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
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.
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.
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 →Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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Households in one of the two study arms will be eligible for inclusion if they meet all of the following citeria:
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Households receive the standard of care in the area for agricultural and health services.
Nutrition-sensitive intervention using behavior change communication on home gardening, diet, nutrition, WASH, and women's empowerment.
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
Child height/length
Height or length in centimeters
Time frame: 12 and 36 months
Child weight
Weight in kilograms
Time frame: 12 and 36 months
Child MUAC
Mid-upper arm circumference (MUAC) in centimeters
Time frame: 12 and 36 months
Women's Height
Height in centimeters
Time frame: 12 and 36 months
Women's weight
Weight in kilograms
Time frame: 12 and 36 months
Women's MUAC
Mid-upper arm circumference (MUAC) in centimeters
Time frame: 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
Time frame: 12 and 36 months
Hematologic status in children
hemoglobin (Hb) levels cut off points of Hb \< 11 g/dl
Time frame: 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
Time frame: 12 and 36 months
Extent of spillover of home garden behavior
Has a home garden (binary)
Time frame: 12 and 36 months
Extent of spillover of vegetable crop production behavior
Number of vegetables grown in home garden
Time frame: 12 and 36 months
Extent of spillover of production and consumption of crops
Consumed vegetables grown in home garden (binary)
Time frame: 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
Time frame: 12 and 36 months
Plan to share: Undecided
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.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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