MalnutritionNCT06195098
The Tany Vao Project.
A study testing Nutritional educational intervention in people with Malnutrition, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 2 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutritional educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Any person who does not fall under the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Nutritional educational intervention
- Keywords
- Malnutrition, Double burden of malnutrition, Sub Saharan Africa, Madagascar, Eating habits, Nutritional knowledge, Nutritional status, Rural areas
- Medical subject headings
- Malnutrition, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional educational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nutritional educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of health condition of the study population
Nutritional assessment, nutrition knowledge and food intake evaluation, and implementation of nutritional intervention.
Measured: 6 months (WP1), 18 months (WP2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Nov 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Help for optimism NGO, Kukula ONLUS, Elpis Nave Ospedale ONLUS
- Responsible party
- Principal investigator, Hellas Cena, University of Pavia
- Investigators
- Hellas Cena, MD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195098
- Sponsor's protocol ID
- 04122023
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary and Sustainable Intervention Study Aimed at Rural Area of Madagascar: the Tany Vao Project.
- ClinicalTrials.gov ID
- NCT06195098
- Acronym / sponsor ID
- 04122023
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Double burden of malnutrition, Sub Saharan Africa, Madagascar, Eating habits, Nutritional knowledge, Nutritional status, Rural areas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Help for optimism NGO, Kukula ONLUS, Elpis Nave Ospedale ONLUS
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nosy Mitsio Population | Other | Other: Nutritional educational interventionWomen 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. |
Who may qualify
- Ages
- 2 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Any person who does not fall under the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional educational interventionThe 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. | Other | Nosy Mitsio Population |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Help for Optimism project descriptionLink provided by the sponsor.
- Kukula project descriptionLink provided by the sponsor.
Related trials for Malnutrition
Not yet recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hellas Cena, MD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional educational intervention in people with Malnutrition, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of health condition of the study population (time frame: 6 months (WP1), 18 months (WP2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.