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General

Study Overview

Title:

Effectiveness of an integrated program to reduce maternal and child malnutrition in Indonesia

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-55ad3b0f60c57

Initial Registration Date:

07/20/2015

Last Update Date:

07/17/2015

Study Status:

Ongoing

Location(s):

Indonesia

Abstract:

This project aims to assess the impact of alternative packages of nutrition-specific and nutrition-sensitive interventions on child nutritional status and growth, in comparison with the routine/existing integrated health post (Posyandu) service package in Indonesia. This evaluation takes on a comprehensive approach combining nutrition-specific interventions with nutrition-sensitive interventions in health, hygiene, water and sanitation. The program impact evaluation uses a cluster randomized controlled trial design and will take place in East Java over 2.5 year period. It will include baseline and endline cross sectional surveys to assess the population level impact on childhood stunting and a nested cohort of pregnant women and their young children to assess impact on birthweight and child growth.

Registration Citation:

Dibley, M. and Ariawan, I., 2015. Effectiveness of an integrated program to reduce maternal and child malnutrition in Indonesia. Registry for International Development for Impact Evaluations (RIDIE). Available at: 10.23846/ridie067

Categories:

Health, Nutrition, and Population

Additional Keywords:

Secondary ID Number(s):

30ID02-ML (GAIN)

Principal Investigator(s)

Name of First PI:

Michael Dibley

Affiliation:

The University of Sydney

Name of Second PI:

Iwan Ariawan

Affiliation:

Center for Health Research, University of Indonesia

Intervention

Intervention Overview

Intervention:

The intervention being evaluated is a package of nutrition interventions that includes systematic strengthening community health services with enhanced counseling to support appropriate infant and young child feeding at community and health centre levels; community level behavior change communications including establishment of community working groups and community champions for mobilization; creation of an enabling environment through advocacy, implementation of local breastfeeding code, and involvement of media and other alliances; increased use of water filters to improve water quality, improved distribution of iron and folic acid for pregnant women, and increased accessibility to fortified infant & young child nutrition products. The group receiving the intervention will also receive the usual community health services available. The design of the intervention was informed by situation assessment/mapping and formative research.

Theory of Change:

Multiple Treatment Arms Evaluated?

No

Implementing Agency

Name of Organization:

The University of Sydney

Type of Organization:

Research Institution/University

Program Funder

Type of Organization:

Research Institution/University

Intervention Timing

Intervention or Program Started at time of Registration?

Yes

Start Date:

04/01/2014

End Date:

12/31/2016

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Randomized control trial

Other (not Listed) Method:

Additional Evaluation Method (If Any):

Other (specify)

Other (not Listed) Method:

Qualitative assessment

Method Details

Details of Evaluation Approach:

This study will use a cluster RCT to evaluate the impact of the combined interventions. The clusters will be selected sub-districts in the Malang and Sidoarjo districts, which will be randomly assigned to either the intervention arm consisting of the integrated package of nutrition interventions, or the control arm where routine community health services are being provided. The 12 eligible sub-district clusters are assigned to intervention or control treatment arms using restricted randomization, stratified by district, to ensure overall balance between the groups for a set of key set of indicators and with a uniform allocation ratio of treatment groups. There are two types of outcome assessments: 1) baseline and endline cross sectional surveys to assess the impact of the intervention on stunting prevalence in the study population; and 2) follow-up of a cohort of women and their infants from late in the 3rd trimester until the child is 18 months to examine changes in child growth at the individual level.

Outcomes (Endpoints):

Primary outcome: Differences in stunting (length-for-age less than -2 Z scores (WHO 2006 Child Growth Standard) & mean length-for-age Z scores in children from birth to 24 months between intervention & comparison groups. Secondary outcomes include differences between the two groups as follows: 1) Prevalence of wasting & mean weight-for-length Z scores from 0 to 24 months; 2) Mean length-for-age & weight-for-length Z scores at 18 months; 3) Percent of women initiating breastfeeding (BF) within 1 hour of delivery: 4) Percent of women exclusively BF in children less 6 months, & mean duration of exclusive BF; 5) Percent of children consuming more than 4 food groups & fortified foods; 6) Mean intake of food energy, protein, carbohydrate, fat & selected micronutrients from complementary foods at 9, 12 & 18 months, & the micronutrient density of the diets compared to desired levels; 7) Percent of women at risk of inadequate nutrient intakes; 8) Biochemical iron & zinc status of children & their mothers; 9) Number of events & mean days ill with diarrhea, acute respiratory infection & fever; 10) Average costs of the interventions, & the mean cost per stunted infant prevented.

Unit of Analysis:

The unit of analysis will be the individual mother-infant pairs.

Hypotheses:

Primary hypothesis: In a community-based, cluster RCT of women from 2 districts in Indonesia, integrated nutrition-specific and nutrition-sensitive interventions delivered over 18 months will reduce the prevalence of stunting in children aged 0-24 months by 6% (from 35% in control to 28.9% in intervention) as assessed in before & after cross sectional surveys, compared to areas receiving only routine Posyandu services. Secondary hypotheses: The interventions will: 1) Increase mean length- & weight- for-age Z scores, & mean weight-for-length Z scores at 6 months; 2) Decrease prevalence of low weight-for-age & -length; 3) Increase women’s knowledge on breastfeeding practices; 4) Increase duration of exclusive breastfeeding and % of women exclusively breastfeeding at 6 months; 5) Increase women’s knowledge of complementary feeding; 6) Decrease the % of children under-2 years receiving snacks; 7) Increase the % of children consuming >4 food groups; 8) Decrease the number of children with diarrhea, acute respiratory illness or fever; 9) Decrease the prevalence of anemia in pregnant women & children under-2; 10) Be cost effective in reducing child undernutrition.

Unit of Intervention or Assignment:

The unit of randomization for the trial will be the sub-districts of two districts in East Java; Malang District and Sidoarjo District.

Number of Clusters in Sample:

There will be a total of 12 sub-districts, 6 from Malang and 6 from Sidoarjo.

Number of Individuals in Sample:

Cross-sectional Assessment: 2800 mother/infant pairs (234 mother/infant dyads per sub-district cluster); Cohort Evaluation: 966 mother/infant pairs (80-81/ sub-district cluster) (assuming 15% dropout)

Size of Treatment, Control, or Comparison Subsamples:

12 clusters with 6 intervention and 6 control. Cross sectional assessment: A representative sample of 1400 mother/infant pairs in each group. Cohort evaluation: 483 mother/infant pairs in each group.

Supplementary Files

Analysis Plan:

Pre-analysis plan .docx

Other Documents:

Data

Outcomes Data

Description:

The study will collect household and individual level data through a baseline and endline household survey for the cross-sectional assessments to assess the impact of the intervention on stunting prevalence. Several follow-up surveys for the cohort assessments of pregnant women that will be followed from late in the third trimester until their child is 18 months of age will collect individual level information on child growth indicators.

Data Already Collected?

No

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Treatment Assignment Data

Participation or Assignment Information:

Yes

Description:

Data Obtained by the Study Researchers?

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

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Registration Category

Registration Category:

Prospective, Category 1: Data for measuring impacts have not been collected

Completion

Completion Overview

Intervention Completion Date:

Data Collection Completion Date:

Unit of Analysis:

Clusters in Final Sample:

Total Observations in Final Sample:

Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:

Preliminary Report URL:

Summary of Findings:

Paper:

Paper Summary:

Paper Citation:

Data Availability

Data Availability (Primary Data):

Date of Data Availability:

Data URL or Contact:

Access procedure:

Other Materials

Survey:

Survey Instrument Links or Contact:

Program Files:

Program Files Links or Contact:

External Link:

External Link Description:

Description of Changes:

Study Stopped

Date:

Reason: