AzTrials
AzTrials

Diet ModificationHANUNCT03311698

Homestead Agriculture and Nutrition Project

A study testing Nutrition-sensitive intervention in people with Diet Modification and Health Behavior, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Diet Modification, Health Behavior
What is being tested?
Nutrition-sensitive intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,007 participants
Where
1 siteTanzania
Study dates
20 Jul 2016to 30 Sep 2019
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 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Tanzania1 site
  • Ifakara Health Institute

    Dar es Salaam, Mikocheni

Other trials in Tanzania

About this study

Official title: Homestead Agriculture and Nutrition Project in Rufiji District, Tanzania

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.

Being tested
Nutrition-sensitive intervention
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition-sensitive interventionBehavioural

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

Study groups in NCT03311698
Study groupRoleWhat they receive
InterventionExperimentalHouseholds 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.
Receives: Behavioral: Nutrition-sensitive intervention
ControlNo interventionHouseholds receive the standard of care in the area for agricultural and health services.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 and 36 months

Secondary outcomes (13)
  1. Child height/length

    Height or length in centimeters

    Measured: 12 and 36 months

  2. Child weight

    Weight in kilograms

    Measured: 12 and 36 months

  3. Child MUAC

    Mid-upper arm circumference (MUAC) in centimeters

    Measured: 12 and 36 months

  4. Women's Height

    Height in centimeters

    Measured: 12 and 36 months

  5. Women's weight

    Weight in kilograms

    Measured: 12 and 36 months

  6. Women's MUAC

    Mid-upper arm circumference (MUAC) in centimeters

    Measured: 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

    Measured: 12 and 36 months

  8. Hematologic status in children

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

    Measured: 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

    Measured: 12 and 36 months

  10. Extent of spillover of home garden behavior

    Has a home garden (binary)

    Measured: 12 and 36 months

  11. Extent of spillover of vegetable crop production behavior

    Number of vegetables grown in home garden

    Measured: 12 and 36 months

  12. Extent of spillover of production and consumption of crops

    Consumed vegetables grown in home garden (binary)

    Measured: 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

    Measured: 12 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start20 Jul 2016
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
1,007 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03311698
Sponsor's protocol ID
HSPH-16-0397
Acronym
HANU
Status last verified
Jul 2020
First submitted
27 Sep 2017
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition-sensitive intervention in people with Diet Modification and Health Behavior, run by Harvard School of Public Health (HSPH) 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 0 inclusion and 4 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 14 Jul 2020. 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?

Dietary diversity defined as number of food groups consumed out of 10 (time frame: 12 and 36 months). 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 NCT03311698, which also lists 2 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 14 Jul 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in