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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Diet Modification, Health Behavior
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Nutrition-sensitive intervention |
| Control | No intervention | Households 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.
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)
Child height/length
Height or length in centimeters
Measured: 12 and 36 months
Child weight
Weight in kilograms
Measured: 12 and 36 months
Child MUAC
Mid-upper arm circumference (MUAC) in centimeters
Measured: 12 and 36 months
Women's Height
Height in centimeters
Measured: 12 and 36 months
Women's weight
Weight in kilograms
Measured: 12 and 36 months
Women's MUAC
Mid-upper arm circumference (MUAC) in centimeters
Measured: 12 and 36 months
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
Hematologic status in children
hemoglobin (Hb) levels cut off points of Hb < 11 g/dl
Measured: 12 and 36 months
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
Extent of spillover of home garden behavior
Has a home garden (binary)
Measured: 12 and 36 months
Extent of spillover of vegetable crop production behavior
Number of vegetables grown in home garden
Measured: 12 and 36 months
Extent of spillover of production and consumption of crops
Consumed vegetables grown in home garden (binary)
Measured: 12 and 36 months
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.
- First posted17 Oct 2017
- Study start20 Jul 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MBBS, DrPH, Principal investigator, Harvard School of Public Health (HSPH)Honorati Masanja, PhD, Principal investigator, Ifakara Health Institute
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 33241924Mosha 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homestead Agriculture and Nutrition Project in Rufiji District, Tanzania
- ClinicalTrials.gov ID
- NCT03311698
- Acronym / sponsor ID
- HANU / HSPH-16-0397
- Conditions
- Diet Modification, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Ifakara Health Institute
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 Oct 2017 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nutrition-sensitive interventionHouseholds 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. |
| Control | No intervention | –Households receive the standard of care in the area for agricultural and health services. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
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-sensitive interventionNutrition-sensitive intervention using behavior change communication on home gardening, diet, nutrition, WASH, and women's empowerment. | Behavioural | Intervention |
Primary outcome
Dietary diversity defined as number of food groups consumed out of 10
Time frame: 12 and 36 months
Minimum dietary diversity for women of reproductive age defined as a minimum of 5 food groups consumed out of 10
13 secondary outcomes
Child height/length
Time frame: 12 and 36 months
Child weight
Time frame: 12 and 36 months
Child MUAC
Time frame: 12 and 36 months
Women's Height
Time frame: 12 and 36 months
Women's weight
Time frame: 12 and 36 months
Women's MUAC
Time frame: 12 and 36 months
Hematologic status in women
Time frame: 12 and 36 months
Hematologic status in children
Time frame: 12 and 36 months
Child dietary diversity
Time frame: 12 and 36 months
Extent of spillover of home garden behavior
Time frame: 12 and 36 months
Extent of spillover of vegetable crop production behavior
Time frame: 12 and 36 months
Extent of spillover of production and consumption of crops
Time frame: 12 and 36 months
Early Childhood Development
Time frame: 12 and 36 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 14 Jul 2020.
- Derived from this study: PubMed 33241924Blakstad 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.
- Derived from this study: PubMed 32153890Mosha 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.
- Individual participant dataSharing planned: Undecided
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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.
Wafaie W Fawzi, MBBS, DrPH principal investigator
Harvard School of Public Health (HSPH)
Honorati Masanja, PhD principal investigator
Ifakara Health Institute
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-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.