NCT03311698

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,007

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

September 27, 2017

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

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

    12 and 36 months

Secondary Outcomes (13)

  • Child height/length

    12 and 36 months

  • Child weight

    12 and 36 months

  • Child MUAC

    12 and 36 months

  • Women's Height

    12 and 36 months

  • Women's weight

    12 and 36 months

  • +8 more secondary outcomes

Study Arms (2)

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.

Behavioral: Nutrition-sensitive intervention

Control

NO INTERVENTION

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

Interventions

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

Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be a women of reproductive age
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifakara Health Institute

Dar es Salaam, Mikocheni, Tanzania

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Wafaie W Fawzi, MBBS, DrPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR
  • Honorati Masanja, PhD

    Ifakara Health Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Global Health and Population

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 17, 2017

Study Start

July 20, 2016

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations