Engaging Fathers for Effective Child Nutrition and Development in Tanzania

NCT ID: NCT03759821

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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The overall aim of EFFECTS is to develop, implement, and evaluate nutrition and parenting interventions that will be delivered by community health workers in the Mara region of Tanzania. We will use a 2x2 factorial cluster randomized controlled study design, plus a local standard of care control group, to evaluate the effectiveness of EFFECTS on the primary outcomes of early child nutrition and development. In total, there will be five study arms: nutrition intervention with mothers, nutrition intervention with mothers and fathers, bundled nutrition and parenting intervention with mothers, bundled nutrition and parenting intervention with mothers and fathers, and a local standard of care control. We hypothesize that an intervention approach that engages fathers will benefit the primary outcomes; a bundled nutrition and parenting package will benefit the same primary outcomes; and that the combined intervention approach - that both engages fathers and bundles nutrition and parenting messages - will have additive benefits on the primary outcomes.

Conditions

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Child Nutrition and Early Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nutrition, mothers

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.

Group Type EXPERIMENTAL

Nutrition, mothers

Intervention Type BEHAVIORAL

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 and fathers

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.

Group Type EXPERIMENTAL

Nutrition, mothers and fathers

Intervention Type BEHAVIORAL

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+parenting, mothers

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.

Group Type EXPERIMENTAL

Nutrition+parenting, mothers

Intervention Type BEHAVIORAL

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 and fathers

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.

Group Type EXPERIMENTAL

Nutrition+parenting, mothers and fathers

Intervention Type BEHAVIORAL

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

Standard of care control

Local standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutrition, mothers

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

Intervention Type BEHAVIORAL

Nutrition, mothers and fathers

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

Intervention Type BEHAVIORAL

Nutrition+parenting, mothers

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

Intervention Type BEHAVIORAL

Nutrition+parenting, mothers and fathers

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* None (only those households not meeting all the above criteria will be excluded from the study)
Minimum Eligible Age

0 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue University

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Africa Academy for Public Health

OTHER

Sponsor Role collaborator

The Eleanor Crook Foundation

UNKNOWN

Sponsor Role collaborator

Conrad N. Hilton Foundation

OTHER

Sponsor Role collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role collaborator

Project Concern International

OTHER

Sponsor Role lead

Responsible Party

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Mary Pat Kieffer

Senior Director for Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Pat Kieffer, MSc.

Role: PRINCIPAL_INVESTIGATOR

Project Concern International

Nilupa Gunaratna, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Aisha Yousafzai, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard H.T. Chan School of Public Health

Locations

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Project Concern International

Musoma, Mara, Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED
PMID: 39786795 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38608871 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38486278 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37800367 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37023660 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35317413 (View on PubMed)

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id

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