NCT06473025

Brief Summary

The goal of this randomized controlled trial is to examine the role of parental misperceptions and information gaps in contributing to poor child dietary practices and high child undernutrition rates in India. The main research questions it seeks to answer are:

  1. 1.Do mothers systematically overestimate the nutritional status (height- and weight-for-age percentiles) of their children, relative to global World Health Organization (WHO) standards and other children in their region?,
  2. 2.Do mothers underestimate the returns to child nutrition on long-term health, education, and labor market outcomes?,
  3. 3.What mechanisms could explain the formation of such misperceptions? Are mothers with higher exposure to undernourished children more likely to overestimate their children's nutritional status?, and
  4. 4.Would updating mothers' beliefs about a) their children's true height-for-age and weight-for-age percentiles, and/or b) the returns to child nutrition, improve child feeding practices, utilization of government nutrition services, and child growth outcomes?

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,542

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

June 13, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 18, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

June 13, 2024

Last Update Submit

October 15, 2024

Conditions

Keywords

child malnutritionstuntingindiachild feedingbehavioralmisperceptions

Outcome Measures

Primary Outcomes (11)

  • Average willingness-to-pay for protein-rich food bundle

    All mothers who participate in the survey will be entered into a lottery to win a bundle of protein-rich food items for their child or, alternatively, a randomly chosen cash prize (amount may range from Rs. 100 to Rs. 2000). 25 lottery "winners" will be chosen randomly at the end of the baseline survey. Mothers will be asked to state their preferences between the food bundle and several potential cash prize amounts, using a multiple-price-list elicitation method. One cash prize amount will be randomly chosen for each mother, and their choice for that amount will be implemented in case they win the lottery. WTP will be measured by the mid-point of the interval of two cash amounts at which a mother switches from preferring to receive cash to preferring to receive food. Possible values range from 0 to 2000. Average willingness-to-pay will be compared between mothers in the treatment groups and the control group.

    Baseline

  • Difference between true and perceived height-for-age percentile relative to WHO standards

    The difference between the child's true height-for-age percentile relative to the WHO reference population and the mother's perceived percentile rank. Values may range from 0 to 100.

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Difference between true and perceived weight-for-age percentile relative to WHO standards

    The difference between the child's true weight-for-age percentile relative to the WHO reference population and the mother's perceived percentile rank. Values may range from 0 to 100.

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Knowledge score on returns to child nutrition (Binary)

    Binary variable coded "1" if at least half the prompts (3 out of 6) about the returns to child nutrition are answered correctly, and "0" otherwise. This is a binary indicator constructed based on the knowledge score scale that may range from 0 to 6, with higher scores representing better knowledge.

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Minimum frequency of meals

    Binary variable coded "1" if the child consumed the minimum recommended number of meals in the last 24 hours, based on their age, and "0" otherwise

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Minimum dietary diversity

    Binary variable coded "1" if the child consumed food from at least 5 of the 8 specified food groups in the last 24 hours, and "0" otherwise. This is a binary indicator constructed based on the World Health Organization "Minimum Dietary Diversity - Infant and Young Child Feeding" (MDD-IYCF) scale. Scores may range from 0 to 8, with higher scores representing better outcomes.

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Height-for-age z-score

    Height-for-age z-score at the time of the endline survey

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Weight-for-age z-score

    Weight-for-age z-score at the time of the endline survey

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Weight-for-height z-score

    Weight-for-height z-score at the time of the endline survey

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Consumption of Balamrutham

    Binary variable coded "1" if the child consumed Balamrutham (government-provided therapeutic food) in the last 24 hours, and "0" otherwise

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • CREDI child cognition scale z-score

    The Caregiver-Reported Early Development Instruments (CREDI) Short Form is a validated set of 20 population-level measures of early childhood development (ECD) for children from birth to age three (0-36 months). The responses on this 20-point scale (based on age) will be converted to a norm-referenced standardized Z-score for overall development. The z-scores may range from -6 to +6, with larger scores representing better outcomes.

    During endline survey, an average of 4 months (or 17 weeks) from baseline

Secondary Outcomes (7)

  • Change from baseline in height-for-age z-score

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Change from baseline in weight-for-age z-score

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Change from baseline in weight-for-height z-score

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Change from baseline in height

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Change from baseline in weight

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • +2 more secondary outcomes

Other Outcomes (3)

  • Knowledge score on returns to child nutrition (Continuous)

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Diet adequacy

    During endline survey, an average of 4 months (or 17 weeks) from baseline

  • Grams of protein consumed in last 24 hours

    During endline survey, an average of 4 months (or 17 weeks) from baseline

Study Arms (3)

Treatment Arm 1: Relative Nutritional Status

EXPERIMENTAL

Provide information on the true height-for-age and weight-for-age percentiles of the child relative to a reference group of healthy children based on WHO standards

Behavioral: Information on Relative Nutritional Status

Treatment Arm 2: Relative Nutritional Status and Returns

EXPERIMENTAL

Provide information on the true height-for-age and weight-for-age percentiles of the child relative to a reference group of healthy children based on WHO standards AND provide information on the impacts of child undernutrition on health (risk of chronic and infectious diseases, mortality), education (high school test scores, years of education), and labor market (earnings) outcomes, synthesized from existing literature

Behavioral: Information on Relative Nutritional StatusBehavioral: Information on Returns to Child Nutrition

Control Arm

NO INTERVENTION

Status-quo, no intervention

Interventions

The intervention involves providing information on the height-for-age and weight-for-age percentiles of children relative to a reference group of healthy children based on WHO standards

Treatment Arm 1: Relative Nutritional StatusTreatment Arm 2: Relative Nutritional Status and Returns

The intervention involves providing information on the effects of child undernutrition on long-term health, education, and labor market outcomes.

Treatment Arm 2: Relative Nutritional Status and Returns

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Biological mothers of sampled children aged 7-24 months

You may not qualify if:

  • Any medical/health condition that precludes individuals from understanding the study procedures or communicating with study personnel (eg. deafness, inability to speak, mental health conditions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Women Development and Child Welfare

Hyderabad, Telangana, 500038, India

Location

MeSH Terms

Conditions

Child Nutrition DisordersGrowth DisordersBehavior

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sneha Nimmagadda, M.Sc.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: * Treatment arm 1: Update mothers' beliefs on the height-for-age and weight-for-age percentiles of their child relative to a reference group of healthy children based on WHO standards * Treatment arm 2: Treatment 1 + information on the impacts of child undernutrition on health (risk of chronic and infectious diseases, mortality), education (high school test scores, years of education), and labor market (earnings) outcomes, synthesized from existing literature * Control arm: Status-quo, no intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 25, 2024

Study Start

September 18, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

October 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

De-identified data will be made publicly available through an open-access repository (eg. ICPSR) after publication of the study findings.

Time Frame
Within 6 months after publication
Access Criteria
No access criteria. De-identified data will be made publicly available through an open-access repository (eg. ICPSR).

Locations