NCT06195098

Brief Summary

The TANY VAO project pilot study aimed to create a circular and sustainable model with a multidimensional and multidisciplinary approach to improve the health conditions of Madagascar's population living in rural areas. This is through an integrated approach in the areas of "wash and sanitation," agriculture, nutrition and "clean cooking." This project consisted of two phases: first an observational phase (Work Package 1, WP1) and secondarily an interventional phase (Work Package 2, WP2). Here is described the nutritional protocol as part of the multidisciplinary study. The nutritional activities were conducted by the Laboratory of Dietetics and Clinical Nutrition (LDNC) of the University of Pavia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

December 22, 2023

Last Update Submit

December 22, 2023

Conditions

Keywords

MalnutritionDouble burden of malnutritionSub Saharan AfricaMadagascarEating habitsNutritional knowledgeNutritional statusRural areas

Outcome Measures

Primary Outcomes (1)

  • Improvement of health condition of the study population

    Nutritional assessment, nutrition knowledge and food intake evaluation, and implementation of nutritional intervention.

    6 months (WP1), 18 months (WP2)

Study Arms (1)

Nosy Mitsio Population

OTHER

Women of childbearing age from 14 to 49 years, pregnant or not and lactating or not, and their children and adolescent form 2 to 18 years old.

Other: Nutritional educational intervention

Interventions

The interventional activities were targeted to the local population, according to their educational level and culture and it was composed by a theoretical part and a more practical part. The objective was to improve nutritional knowledge and their awareness about the role of food in connection to the human health. According to the theoretical part: to make the activities more appealing, three informative graphic posters were drafted. According to the practical part: a cooking class activities were conducted, involving women of the Ampanithosa and Bevoko villages. The researchers teaching them how to use a bamboo steamer and how to process vegetables, grew up in the organic gardens built by the Kukula team. The activities were carried out in each village thanks to a local enumerators involvement.

Nosy Mitsio Population

Eligibility Criteria

Age2 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For women: be female, aged between 14 and 49 years and living in the villages of Ampanitosoha and Bevoko (Nosy Mitsio, Madagascar);
  • For children/adolescents: male and female subjects, aged between 2 and 18 years; living in the villages of Ampanitosoha and Bevoko (Nosy Mitsio, Madagascar).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pavia

Pavia, 27100, Italy

Location

Related Links

MeSH Terms

Conditions

MalnutritionFeeding Behavior

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehavior, AnimalBehavior

Study Officials

  • Hellas Cena, MD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of Pavia

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

November 1, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

January 8, 2024

Record last verified: 2023-12

Locations