ClinicalTrials.gg
CompletedNCT03311698HANUUpdated Jul 14, 2020

Homestead Agriculture and Nutrition Project

An interventional study of Nutrition-sensitive intervention in Diet Modification and Health Behavior, sponsored by Harvard School of Public Health (HSPH). Completed at 1 site in Tanzania. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jul 2016, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
1,007
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

HANU is an evaluation of the effects of an integrated, gender-focused nutrition-sensitive intervention on the nutrition and health of young children and women of reproductive age in rural Tanzania.

Read the detailed description

HANU aims to develop, implement, and evaluate nutrition-sensitive interventions among rural smallholder households in Rufiji Tanzania with the goal of improving the nutritional status and health of young children and women of reproductive age. Specifically, HANU will engage agricultural extension workers (AEWs) and community health workers (CHWs) to provide an integrated homestead food production, nutrition counselling, and public health intervention.

Households receiving the intervention will receive (1) Interventions to promote homestead food production, increase agricultural production and food diversity, (2) nutritional counselling, including locally adapted instructions on the mix and quantity of food suitable for children of ages 6-24 months, and (3) a health-focused intervention, including information on micronutrient supplementation, integrated management of child illnesses, and prevention and management of child malnutrition with a focus on the first 1,000 days. The intervention will include information on cultivation of nutrient-rich crop varieties, best practices for home gardening, safe water, sanitation, and hygiene practices (WASH), breastfeeding and complementary feeding, dietary intake and nutrition, and other basic public health messages. There are two delivery mechanisms for the intervention: farmer field schools and households visits. Household visits are conducted approximately bimonthly separately by AEWs and CHWs. Field schools are held approximately bimonthly and attended by both AEWs and CHWs. Households enrolled in the intervention will also receive agricultural inputs such as seeds, fertilizer, and watering cans.

Through this package of interventions, HANU aims to address the three primary pathways of impacting nutrition through agriculture: gender, income, and consumption. The interventions are designed to increase women's input into decision making over crop production and food consumption, child feeding, use of income, WASH practices, knowledge of nutrition and healthy diets; and home gardening skills. It also aims to address market barriers to homestead food production through connecting participants with agricultural services and helping to generate income through crop production.

The effects of the intervention will be evaluated through a cluster-randomized study design. Ten villages will be randomly selected and paired based on location, proximity to water, and population size. One village in each pair will be randomly assigned to receive the intervention (total of five villages) and one to the control group (total of five villages). Approximately 500 households in each arm will be screened, consented, and enrolled. Data will be collected by trained interviewers using surveys administered with electronic tablets at three time points, once at baseline, once 12 months after intervention implementation, and once approximately 36 months after intervention implementation. Anthropometric measurements of women and young children will be taken at three time points. Hemoglobin for women and young children will be measured among a subset of the study population at three time points.

Qualitative methods will be used to explore barriers to adopting the behaviors promoted through the intervention. One focus group discussion with study participants in each intervention village will be conducted to explore participant experiences with the interventions including key challenges. Eight key informant interviews will further assess sustainability aspects of the intervention.

It is possible that the adoption of home gardening practices and other positive nutrition and health behaviors could spillover to neighboring households. Therefore this study will also assess potential spillover effects of the intervention. In each intervention village, households that did not receive the intervention will be enrolled to assess potential spillover effects of the intervention through the use of a quantitative survey. Approximately 450 households will be enrolled and data will be collected at two time points 12 months after intervention implementation and 36 months after intervention implementation. One focus group discussion in each intervention village among households that did not receive the intervention will be conducted to further explore spillover effects.

02

Conditions studied

  • Diet Modification
  • Health Behavior

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03

In context

Health Behavior

968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.

This study's enrollment of 1,007 is above the median of 150 across 825 interventional studies indexed under Health Behavior.

Browse Health Behavior studies →

Lead sponsor

Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Households in one of the two study arms will be eligible for inclusion if they meet all of the following citeria:

  • Provide
  • Households with women of reproductive age and with at least one child under the age of 36 months (10 years for spillover households to ascertain the secondary outcomes of extent of spillover).
  • Household has access to plot of land or containers where vegetables could be grown
  • Households that speak and understand English or Swahili

Exclusion Criteria:

  • Do not provide informed consent
  • Households without a woman of reproductive age or a child under the age of 36 months (10 years for spillover households).
  • Households without access to plot of land or containers where vegetables could be grown.
  • Households that do not speak and understand English or Swahili.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,007 participants (actual)

Study arms

  • Experimental
    Intervention

    Households receiving the intervention will receive (1) Interventions to promote homestead food production, increase agricultural production and food diversity, (2) nutritional counselling, including locally adapted instructions on the mix and quantity of food suitable for children of ages 6-24 months, and (3) a health-focused intervention, including information on micronutrient supplementation, integrated management of child illnesses, and prevention and management of child malnutrition with a focus on the first 1,000 days.

    Behavioral: Nutrition-sensitive intervention

  • No intervention
    Control

    Households receive the standard of care in the area for agricultural and health services.

Interventions

  • BehavioralNutrition-sensitive intervention

    Nutrition-sensitive intervention using behavior change communication on home gardening, diet, nutrition, WASH, and women's empowerment.

06

What researchers measure

Primary outcomes

  1. Dietary diversity defined as number of food groups consumed out of 10

    Minimum dietary diversity for women of reproductive age defined as a minimum of 5 food groups consumed out of 10

    Time frame: 12 and 36 months

Secondary outcomes

  1. Child height/length

    Height or length in centimeters

    Time frame: 12 and 36 months

  2. Child weight

    Weight in kilograms

    Time frame: 12 and 36 months

  3. Child MUAC

    Mid-upper arm circumference (MUAC) in centimeters

    Time frame: 12 and 36 months

  4. Women's Height

    Height in centimeters

    Time frame: 12 and 36 months

  5. Women's weight

    Weight in kilograms

    Time frame: 12 and 36 months

  6. Women's MUAC

    Mid-upper arm circumference (MUAC) in centimeters

    Time frame: 12 and 36 months

  7. Hematologic status in women

    hemoglobin (Hb) levels cut off points of Hb \< 12 g/dl for non pregnant women and Hb \< 11g/dl for pregnant women

    Time frame: 12 and 36 months

  8. Hematologic status in children

    hemoglobin (Hb) levels cut off points of Hb \< 11 g/dl

    Time frame: 12 and 36 months

  9. Child dietary diversity

    Minimum dietary diversity for children under 4 years of age as defined by number of food groups consumed out of 10

    Time frame: 12 and 36 months

  10. Extent of spillover of home garden behavior

    Has a home garden (binary)

    Time frame: 12 and 36 months

  11. Extent of spillover of vegetable crop production behavior

    Number of vegetables grown in home garden

    Time frame: 12 and 36 months

  12. Extent of spillover of production and consumption of crops

    Consumed vegetables grown in home garden (binary)

    Time frame: 12 and 36 months

  13. Early Childhood Development

    Early Childhood Development (ECD) as measured by the Caregiver Reported Early Development Index (CREDI) using a continuous score of overall developmental status

    Time frame: 12 and 36 months

07

Study locations

1 site
  • Ifakara Health Institute
    Dar es Salaam, Mikocheni, Tanzania
08

References and documents

Publications

  • Blakstad MM, Mosha D, Bellows AL, Canavan CR, Chen JT, Mlalama K, Noor RA, Kinabo J, Masanja H, Fawzi WW. Home gardening improves dietary diversity, a cluster-randomized controlled trial among Tanzanian women. Matern Child Nutr. 2021 Apr;17(2):e13096. doi: 10.1111/mcn.13096. Epub 2020 Nov 26. PubMed 33241924 ↗
  • Mosha D, Canavan CR, Bellows AL, Blakstad MM, Noor RA, Masanja H, Kinabo J, Fawzi W. The impact of integrated nutrition-sensitive interventions on nutrition and health of children and women in rural Tanzania: study protocol for a cluster-randomized controlled trial. BMC Nutr. 2018 Sep 6;4:29. doi: 10.1186/s40795-018-0238-7. eCollection 2018. PubMed 32153890 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2016 to primary completion in Sep 2019, 38 months.

Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 38 months is above that.

Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2017
First posted
Oct 17, 2017
StartActual
Jul 20, 2016
Primary completionActual
Sep 30, 2019
CompletionActual
Sep 30, 2019
Last update
Jul 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03311698
Collaborators
Ifakara Health Institute
Responsible party
Wafaie Fawzi (Chair, Department of Global Health and Population, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
Oct 17, 2017
Start date
Jul 20, 2016
Primary completion
Sep 30, 2019
Completion
Sep 30, 2019
Last update
Jul 14, 2020

Study contacts

Wafaie W Fawzi, MBBS, DrPH
principal investigator · Harvard School of Public Health (HSPH)
Honorati Masanja, PhD
principal investigator · Ifakara Health Institute

Oversight

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

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