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CompletedNCT03759821EFFECTSUpdated May 3, 2021

Engaging Fathers for Effective Child Nutrition and Development in Tanzania

An interventional study of Nutrition, mothers and Nutrition, mothers and fathers in Child Nutrition and Early Child Development, sponsored by Project Concern International. Completed at 1 site in Tanzania. Open to participants aged 0 Months to 18 Months. Per ClinicalTrials.gov, last updated 2021-05-03.

Sponsored by Project Concern International · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
960
Allocation
Randomized
Ages
0 Months to 18 Months
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Child Nutrition and Early Child Development

Keywords

  • Infant and young child feeding
  • Nutrition
  • Stimulation
  • Parenting
  • Early childhood development
  • Social and behavior change
  • Father involvement
  • Male engagement
  • Household decision-making
  • Community health workers
  • Peer groups
  • Integrated interventions
03

In context

Lead sponsor

This is the only study on the registry with Project Concern International as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • None (only those households not meeting all the above criteria will be excluded from the study)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
960 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Nutrition, mothers

  • Experimental
    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.

    Behavioral: Nutrition, mothers and fathers

  • Experimental
    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.

    Behavioral: Nutrition+parenting, mothers

  • Experimental
    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.

    Behavioral: Nutrition+parenting, mothers and fathers

  • No intervention
    Standard of care control

    Local standard of care

Interventions

  • BehavioralNutrition, 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

  • BehavioralNutrition, 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

  • BehavioralNutrition+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

  • BehavioralNutrition+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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

Secondary outcomes

  1. Child dietary diversity (7 days)

    Child dietary diversity (7 days) defined as number of food groups out of a total of eight food groups consumed in the previous seven days based on 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.

    Time frame: 12 months

  2. Child nutrition status

    Calculated as height-for-age Z-scores (HAZ) and weight-for-height Z-scores (WHZ), based on WHO Multicentre Child Growth Standards.

    Time frame: 12 months

  3. Proportion of children who meet minimum meal frequency guidelines

    Using a caregiver self-reported questionnaire adapted from WHO-UNICEF, proportion of children aged six months or older (breastfeeding and non-breastfeeding) who meet minimum meal frequency guidelines during the previous 24 hours.

    Time frame: 12 months

  4. Parent-child interactions

    Interactions of the child with each parent using the Observation of Mother-Child Interactions tool. Total scores are summed. A higher score represents better parent-child interactions.

    Time frame: 12 months

  5. Caregiver early childhood development (ECD) knowledge

    Caregiver (mother and father) knowledge of early childhood development (ECD) assessed using a caregiver self-report questionnaire of the perceived expected ages at which children can attain developmental milestones. Responses within a theoretically defined age range are scored as correct, and an overall knowledge of ECD score is created by summing the total number of correct items. Higher scores represent improved knowledge of ECD.

    Time frame: 12 months

  6. Caregiver infant and young child feeding (IYCF) knowledge

    Caregiver (mother and father) knowledge on two topics: 1) Breastfeeding knowledge and support score; 2) Complementary feeding knowledge score (food consistency, nutritious porridge, growth); These are based on questionnaire adapted from WHO-UNICEF. Total scores (# of correct responses) are summed; a higher score represents higher level of knowledge related to recommended IYCF practices.

    Time frame: 12 months

  7. Change from baseline in household food allocation of animal source foods

    Consumption of animal source foods (ASF: eggs, meat, and fish but excluding dairy) yesterday by child given father, mother, or child consumed ASF \[household ASF consumption\] yesterday; Consumption of ASF yesterday by mother given household ASF consumption yesterday; Consumption of ASF yesterday by father given household ASF consumption yesterday

    Time frame: 12 months

  8. Responsive feeding practices

    Responsive feeding was measured among mothers using a maternal-reported scale. Each item is scored on 4-point Likert scale: 0 = never, 1 = sometimes, 2 = often, and 3 = always. Negatively worded items were reverse scored. We created an overall responsive feeding score based on the average of 8 items, whereby higher scores indicated more responsive feeding behaviors.

    Time frame: 12 months

  9. Caregiver stimulation practices

    Caregiver (mother and father) stimulation practices assessed using a caregiver self-report questionnaire of the frequency of engagement in stimulation activities (e.g., naming things, playing) with the child in the past week, adapted from the Family Care Indicators. Each item was scored on a 4-point frequency scale (0=never, 1=once or twice a week, 2=multiple times a week, and 3=every day or nearly every day) and summed for a total score. Higher scores represent more frequent engagement in stimulation.

    Time frame: 12 months

  10. Co-parenting

    For the brief version of the Co-parenting Relationship Scale (CRS), each item is scored on a 4-point scale, ranging from 0=not true, 1=a little bit true, 2=mostly true, 3=very true. The items are averaged to generate a total score, which similarly ranges from 0 to 3. Higher values of the total average score indicate more positive co-parenting.

    Time frame: 12 months

  11. Couples' communication (frequency, quality) and decision-making

    Couples' communication and decision-making with respect to household matters (e.g., income, food allocation) using a self-report questionnaire adapted from Promundo and asked to both mothers and fathers. Two sub-scales will be reported: (1) frequency of communication, which is the average across 8 Likert-scored items (3=often, 2=sometimes, 1=rarely, and 0=never); (2) women's decision-making power, which is the total number of decisions over which the woman had the final say independently or jointly with her partner (8 total items). Higher scores will represent more frequent couples' communication and greater women's decision-making power.

    Time frame: 12 months

  12. Gender equitable attitudes

    Attitudes toward gender norms and roles assessed on both women and men. For each of the 12 items on the scale, women and men will report their level of agreement scored on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree). The items are summarized to generate a total score ranging from 12 to 60 or a standardized z-score. Higher values indicate more gender equitable attitudes toward gender norms and women's and men's social roles and relations within a household.

    Time frame: 12 months

  13. Time use patterns

    Time use patterns using 7 day recall, particularly chores and childcare activities, using adapted version of International Food Policy Research Institute's Women's Empowerment in Agriculture (WEIA) tool, assessed on both mothers and fathers. Two main indicators of time use will be reported - time spent on work activities (which can be further grouped into domestic chores and income-generating activities) and non-work activities (leisure and rest) - which each refer to the total number of hours spent for that category of activities. Smaller differences in time spent between men and women indicate greater gender equity at household level.

    Time frame: 12 months

  14. Proportion of households that purify drinking water

    Using a caregiver self-report questionnaire adapted from WHO-UNICEF, 2 items will be administered to caregivers to calculate proportion of households that purify drinking water.

    Time frame: 12 months

  15. Proportion of households with observed animal feces in house or compound

    Using an observational checklist adapted from WHO-UNICEF, 1 item will assess presence of animal feces in house or compound (yes/no).

    Time frame: 12 months

  16. Change in frequency of caregiver handwashing with cleansing agent at critical times during the past 24 hours

    Using a caregiver self-report questionnaire adapted from WHO-UNICEF, 3 items will be administered to measure change in frequency of handwashing with cleansing agent at critical times during the past 24 hours.

    Time frame: 12 months

  17. Change in frequency of child handwashing with cleansing agent at critical times during the past 24 hours

    Using a caregiver self-report questionnaire adapted from WHO-UNICEF, 3 items will be administered to measure change in frequency of child handwashing with cleansing agent at critical times during the past 24 hours.

    Time frame: 12 months

  18. Caregiver water, sanitation, and hygiene (WASH) knowledge

    Caregiver (mother and father) knowledge of recommended water, sanitation, and hygiene (WASH) practices (making food safe, avoiding sickness, washing hands). These are based on questionnaire adapted from WHO-UNICEF. Total scores (# of correct responses) are summed; a higher score represents higher level of knowledge related to recommended WASH practices.

    Time frame: 12 months

  19. Maternal and paternal depressive symptoms

    Maternal and paternal depressive symptoms will be measured using the Self-Reporting Questionnaire (SRQ-20, excluding the item on suicidal ideation). The SRQ-20 comprises 20 yes/no items to assess the presence of depression and anxiety-related symptoms in the past 30 days. The 19 items used in this study will be summed to create a total score, ranging from 0 to 20.

    Time frame: 12 months

  20. Intimate partner violence (IPV)

    Mothers' experience of intimate partner violence will be measured based on self-reported experiences of physical, emotional, and/or sexual violence by their male partner in the past 3 months. These questions come from IPV questionnaire in the domestic violence module of the Tanzania Demographic and Health Surveys. Maternal victimization of IPV will be analyzed according to four classifications: (1) any type of violence; (2) any physical violence; (3) any emotional violence; and (4) any sexual violence.

    Time frame: 12 months

  21. Parenting stress

    The Parental Distress subscale of the Parenting Stress Index questionnaire was used with both mothers and fathers. Each item is scored on a 4-point Likert scale. Applicable items will be reverse-coded, such that the highest response option=4 is in the direction of more parenting stress and response option=1 is reflective of minimal/no parenting stress. Total scores will be calculated for the Parental Distress subscale. Higher scores indicate greater parenting stress.

    Time frame: 12 months

07

Study locations

1 site
  • Project Concern International
    Musoma, Mara, Tanzania
08

References and documents

Publications

  • 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. PubMed 35317413 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03759821
Lead sponsor
Project Concern International
Collaborators
Purdue University, Harvard School of Public Health (HSPH), Africa Academy for Public Health, The Eleanor Crook Foundation, Conrad N. Hilton Foundation, National Institute for Medical Research, Tanzania
Responsible party
Mary Pat Kieffer (Senior Director for Health, Project Concern International) — Principal investigator
First posted
Nov 30, 2018
Start date
Oct 30, 2018
Primary completion
Feb 28, 2021
Completion
Feb 28, 2021
Last update
May 3, 2021

Study contacts

Mary Pat Kieffer, MSc.
principal investigator · Project Concern International
Nilupa Gunaratna, PhD
principal investigator · Purdue University
Aisha Yousafzai, PhD
principal investigator · Harvard H.T. Chan School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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