Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings

Malnutrition Clinical Trial

Official title:

A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in a Pilot Low Resource Population in the City of Saltillo, Coahuila Mexico.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258802
• Other study ID #: 102014-CIE
• Status: Completed
• Phase: N/A
• First received: September 30, 2014
• Last updated: May 11, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Universidad de Monterrey
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop, implement and evaluate a psychoeducational intervention focused to improve nutritional status, specifically micronutrients, of mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities.

Description:

Mexico's malnutrition problem goes beyond lack of food. Nutrition transition in our country has modified dietary patterns in a way that now we observe more and more a decrease in consumption of micronutrient rich foods, like vegetables, and an increase in consumption of high energy-dense foods with low content of micronutrients (highly processed foods). In Mexico, over 70% of the population presents an inadequate vegetable intake, with a higher prevalence in scholars (5 - 11 years), where only 17% of them consume >50% of the recommended vegetable intake. A vegetable poor diet is related to malnutrition, poor cognitive development and low physical performance. Added to this, Mexican families have lost the tradition of cooking at home. It is well known that different factors contribute to a population's diet and cooking at home as well as eating with the family have been identified as fundamental factors to promote a healthy diet. Therefore, the aim of this psychoeducational intervention in nutrition is to improve nutritional status in families, particularly mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities where the optimal preparation and use of local foods based on vegetables is promoted at the same time the importance of cooking at home and eating as a family is highlighted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18 to 60 years

• Premenopausal

• BMI < 45 during enrollment

• Apparently healthy

• With a child in her care between the ages of 5 and 13 years

Exclusion Criteria:

• Pregnant or breastfeeding

• With a hysterectomy in the past 3 months

• Alcohol consumption > 14 drinks a week

• Use of vitamin supplements

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Child Overnutrition
• Malnutrition
• Malnutrition in Children
• Malnutrition, Child
• Nutrition Disorders
• Nutrition Disorders, Child
• Overnutrition

Intervention

Behavioral:
• Psychoeducational intervention
A mobile kitchen visits the 5 selected communities every 2 weeks for a period of 1 year. A 30 minute cooking lesson is given by a trained instructor, the recipes have been designed to be quick and easy to make, use local and inexpensive ingredients, contain mostly vegetables and have a good taste. During the lesson, healthy habit and cooking tips are mentioned. A printed version of the recipe is given to every participant. Every lesson a different participant is encouraged to help prepare the recipe. At the end of the lesson all the participants get to taste the meal and express their opinion.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Monterrey	Fundación FEMSA A.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in food knowledge and behaviour	questionnaire	baseline, 6 months, 1 year	No
Secondary	Change in vegetable intake	24 hour recall	baseline, 1 year	No
Secondary	Change in dietary practices	questionnaire	baseline, 6 months, 1 year	No
Secondary	Change in food waste	questionnaire	baseline, 6 months, 1 year	No
Secondary	Change in cognitive development in children	questionnaire	baseline, 1 year	No
Secondary	Change in anthropometry	weight, height and waist circumference	baseline, 6 months, 1 year	No
Secondary	Change in micronutrient status	serum sample	baseline, 1 year	Yes
Secondary	Change in inflammatory markers	serum sample	baseline, 1 year	Yes