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Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS)

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ClinicalTrials.gov Identifier: NCT03759821
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborators:
Purdue University
Harvard School of Public Health
Africa Academy for Public Health
The Eleanor Crook Foundation
Conrad N. Hilton Foundation
Information provided by (Responsible Party):
Mary Pat Kieffer, Project Concern International

Brief Summary:
This study aims to evaluate the independent and combined effectiveness of engaging both mothers and fathers in peer group sessions and bundling parenting and nutrition behavior change packages on early child nutrition and development.

Condition or disease Intervention/treatment Phase
Child Nutrition and Early Child Development Behavioral: Nutrition, mothers Behavioral: Nutrition, mothers and fathers Behavioral: Nutrition+parenting, mothers Behavioral: Nutrition+parenting, mothers and fathers Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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 5 EFFECTS study arms. In each participating village, a sampling frame of all households in that 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): A Community-Based Bundled Nutrition and Parenting Intervention
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutrition, mothers
Community health workers (CHWs) will facilitate peer group sessions with mothers of children aged 0-18 months. 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. Between 12 and 18 months, there will be booster sessions to reinforce key messages.
Behavioral: 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

Experimental: Nutrition, mothers and fathers
Community health workers (CHWs) will facilitate peer group sessions with mothers and fathers of children aged 0-18 months. 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. Between 12 and 18 months, there will be booster sessions to reinforce key messages.
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

Experimental: Nutrition+parenting, mothers
Community health workers (CHWs) will facilitate peer group sessions with mothers of children aged 0-18 months. 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.
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

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. 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.
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

No Intervention: Standard of care control
Local standard of care



Primary Outcome Measures :
  1. Child dietary diversity (24 hrs) [ Time Frame: 24 months ]
    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. A higher score reflects a higher likelihood of reaching a nutritionally adequate diet.

  2. Early child development [ Time Frame: 12 months ]
    Bayley Scales of Infant and Toddler Development, Third Edition is used to assess cognitive, language, motor and socio-emotional 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.


Secondary Outcome Measures :
  1. Child dietary diversity (7 days) [ Time Frame: 24 months ]
    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. A higher score reflects a higher likelihood of reaching a nutritionally adequate diet.

  2. Child height [ Time Frame: 24 months ]
    Calculated as height-for-age Z-scores (HAZ), based on WHO Multicentre Child Growth Standards.

  3. Child weight [ Time Frame: 24 months ]
    Calculated as weight-for-height Z-scores (WHZ), based on WHO Multicentre Child Growth Standards.

  4. Proportion of children who meet minimum meal frequency guidelines [ Time Frame: 24 months ]
    Using a caregiver self-reported questionnaire adapted from WHO-UNICEF, proportion of children (breastfeeding and non-breastfeeding) who meet minimum meal frequency guidelines during the previous 24 hours.

  5. Mother-child interactions [ Time Frame: 12 months ]
    Mother and child interactions using the Observation of Mother-Child Interactions tool. Total scores are summed. A higher score represents better mother-child interactions.

  6. Caregiver early childhood development (ECD) knowledge and practices [ Time Frame: 12 months ]
    Caregiver (mother and father) early childhood development knowledge and practices assessed using a caregiver self-report questionnaire adapted from the Family Care Indicators. Total scores are summed. A higher score represents better caregiver knowledge of and practices related to early childhood development.

  7. Co-parenting [ Time Frame: 12 months ]
    For the brief version of the Coparenting Relationship Scale (CRS), each item is scored on a 4-point scale, ranging from 0=not true, 1=a little bit true of us, 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.

  8. Couples' communication (frequency, quality) and decision-making [ Time Frame: 24 months ]
    Couples' communication and decision-making related to income, food procurement, and food consumption using a self-report questionnaire adapted from Promundo and assessed on both female and male caregivers. Three sub-scales that will be developed. Sub-scales will assess (1) frequency of communication (8 items): 4=often, 3=sometimes, 2=rarely, and 0=never; (2) quality of communication (8 items) "when discussing [topic] with partner, do you feel your opinions are taken seriously:" 4=often, 3=sometimes, 2=rarely, and 0=never; (3) control over final decisions (8 items): 4=mother, 3=joint mother and father, 2=father, 1=someone else. Scores will be summarized to generate total couples communication and decision making score and sub-scores. Higher scores are indicative of better couples' communication practices and women's decision-making power/autonomy.

  9. Change from baseline in household food allocation of animal source foods [ Time Frame: 12, 24 months ]
    Using a caregiver self-report questionnaire adapted from WHO-UNICEF, 3 items will measure food allocation of animal source foods in the household. Change from baseline will be assessed at 12 and 24 months. An increase in proportion of children and/or mothers receiving animal source food before father or a decrease in proportion of children and/or mothers receiving animal source food last are indicative of more equitable household food allocation practices.

  10. Time use patterns [ Time Frame: 12, 24 months ]
    Change from baseline at 12 and 24 months in 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. In particular, changes in women's time and frequency spent on child care, house work, and farm activities compared to men's will be used to measure change in equity at household level; less disparity between couples in frequency and time spent on child care, house work, and farm activities is indicative of greater gender equity in the household.

  11. Proportion of households that purify drinking water [ Time Frame: 24 months ]
    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.

  12. Proportion of households with observed animal feces in house or compound [ Time Frame: 24 months ]
    Using an observational checklist adapted from WHO-UNICEF, 1 item will assess presence of animal feces in house or compound (yes/no).

  13. Change in frequency of caregiver handwashing with cleansing agent at critical times during the past 24 hours [ Time Frame: 12, 24 months ]
    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. Change from baseline will be assessed at 12 and 24 months.

  14. Change in frequency of child handwashing with cleansing agent at critical times during the past 24 hours [ Time Frame: 12, 24 months ]
    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. Change from baseline will be assessed at 12 and 24 months.

  15. Caregiver infant and young child feeding (IYCF) knowledge [ Time Frame: 24 months ]
    Caregiver (mother and father) knowledge of recommended infant and young child feeding practices using a caregiver self-report 9-item questionnaire adapted from WHO-UNICEF. Total scores (# of correct responses) are summed; a higher score represents a higher level of knowledge regarding recommended IYCF practices.

  16. Caregiver water, sanitation, and hygiene (WASH) knowledge [ Time Frame: 24 months ]
    Caregiver (mother and father) knowledge of recommended water, sanitation, and hygiene (WASH) practices assessed using the a caregiver 3-item open-ended multiple response self-report 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, ranging from 0-30.

  17. Gender attitudes [ Time Frame: 12, 24 months ]
    Change from baseline at 12 and 24 months in 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 represent a better score and indicate more gender equitable attitudes toward gender norms and women's and men's social roles and relations within a household.

  18. Maternal and paternal depressive symptoms [ Time Frame: 24 months ]
    Maternal and paternal depressive symptoms will be measured using the Self-Reporting Questionnaire (SRQ-20). The SRQ-20 comprises 20 yes/no items to assess the presence of depression and anxiety-related symptoms in the past 30 days. The 20 items will be summed to create a total score, ranging from 0 to 20.

  19. Intimate partner violence [ Time Frame: 24 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759821


Contacts
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Contact: Mary Pat Kieffer, MSc 202-223-0088 ext 625 mpkieffer@pciglobal.org
Contact: Lauren Galvin, MPH +250 786 038 539 lgalvin@pciglobal.org

Locations
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Tanzania
Project Concern International Recruiting
Musoma, Mara, Tanzania
Contact: Mary Pat Kieffer, MSc    202-223-0088 ext 625    mpkieffer@pciglobal.org   
Contact: Lauren Galvin, MPH    +250 786 038 539    lgalvin@pciglobal.org   
Sponsors and Collaborators
Project Concern International
Purdue University
Harvard School of Public Health
Africa Academy for Public Health
The Eleanor Crook Foundation
Conrad N. Hilton Foundation
Investigators
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Principal Investigator: Mary Pat Kieffer, MSc. Project Concern International
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Responsible Party: Mary Pat Kieffer, Senior Director for Health, Project Concern International
ClinicalTrials.gov Identifier: NCT03759821    
Other Study ID Numbers: 01
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Pat Kieffer, Project Concern International:
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