Child Nutrition and Early Child DevelopmentEFFECTSNCT03759821
Engaging Fathers for Effective Child Nutrition and Development in Tanzania
A study testing Nutrition, mothers, Nutrition, mothers and fathers and Nutrition+parenting, mothers in people with Child Nutrition and Early Child Development, run by Project Concern International at 1 site in Tanzania.
Trial 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 more about this study
- Who is it for?
- Ages 0 to 18 months
- Conditions the study is for
- Child Nutrition and Early Child Development
- What is being tested?
- Nutrition, mothers, Nutrition, mothers and fathers and Nutrition+parenting, mothers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteTanzania
- Study dates
- 30 Oct 2018to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- None (only those households not meeting all the above criteria will be excluded from the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): A Community-Based Bundled Nutrition and Parenting Intervention
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.
- Being tested
- Nutrition, mothers, Nutrition, mothers and fathers, Nutrition+parenting, mothers, Nutrition+parenting, mothers and fathers
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition, mothersBehavioural
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 fathersBehavioural
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, mothersBehavioural
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 fathersBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Nutrition+parenting, mothers and fathers |
| Standard of care control | No intervention | Local standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (21)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start30 Oct 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Child Nutrition and Early Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Project Concern International
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Mary Pat Kieffer, Project Concern International
- Investigators
- Mary Pat Kieffer, MSc., Principal investigator, Project Concern InternationalNilupa Gunaratna, PhD, Principal investigator, Purdue UniversityAisha Yousafzai, PhD, Principal investigator, Harvard H.T. Chan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759821
- Sponsor's protocol ID
- 01
- Acronym
- EFFECTS
- Status last verified
- Apr 2021
- First submitted
- 27 Oct 2018
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Jan;62(1):221-232. doi: 10.1037/dev0001909. Epub 2025 Jan 9.
PubMed 39786795O'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.
PubMed 38608871EFFECTS 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.
PubMed 38486278Jeong 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.
PubMed 37800367Galvin 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.
PubMed 37023660Ambikapathi 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
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): A Community-Based Bundled Nutrition and Parenting Intervention
- ClinicalTrials.gov ID
- NCT03759821
- Acronym / sponsor ID
- EFFECTS / 01
- Keywords
- Infant and young child feeding, Nutrition, Stimulation, Parenting, Early childhood development, Social and behavior change, Father involvement, Male engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Project Concern InternationalUniversity, hospital or other
- 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
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- 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 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.
| Arm | Type | Receives |
|---|---|---|
| Nutrition, mothers | Experimental | Behavioral: Nutrition, mothersCommunity 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. |
| Nutrition, mothers and fathers | Experimental | Behavioral: Nutrition, mothers and fathersCommunity 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. |
| Nutrition+parenting, mothers | Experimental | Behavioral: Nutrition+parenting, mothersCommunity 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. |
| Nutrition+parenting, mothers and fathers | Experimental | Behavioral: Nutrition+parenting, mothers and fathersCommunity 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. |
| Standard of care control | No intervention | –Local standard of care |
Who may qualify
- Ages
- 0 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- None (only those households not meeting all the above criteria will be excluded from the study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition, mothersNutrition-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 | Behavioural | Nutrition, mothers |
| Nutrition, mothers and fathersNutrition-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 | Behavioural | Nutrition, mothers and fathers |
| Nutrition+parenting, mothersNutrition- 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 | Behavioural | Nutrition+parenting, mothers |
| Nutrition+parenting, mothers and fathersNutrition- 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 | Behavioural | Nutrition+parenting, mothers and fathers |
Primary outcome
Change in child dietary diversity (24 hrs)
Time frame: 12 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 and is assessed in children aged six months or older. A higher score reflects a higher likelihood of reaching a nutritionally adequate diet.
Change in early child development
Time frame: 12 months
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.
21 secondary outcomes
Child dietary diversity (7 days)
Time frame: 12 months
Child nutrition status
Time frame: 12 months
Proportion of children who meet minimum meal frequency guidelines
Time frame: 12 months
Parent-child interactions
Time frame: 12 months
Caregiver early childhood development (ECD) knowledge
Time frame: 12 months
Caregiver infant and young child feeding (IYCF) knowledge
Time frame: 12 months
Change from baseline in household food allocation of animal source foods
Time frame: 12 months
Responsive feeding practices
Time frame: 12 months
Caregiver stimulation practices
Time frame: 12 months
Co-parenting
Time frame: 12 months
Couples' communication (frequency, quality) and decision-making
Time frame: 12 months
Gender equitable attitudes
Time frame: 12 months
Time use patterns
Time frame: 12 months
Proportion of households that purify drinking water
Time frame: 12 months
Proportion of households with observed animal feces in house or compound
Time frame: 12 months
Change in frequency of caregiver handwashing with cleansing agent at critical times during the past 24 hours
Time frame: 12 months
Change in frequency of child handwashing with cleansing agent at critical times during the past 24 hours
Time frame: 12 months
Caregiver water, sanitation, and hygiene (WASH) knowledge
Time frame: 12 months
Maternal and paternal depressive symptoms
Time frame: 12 months
Intimate partner violence (IPV)
Time frame: 12 months
Parenting stress
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 39786795Jeong 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. 2026 Jan;62(1):221-232. doi: 10.1037/dev0001909. Epub 2025 Jan 9.
- Derived from this study: PubMed 38608871O'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.
- Derived from this study: PubMed 38486278EFFECTS 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.
- Derived from this study: PubMed 37800367Jeong 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.
- Derived from this study: PubMed 37023660Galvin 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.
- Derived from this study: PubMed 35317413Ambikapathi 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.
- Individual participant dataSharing planned: No
Related trials for Child Nutrition and Early Child Development
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Not yet recruiting
Implementing Modified Practices to Leverage Evidence for Movement, Engagement, and Nutrition Topics in Early Childcare and Education
Dietary Intakes, Physical Activity
Recruiting
Cooking HEalthy and Facilitating Early Childhood Development: CHEF-ED Study
Teaching Healthy Cooking Skills to Parents and Their Preschool Children
RecruitingObservational study
The Growing Well Study
Dietary Behaviors, Child Growth and Development
Enrolling by invitation
Parent and Infant Inter(X)Action Intervention (PIXI)
Fragile X Syndrome, Angelman Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition, mothers, Nutrition, mothers and fathers and Nutrition+parenting, mothers in people with Child Nutrition and Early Child Development, run by Project Concern International at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child dietary diversity (24 hrs) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03759821, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.