The Tany Vao Project.

December 22, 2023 updated by: Hellas Cena, University of Pavia

A Multidisciplinary and Sustainable Intervention Study Aimed at Rural Area of Madagascar: the Tany Vao Project.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The TANY VAO project pilot study aims 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."

Here is described the nutritional protocol as part of the multidisciplinary study.

The TANY VAO project was conducted on the island of Nosy Mitsio, 20 miles west of Madagascar, in the villages of Ampanitosoha and Bevoko (western part of the island) on a group of women of childbearing age and their children.

Participants of this study were women of childbearing age (14-49 years old), pregnant or not, and their male or female children/adolescents (2-18 years old) living in the Ampanitosoha and in the Bevoko villages.

Focusing on the nutritional activities the main outcome was to improve food knowledge, eating habits and dietary diversity of the population enrolled in the study.

The project was composed by two different work packages (WP).

WP1: observational phase During this phase researcher were able to catch a picture of the current situation in this specific rural area of Madagascar from a nutritional assessment point of view. Sociodemographic information (religion, civil status, age, educational level) was collected and nutritional knowledge (9-items questionnaire), eating habits (24 hour recall and food frequency), and dietary diversity (minimum dietary diversity index for women) were assessed for women exclusively. A nutritional assessment was conducted for both women and children/adolescents (women: weight, height, abdominal and waist circumference, mid-upper arm circumference, skin fold; children: weight, height, mid-upper arm circumference).

WP2: interventional phase Based on the results of WP1, the interventional activities were defined. 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. The posters provided guidance 1) on food safety and hygiene, 2) on making a complete meal from local foods and practical nutritional advices, and 3) specific indications for the pregnancy and lactation period.

According to the practical part: a cooking class activities were conducted, involving women of the Ampanithosa and Bevoko villages. The researchers taught 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.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Any person who does not fall under the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nosy Mitsio Population
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of health condition of the study population
Time Frame: 6 months (WP1), 18 months (WP2)
Nutritional assessment, nutrition knowledge and food intake evaluation, and implementation of nutritional intervention.
6 months (WP1), 18 months (WP2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Collaborators

Help for optimism NGO
Kukula ONLUS
Elpis Nave Ospedale ONLUS

Investigators

  • Principal Investigator: Hellas Cena, MD, University of Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04122023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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