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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06195098
Other study ID # 04122023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date November 30, 2023

Study information

Verified date December 2023
Source University of Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 141
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy University of Pavia Pavia

Sponsors (4)

Lead Sponsor Collaborator
University of Pavia Elpis Nave Ospedale ONLUS, Help for optimism NGO, Kukula ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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