NCT03759821

Brief Summary

This study aims to evaluate the independent and combined effectiveness of engaging both mothers and fathers in bundled parenting and nutrition behavior change packages on early child nutrition and development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
960

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

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

First Submitted

Initial submission to the registry

October 27, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

October 27, 2018

Last Update Submit

April 28, 2021

Conditions

Child Nutrition and Early Child Development

Keywords

Infant and young child feedingNutritionStimulationParentingEarly childhood developmentSocial and behavior changeFather involvementMale engagementHousehold decision-makingCommunity health workersPeer groupsIntegrated interventions

Outcome Measures

Primary Outcomes (2)

  • Change in child dietary diversity (24 hrs)

    Child dietary diversity (24 hours) defined as the number of food groups out of eight food groups consumed in the previous day based on World Health Organization (WHO) guidelines and is assessed in children aged six months or older. A higher score reflects a higher likelihood of reaching a nutritionally adequate diet.

    12 months

  • Change in early child development

    Bayley Scales of Infant and Toddler Development, Third Edition is used to assess cognitive, language, and motor development. Each domain of development is reported separately. In each scale, raw scores are converted to composite scores ranging from 40-160. The average score is 100 and the standard deviation is 15. A higher score denotes higher performance.

    12 months

Secondary Outcomes (21)

  • Child dietary diversity (7 days)

    12 months

  • Child nutrition status

    12 months

  • Proportion of children who meet minimum meal frequency guidelines

    12 months

  • Parent-child interactions

    12 months

  • Caregiver early childhood development (ECD) knowledge

    12 months

  • +16 more secondary outcomes

Study Arms (5)

Nutrition, mothers

EXPERIMENTAL

Community health workers (CHWs) will facilitate peer group sessions with mothers of children aged 0-18 months at enrollment. The CHWs will deliver key messages and facilitate problem-solving and skill-building activities to promote nutrition-related behavior change. Group sessions will last between 1.5-2 hours and groups will meet biweekly for a period of 12 months. Due to the COVID pandemic, group sessions were paused for three months (March-June 2020). The intervention resumed in July 2020 with delivery via home visits rather than peer groups, and concluded in September 2020.

Behavioral: Nutrition, mothers

Nutrition, mothers and fathers

EXPERIMENTAL

Community health workers (CHWs) will facilitate peer group sessions with mothers and fathers of children aged 0-18 months at enrollment. The CHWs will deliver key messages and facilitate problem-solving and skill-building activities to promote nutrition-related behavior change. Group sessions will last between 1.5-2 hours and the groups will meet biweekly for a period of 12 months. Due to the COVID pandemic, group sessions were paused for three months (March-June 2020). The intervention resumed in July 2020 with delivery via home visits rather than peer groups, and concluded in September 2020.

Behavioral: Nutrition, mothers and fathers

Nutrition+parenting, mothers

EXPERIMENTAL

Community health workers (CHWs) will facilitate peer group sessions with mothers of children aged 0-18 months at enrollment. CHWs will deliver key messages and facilitate problem-solving and skill-building activities to promote nutrition and parenting-related behavior change. The group sessions will last between 1.5-2 hours and groups will meet biweekly for a period of 12 months. Due to the COVID pandemic, group sessions were paused for three months (March-June 2020). The intervention resumed in July 2020 with delivery via home visits rather than peer groups, and concluded in September 2020.

Behavioral: Nutrition+parenting, mothers

Nutrition+parenting, mothers and fathers

EXPERIMENTAL

Community health workers (CHWs) will facilitate peer group sessions with mothers and fathers of children aged 0-18 months at enrollment. CHWs will deliver key messages and facilitate problem-solving and skill-building activities to promote nutrition and parenting-related behavior change. The group sessions will last between 1.5-2 hours and groups will meet biweekly for a period of 12 months. Due to the COVID pandemic, group sessions were paused for three months (March-June 2020). The intervention resumed in July 2020 with delivery via home visits rather than peer groups, and concluded in September 2020.

Behavioral: Nutrition+parenting, mothers and fathers

Standard of care control

NO INTERVENTION

Local standard of care

Interventions

Nutrition, mothersBEHAVIORAL

Nutrition-related social and behavior change (SBC) messages and activities for mothers focused on infant and young child feeding (IYCF), dietary diversity, water, sanitation, and hygiene (WASH), food access (use of income and home-grown foods), psychosocial well-being, gender equity, intra-household resource allocation, partner communication and household decision-making

Nutrition, mothers
Nutrition, mothers and fathersBEHAVIORAL

Nutrition-related social and behavior change (SBC) messages and activities for mothers and fathers focused on infant and young child feeding (IYCF), dietary diversity, water, sanitation, and hygiene (WASH), food access (use of income and home-grown foods), psychosocial well-being, gender equity, intra-household resource allocation, partner communication and household decision-making

Nutrition, mothers and fathers
Nutrition+parenting, mothersBEHAVIORAL

Nutrition- and parenting-related social and behavior change (SBC) messages and activities for mothers focused on infant and young child feeding (IYCF), dietary diversity, responsive caregiving and child stimulation (play and communication), water, sanitation, and hygiene (WASH), food access (use of income and home-grown foods), psychosocial well-being, gender equity, intra-household resource allocation, partner communication and household decision-making

Nutrition+parenting, mothers
Nutrition+parenting, mothers and fathersBEHAVIORAL

Nutrition- and parenting-related social and behavior change (SBC) messages and activities for mothers and fathers focused on infant and young child feeding (IYCF), dietary diversity, responsive caregiving and child stimulation (play and communication), water, sanitation, and hygiene (WASH), food access (use of income and home-grown foods), psychosocial well-being, gender equity, intra-household resource allocation, partner communication and household decision-making

Nutrition+parenting, mothers and fathers

Eligibility Criteria

Age0 Months - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Household has a child aged 0-18 months at study enrollment
  • Child has a mother/female caregiver with a male partner
  • Mother, father, and child anticipate remaining in the study area for the duration of the study
  • The mother, and father where appropriate, is willing to participate in a peer group for the duration of the intervention, receiving full knowledge of the amount of time they are expected to contribute to this study.
  • Both mother and father provide informed consent.
  • Fathers have to be present in household with mother/child 10 months out of the year

You may not qualify if:

  • None (only those households not meeting all the above criteria will be excluded from the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Project Concern International

Musoma, Mara, Tanzania

Location

Related Publications (6)

  • Jeong J, Mapendo F, Hentschel E, McCann JK, Yousafzai AK. Validation of an observational tool for assessing mother-child and father-child interactions in Mara, Tanzania. Dev Psychol. 2025 Jan 9. doi: 10.1037/dev0001909. Online ahead of print.

    PMID: 39786795DERIVED

  • O'Malley SF, Ambikapathi R, Ghosh S, Galvin L, Jeong J, Mosha D, PrayGod G, Mapendo F, Shively G, Murray-Kolb LE, Gunaratna NS. Contribution of Food from Market Purchases and Home Production to Child Nutrient Intake: Evidence from the EFFECTS Study Baseline Data. J Nutr. 2024 Jun;154(6):1907-1916. doi: 10.1016/j.tjnut.2024.04.015. Epub 2024 Apr 11.

    PMID: 38608871DERIVED

  • EFFECTS Study Investigators. Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): study protocol for a five-arm, cluster-randomized trial. Trials. 2024 Mar 14;25(1):188. doi: 10.1186/s13063-022-07002-4.

    PMID: 38486278DERIVED

  • Jeong J, Ahun MN, Gunaratna NS, Ambikapathi R, Mapendo F, Galvin L, Kieffer MP, Mwanyika-Sando M, Mosha D, O'Malley SF, Verissimo CK, PrayGod G, Yousafzai AK. Effects of engaging fathers and bundling parenting and nutrition interventions on early child development and maternal and paternal parenting in Mara, Tanzania: a factorial cluster-randomized controlled trial. J Child Psychol Psychiatry. 2024 May;65(5):694-709. doi: 10.1111/jcpp.13897. Epub 2023 Oct 6.

    PMID: 37800367DERIVED

  • Galvin L, Verissimo CK, Ambikapathi R, Gunaratna NS, Rudnicka P, Sunseri A, Jeong J, O'Malley SF, Yousafzai AK, Sando MM, Mosha D, Kumalija E, Connolly H, PrayGod G, Endyke-Doran C, Kieffer MP. Effects of engaging fathers and bundling nutrition and parenting interventions on household gender equality and women's empowerment in rural Tanzania: Results from EFFECTS, a five-arm cluster-randomized controlled trial. Soc Sci Med. 2023 May;324:115869. doi: 10.1016/j.socscimed.2023.115869. Epub 2023 Mar 27.

    PMID: 37023660DERIVED

  • Ambikapathi R, Irema I, Lyatuu I, Caswell B, Mosha D, Nyamsangia S, Galvin L, Mangara A, Boncyk M, Froese SL, Verissimo CK, Itatiro J, Kariathi V, Kazonda P, Wandella M, Fawzi W, Killewo J, Mwanyika-Sando M, PrayGod G, Leyna G, Patil C, Gunaratna NS. Gender and Age Differences in Meal Structures, Food Away from Home, Chrono-Nutrition, and Nutrition Intakes among Adults and Children in Tanzania Using a Newly Developed Tablet-Based 24-Hour Recall Tool. Curr Dev Nutr. 2022 Feb 8;6(3):nzac015. doi: 10.1093/cdn/nzac015. eCollection 2022 Mar.

    PMID: 35317413DERIVED

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Mary Pat Kieffer, MSc.

    Project Concern International

    PRINCIPAL INVESTIGATOR

  • Nilupa Gunaratna, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Aisha Yousafzai, PhD

    Harvard H.T. Chan School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Eighty villages in the Mara region of Tanzania will be randomly selected and randomly allocated with equal probability and in equal numbers to one of the five EFFECTS study arms. In each participating village, one sub village will be randomly selected with equal probability, and a sampling frame of all households in that sub village will be created with the help of local leaders. Households will be selected from this sampling frame using simple random sampling. The selected households will be listed in random order and visited by study staff, who will assess whether a household meets all inclusion criteria and provides informed consent. Households will be visited until 12 households are enrolled in each village. If not enough eligible households are found, additional households will be selected using the same procedure from the nearest sub village in the same village.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Director for Health

Study Record Dates

First Submitted

October 27, 2018

First Posted

November 30, 2018

Study Start

October 30, 2018

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TA(1)