NCT07004608

Brief Summary

Aalana Palan designed, implemented and evaluated an integrated early child development \& nutrition intervention promoting nurturing care in the first 1000 days of life in Telangana, India. It was developed in collaboration with UNICEF and the Department of Women Development and Child Welfare Telangana. Aalana Palana in Telugu - implies a caring and nurturing environment provided by caregivers to their children. It promotes an inclusive environment for adequate nutrition, responsive and sensitive caregiving including opportunities for learning. Aalana Palana draws from the Nurturing Care Framework that provides guidance on giving children the best start in their lives. Aalana Palana was developed through extensive community engagement, using culturally relevant and locally adaptable video content. This participatory approach ensured its acceptability and contributed to its success in addressing critical gaps in child growth and development. It was delivered entirely within the existing Integrated Child Development Scheme which ensured its sustainability. The innovative use of facilitated video-viewing allowed for standardized delivery of evidence-based practices, around optimal nutrition and parenting during the first 1000 days, reducing the burden on frontline workers while improving caregiver engagement and comprehension. This intervention was used by Anganwadi workers to conduct group and individual counselling sessions with caregivers in their communities. Aalana Palana implemented a transition from traditional paper-based counselling sessions to a video-based, discussion and demonstration led counselling model. Age specific videos promoted responsive and sensitive parenting, early learning opportunities for children \& include desired nutritional practices for young children \& pregnant women. The content not only describes 'WHAT' behaviours caregiver should adopt, 'HOW' they could include these behaviours in their routines but also 'WHY' a particular behaviour is important for their child's development. A key strength of this study is its policy relevance. Aalana Palana has been incorporated into the ICDS guidelines for Supplementary Nutrition Program in Telangana, providing a blueprint for scaling similar programs across the country and in other LMICs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,824

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

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, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

May 14, 2025

Last Update Submit

June 4, 2025

Conditions

Keywords

Early Child DevelopmentSystem integrationICDSAnganwadi WorkerFacilitated Video ViewingParenting interventionChild nutritionFirst 1000 days of life

Outcome Measures

Primary Outcomes (1)

  • Caregiver Reported Early Development Instruments (CREDI)

    A caregiver-reported population-level measure of early childhood development for children aged 0-36 months, was used to assess child development through easily observable milestones and behaviours, focusing on developmental progress. The tool consists of four domains - motor, language, cognitive and socio-emotional. We used the long-form which comprises 108 items. With permission from the publishers, the Sangath team translated the CREDI in Telugu for use in ASPIRE. The Telugu version of the form can be found on their website.

    From July 2023 to January 2024

Secondary Outcomes (2)

  • The Family Care Indicators (FCI) questionnaire

    From July 2023 to January 2024

  • The Infant and Young Child Feeding (IYCF) framework

    From July 2023 to January 2024

Interventions

Aalana PalanaBEHAVIORAL

Alan Palana is a facilitated video viewing intervention which promotes responsive and sensitive parenting, early learning opportunities and desired nutritional practices for young children and pregnant women. The content not only describes 'WHAT' behaviours caregiver should adopt, 'HOW' they could include these behaviours in their routines but also 'WHY' a particular behaviour is important for their child's development.

Eligibility Criteria

Age0 Years - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will comprise all primary caregivers of children under 3 years of age residing in the catchment areas of 30 Anganwadi Centres (AWCs) where the Aalana Palana intervention will be implemented. A household-level mapping exercise will be conducted within the selected AWC catchment areas to identify eligible caregivers. All eligible participants will be approached for consent to participate in the study. Those who provide informed consent will be enrolled and subsequently classified into two groups based on their self-reported exposure to the intervention: Exposed group: Participants who report having seen at least one Aalana Palana video in the three months preceding data collection. Unexposed group: Participants who report not having seen any Aalana Palana videos in the same period. A three-month reference period will be used to minimise recall bias regarding exposure to the video-based intervention.

You may qualify if:

  • Primary caregiver of a child aged between 0-3 years
  • Resident of the intervention area and likely to remain for the study duration
  • Able and willing to provide informed consent

You may not qualify if:

  • Caregivers of children with severe medical conditions requiring intensive hospital-based care
  • Families already enrolled in another similar ECD intervention trial
  • Caregivers who do not speak the local language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sangath

Goa, 403501, India

Location

Related Publications (12)

  • Nelson AK, Griest CJ, Munoz LM, Rumaldo N, Miller AC, Soplapuco GM, Lecca L, Shin SS, Acuna LR, Valdivia YV, Ramos AR, Ahumada DG, Ramos BRH, Mejia SA, Serrano EO, Castro WH, Oliva VE, Heyman AS, Hartwell LP, Blackwell RL, Diaz DF, Vibbert MM. Proof of concept of the Universal Baby video innovation for early child development in Lima, Peru. J Pediatr Psychol. 2025 Jan 1;50(1):51-62. doi: 10.1093/jpepsy/jsae035.

    PMID: 38872286BACKGROUND
  • Antelman G, Ferla J, Gill MM, Hoffman HJ, Komba T, Abubakar A, Remes P, Jahanpour O, Mariki M, Mang'enya MA, van de Ven R. Effectiveness of an integrated multilevel early child development intervention on caregiver knowledge and behavior: a quasi-experimental evaluation of the Malezi program in Tanzania. BMC Public Health. 2023 Jan 4;23(1):19. doi: 10.1186/s12889-022-14956-2.

    PMID: 36600280BACKGROUND
  • Feil EG, Baggett K, Davis B, Landry S, Sheeber L, Leve C, Johnson U. Randomized control trial of an internet-based parenting intervention for mothers of infants. Early Child Res Q. 2020 1st Quarter;50(Pt 1):36-44. doi: 10.1016/j.ecresq.2018.11.003. Epub 2018 Dec 8.

    PMID: 32863565BACKGROUND
  • Webster-Stratton C, Kolpacoff M, Hollinsworth T. Self-administered videotape therapy for families with conduct-problem children: comparison with two cost-effective treatments and a control group. J Consult Clin Psychol. 1988 Aug;56(4):558-66. doi: 10.1037//0022-006x.56.4.558. No abstract available.

    PMID: 3143750BACKGROUND
  • Feroz A, Jabeen R, Saleem S. Using mobile phones to improve community health workers performance in low-and-middle-income countries. BMC Public Health. 2020 Jan 13;20(1):49. doi: 10.1186/s12889-020-8173-3.

    PMID: 31931773BACKGROUND
  • Winters N, Langer L, Geniets A. Scoping review assessing the evidence used to support the adoption of mobile health (mHealth) technologies for the education and training of community health workers (CHWs) in low-income and middle-income countries. BMJ Open. 2018 Jul 30;8(7):e019827. doi: 10.1136/bmjopen-2017-019827.

    PMID: 30061430BACKGROUND
  • Scott K, Beckham SW, Gross M, Pariyo G, Rao KD, Cometto G, Perry HB. What do we know about community-based health worker programs? A systematic review of existing reviews on community health workers. Hum Resour Health. 2018 Aug 16;16(1):39. doi: 10.1186/s12960-018-0304-x.

    PMID: 30115074BACKGROUND
  • Jaskiewicz W, Tulenko K. Increasing community health worker productivity and effectiveness: a review of the influence of the work environment. Hum Resour Health. 2012 Sep 27;10:38. doi: 10.1186/1478-4491-10-38.

    PMID: 23017131BACKGROUND
  • Grantham-McGregor SM, Walker SP. Early Childhood Interventions: Issues to Consider in Getting to Scale. Pediatrics. 2023 May 1;151(Suppl 2):e2023060221P. doi: 10.1542/peds.2023-060221P. No abstract available.

    PMID: 37125888BACKGROUND
  • Jeong J, Franchett EE, Ramos de Oliveira CV, Rehmani K, Yousafzai AK. Parenting interventions to promote early child development in the first three years of life: A global systematic review and meta-analysis. PLoS Med. 2021 May 10;18(5):e1003602. doi: 10.1371/journal.pmed.1003602. eCollection 2021 May.

    PMID: 33970913BACKGROUND
  • Dulal S, Prost A, Karki S, Saville N, Merom D. Characteristics and effects of integrated nutrition and stimulation interventions to improve the nutritional status and development of children under 5 years of age: a systematic review and meta-analysis. BMJ Glob Health. 2021 Jul;6(7):e003872. doi: 10.1136/bmjgh-2020-003872.

    PMID: 34321232BACKGROUND
  • Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.

    PMID: 27717614BACKGROUND

Study Officials

  • Gauri Divan

    Sangath

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 4, 2025

Study Start

July 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The complete raw dataset, accompanied by a detailed data dictionary explaining each variable and the study's analysis plan, will be made available to interested researchers. Data access will begin one year after publication and remain open indefinitely. Individuals or institutions wishing to use the data may submit a request by contacting the corresponding author via email. Access will be provided upon approval and, if required, the signing of a data access agreement with the senior investigators of the program. This approach aims to promote transparency, encourage secondary analyses, and support collaborative research efforts in the field.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Beginning 1 year after publication with no end date

Locations