NCT02597608

Brief Summary

This is a randomized study in three areas of Bangladesh (Chars region where CLP operates, Haor region where Shiree operates, and urban slums where UPPR operates). Treatment is assigned at the community level, where treatments are:

  • Livelihoods intervention only (L only)
  • Livelihoods intervention plus nutrition intervention (L+N) In UPPR only, the study also includes a non-randomly selected comparison group (C). Within treatment localities, targeted beneficiaries include women, adolescent girls, and children under 24 months. Benefits are received for two years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11,340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

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

July 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 15, 2016

Status Verified

November 1, 2015

Enrollment Period

2.7 years

First QC Date

October 28, 2015

Last Update Submit

September 13, 2016

Conditions

Outcome Measures

Primary Outcomes (23)

  • Child anthropometry - height for age

    Height for age z scores. Outcomes specified in terms of levels two years after intervention started, as well as in changes (2013-2015).

    Baseline. Up to 24 months.

  • Child food intake - number unique foods

    Number of unique foods consumed in previous 24 hours. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Dietary diversity of index child's mother, father, and of adolescent girl - unique foods

    Number of unique foods consumed in previous 24 hours. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Index child mother's nutrition knowledge

    Knowledge (total score) of index child's mother regarding questions on breastfeeding, complementary feeding, nutrition, and sanitation practices (29 questions). Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Household food security - food groups

    Food groups consumed by household in previous seven days. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Infant and young child feeding practices - breastfeeding

    Length of breastfeeding of index child. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Receipt of and participation in livelihoods and nutrition interventions (take up)

    Whether received livelihoods and nutrition interventions carried out by CLP/Shiree/UPPR programmes. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Community nutrition worker knowledge and activities.

    Misconceptions regarding nutrition knowledge and attitudes (regarding breastfeeding, complementary feeding, and sanitation knowledge). Outcomes specified in terms of levels two years after intervention started.

    Up to 24 months.

  • Child anthropometry - weight for age

    Weight for age z scores. Outcomes specified in terms of levels two years after intervention started, as well as in changes (2013-2015).

    Baseline. Up to 24 months.

  • Child anthropometry - stunting

    Percentage of children 0-24 stunted. Outcomes specified in terms of levels two years after intervention started, as well as in changes (2013-2015).

    Baseline. Up to 24 months.

  • Child anthropometry - wasting

    Percentage of children 0-24 wasted. Outcomes specified in terms of levels two years after intervention started, as well as in changes (2013-2015).

    Baseline. Up to 24 months.

  • Child food intake - number food groups

    Number of food groups consumed in previous 24 hours. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Child food intake - food groups

    Consumption of specific food groups (animal source foods, dairy, vitamin A rich foods, etc.) in previous 24 hours. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months

  • Child food intake - caloric consumption

    Caloric consumption in previous 24 hours. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Dietary diversity of index child's mother, father, and of adolescent girl

    Number of food groups consumed in previous 24 hours. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Household food security - unique foods

    Number of unique foods consumed in previous seven days. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Household food security - number of food groups

    Number of food groups consumed in previous seven days weighted by nutritional value and frequency of consumption. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Household food security - value of consumption

    Value of food consumption in previous seven days. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Household food security - caloric availability

    Household caloric availability in previous seven days. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Infant and young child feeding practices - complementary feeding

    Age complementary feeding initiated. Outcomes specified in terms of levels two years after intervention started, and as changes (2013-2015).

    Baseline. Up to 24 months.

  • Community nutrition worker knowledge and activities

    Number of home visits and group training sessions in past month. Outcomes specified in terms of levels two years after intervention started.

    Up to 24 months.

  • Child anthropometry - weight for height

    Weight for height z scores. Outcomes specified in terms of levels two years after intervention started, as well as in changes (2013-2015).

    Baseline. Up to 24 months.

  • Women's BMI

    Body mass index of index child's mother. Weight for height z scores. Outcomes specified in terms of levels two years after intervention started, as well as in changes (2013-2015).

    Baseline. Up to 24 months.

Secondary Outcomes (16)

  • Nutrition knowledge of adolescent girl

    Baseline. Up to 24 months.

  • Health of index child <36 months - child ill

    Baseline. Up to 24 months.

  • Antenatal care - attendance

    Baseline. Up to 24 months.

  • Sanitation practices for index child

    Baseline. Up to 24 months.

  • Women's status index

    Baseline. Up to 24 months.

  • +11 more secondary outcomes

Study Arms (7)

UPPR: Control

EXPERIMENTAL

No interventions are provided.

Other: UPPR: Control

UPPR: Livelihoods only

EXPERIMENTAL

Livelihoods programmes offered by UPPR.

Behavioral: UPPR: Livelihoods

UPPR: Livelihoods plus nutrition

EXPERIMENTAL

Livelihoods programmes offered by UPPR, plus nutrition programmes offered by UPPR.

Behavioral: UPPR: LivelihoodsDietary Supplement: UPPR: Nutrition

CLP: Livelihoods only

EXPERIMENTAL

Livelihoods programmes offered by CLP.

Behavioral: CLP: Livelihoods

CLP: Livelihoods plus nutrition

EXPERIMENTAL

Livelihoods programmes offered by CLP, plus nutrition programmes offered by CLP.

Behavioral: CLP: LivelihoodsDietary Supplement: CLP: Nutrition

Shiree: Livelihoods only

EXPERIMENTAL

Livelihoods programmes offered by Shiree.

Behavioral: Shiree: Livelihoods

Shiree: Livelihoods plus nutrition

EXPERIMENTAL

Livelihoods programmes offered by Shiree, plus nutrition programmes offered by Shiree.

Behavioral: Shiree: LivelihoodsDietary Supplement: Shiree: Nutrition

Interventions

Capital for purchase of income generating asset, physical infrastructure (plinths, latrines, tubewells), livelihood maintenance stipend, monthly asset maintenance cost stipend, agricultural livelihood training, non-agricultural livelihood training, financial training, health and nutrition training.

CLP: Livelihoods onlyCLP: Livelihoods plus nutrition
CLP: NutritionDIETARY_SUPPLEMENT

Counseling on breastfeeding and complementary feeding; five components micronutrients (iron 12.5 mg, folic acid 0.16 mg, zinc 5 mg, vitamin A 0.3 mg, vitamin C 30 mg) for children 7-23 months dosage of 120 sachets per year; 180 iron and folic acid tablets (60 mg iron and 400 mg folic acid) tablets to each pregnant woman after first trimester and up to 180 for each breastfeeding woman per year, as well as 104 tablets to each adolescent girl; deworming treatment for children aged 1-5 years, adolescent girls, pregnant women after first trimester; identification and referral of acute malnutrition; facilitation of government campaigns on nutrition.

CLP: Livelihoods plus nutrition

Financial training; input support for livelihoods (cropping, livestock, poultry, fishing, bamboo working, small businesses, tailoring etc.); capacity building (mobilising Self Help Groups, facilitating community based organizations (CBOs), skills transfer); innovation support (market linkage and access to value chains); credit and savings groups; support in mobilizing communities to advocate for their needs.

Shiree: Livelihoods onlyShiree: Livelihoods plus nutrition
Shiree: NutritionDIETARY_SUPPLEMENT

Counseling on breastfeeding, complementary feeding, and sanitation; community discussions including adolescent girls on early and forced marriage; five components micronutrients (iron 12.5 mg, folic acid 0.16 mg, zinc 5 mg, vitamin A 0.3 mg, vitamin C 30 mg) for children aged 7-23 months; 180 iron and folic acid tablets (60 mg iron and 400 mg folic acid) tablets to each pregnant woman after first trimester and up to 180 for each breastfeeding woman per year, as well as 104 tablets to each adolescent girl; deworming treatment for children aged 1-5 years, adolescent girls, pregnant women after first trimester.

Shiree: Livelihoods plus nutrition

Monetary support for communities to improve infrastructure (drains, footpaths, latrines and water dwells, access to roads and markets); financing for apprenticeships; grants for small businesses; education grants for girls; grants for urban food production activities; financial training; establishment of savings and credit groups; support for communities in advocating for their needs; microcredit; improving access to health facilities; improving housing conditions; provision of plinths.

UPPR: Livelihoods onlyUPPR: Livelihoods plus nutrition
UPPR: NutritionDIETARY_SUPPLEMENT

Counseling on breastfeeding, complementary feeding, and sanitation; community discussions including adolescent girls on early and forced marriage; five components micronutrients (iron 12.5 mg, folic acid 0.16 mg, zinc 5 mg, vitamin A 0.3 mg, vitamin C 30 mg) for children aged 7-23 months; 180 iron and folic acid tablets (60 mg iron and 400 mg folic acid) tablets to each pregnant woman after first trimester and up to 180 for each breastfeeding woman per year, as well as 104 tablets to each adolescent girl; deworming treatment for children aged 1-5 years, adolescent girls, pregnant women after first trimester.

UPPR: Livelihoods plus nutrition

No interventions provided.

UPPR: Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children (boys and girls) 0-36 months
  • Pregnant and breastfeeding women
  • Adolescent girls (aged 13-19)
  • Households must meet eligibility criteria of each of the three programmes (CLP, Shiree, UPPR) except for the control group in UPPR.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Food Policy Research Institute

Dhaka, Bangladesh

Location

Related Publications (5)

  • Smith, L. C., U. Ramakrishnan, A. Ndiaye, L. Haddad, and R. Martorell. 2002. "The Asian Engima. Chapter 7 of The Importance of Women's Status for Child Nutrition in Developing Countries. Research Report 131. Washington, DC: International Food Policy Research Institute.

    BACKGROUND
  • Ramalingaswami, V., U. Jonsson, and J. Rohde. 1996. "Commentary: The Asian Enigma." In The Progress of Nations. New York: UNICEF.

    BACKGROUND
  • Deaton, A., and J. Dreze. 2009.

    BACKGROUND
  • 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: 23746776BACKGROUND
  • Hoddinott J, Behrman JR, Maluccio JA, Melgar P, Quisumbing AR, Ramirez-Zea M, Stein AD, Yount KM, Martorell R. Adult consequences of growth failure in early childhood. Am J Clin Nutr. 2013 Nov;98(5):1170-8. doi: 10.3945/ajcn.113.064584. Epub 2013 Sep 4.

    PMID: 24004889BACKGROUND

Study Officials

  • John Hoddinott, DPhil

    Cornell University

    PRINCIPAL INVESTIGATOR
  • Shalini Roy, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR
  • Naureen Karachiwalla, DPhil

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR
  • Firdousi Naher, PhD

    University of Dhaka

    PRINCIPAL INVESTIGATOR
  • Nick Nisbett, PhD

    Institute for Development Studies, University of Sussex

    PRINCIPAL INVESTIGATOR
  • Jean Pierre Tranchant, PhD

    Institute for Development Studies, University of Sussex

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 5, 2015

Study Start

July 1, 2013

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

September 15, 2016

Record last verified: 2015-11

Locations