGROUND
  • Jones G, Steketee RW, Black RE, Bhutta ZA, Morris SS; Bellagio Child Survival Study Group. How many child deaths can we prevent this year? Lancet. 2003 Jul 5;362(9377):65-71. doi: 10.1016/S0140-6736(03)13811-1.

    PMID: 12853204BACKGROUND
  • Mitra SN, Ahmed Al Sabir, Anne RC, Kanta J. Bangladesh Demography And Health Survey 2007. Dhaka And Calverton, Maryland: National Institute Of Population Research And Training (NIPORT), Mitra & Associates, And Macro International Inc., 2007.

    BACKGROUND
  • Millennium Development Goals: Bangladesh Progress Report. February 2005. Jointly prepared by the Government of Bangladesh and the United Nations Country Team in Bangladesh

    BACKGROUND
  • National Institute of Population Research and Training. Bangladesh demographic and health survey 2004. Dhaka: National Institute of Population Research and Training, 2005. 339 p.

    BACKGROUND
  • The State of the World's Breastfeeding: Bangladesh report card:2005 International Baby Food Action Network (IBFAN), Asia Pacific.

    BACKGROUND
  • Bhandari N, Mazumder S, Bahl R, Martines J, Black RE, Bhan MK; Infant Feeding Study Group. An educational intervention to promote appropriate complementary feeding practices and physical growth in infants and young children in rural Haryana, India. J Nutr. 2004 Sep;134(9):2342-8. doi: 10.1093/jn/134.9.2342.

    PMID: 15333726BACKGROUND
  • Guldan GS, Fan HC, Ma X, Ni ZZ, Xiang X, Tang MZ. Culturally appropriate nutrition education improves infant feeding and growth in rural Sichuan, China. J Nutr. 2000 May;130(5):1204-11. doi: 10.1093/jn/130.5.1204.

    PMID: 10801920BACKGROUND
  • Santos I, Victora CG, Martines J, Goncalves H, Gigante DP, Valle NJ, Pelto G. Nutrition counseling increases weight gain among Brazilian children. J Nutr. 2001 Nov;131(11):2866-73. doi: 10.1093/jn/131.11.2866.

    PMID: 11694610BACKGROUND
  • Brown LV, Zeitlin MF, Peterson KE, Chowdhury AM, Rogers BL, Weld LH, Gershoff SN. Evaluation of the impact of weaning food messages on infant feeding practices and child growth in rural Bangladesh. Am J Clin Nutr. 1992 Dec;56(6):994-1003. doi: 10.1093/ajcn/56.6.994.

    PMID: 1442668BACKGROUND
  • Resource Book, National Nutrition Programme, Health Nutrition and population Sector Programme (HNPSP), Ministry of Health and Family Welfare, 2009

    BACKGROUND
  • Pan American Health Organization. Guiding principles for complementary feeding of breastfed child. Washington, DC: Pan American Health Organization,2003:8-26.

    BACKGROUND
  • Roy SK, Jolly SP, Shafique S, Fuchs GJ, Mahmud Z, Chakraborty B, Roy S. Prevention of malnutrition among young children in rural Bangladesh by a food-health-care educational intervention: a randomized, controlled trial. Food Nutr Bull. 2007 Dec;28(4):375-83. doi: 10.1177/156482650702800401.

    PMID: 18274163BACKGROUND
  • Rahman A, Bhuiyan MB, Das SK. Effect of short-term educational intervention on complementary feeding index among infants in rural Bangladesh: a randomized control trial. BMC Nutr. 2022 Aug 2;8(1):73. doi: 10.1186/s40795-022-00565-0.

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aminur Rahman, MBBS, MSc

    ICDDR,B, Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

January 19, 2017

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

As per icddr,b data policy study data will be shared with research administration for use future by others after following legal permission

Locations