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

Primary Purpose

Child Malnutrition, Child Overnutrition, Malnutrition in Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychoeducational intervention
Sponsored by
Universidad de Monterrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Malnutrition focused on measuring psychoeducational intervention, nutrition intervention, malnutrition, micronutrient deficiency, nutrition transition

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Psychoeducational intervention

    Usual food practices

    Arm Description

    Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.

    These are participants from the communities where the intervention is active but are not attending the cooking lessons.

    Outcomes

    Primary Outcome Measures

    Change in food knowledge and behaviour
    questionnaire

    Secondary Outcome Measures

    Change in vegetable intake
    24 hour recall
    Change in dietary practices
    questionnaire
    Change in food waste
    questionnaire
    Change in cognitive development in children
    questionnaire
    Change in anthropometry
    weight, height and waist circumference
    Change in micronutrient status
    serum sample
    Change in inflammatory markers
    serum sample

    Full Information

    First Posted
    September 30, 2014
    Last Updated
    May 11, 2016
    Sponsor
    Universidad de Monterrey
    Collaborators
    FEMSA Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02258802
    Brief Title
    Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad de Monterrey
    Collaborators
    FEMSA Foundation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Child Malnutrition, Child Overnutrition, Malnutrition in Children, Malnutrition, Child, Nutrition Disorders, Child, Malnutrition
    Keywords
    psychoeducational intervention, nutrition intervention, malnutrition, micronutrient deficiency, nutrition transition

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psychoeducational intervention
    Arm Type
    Experimental
    Arm Description
    Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.
    Arm Title
    Usual food practices
    Arm Type
    No Intervention
    Arm Description
    These are participants from the communities where the intervention is active but are not attending the cooking lessons.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducational intervention
    Other Intervention Name(s)
    Psychoeducational intervention in nutrition
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in food knowledge and behaviour
    Description
    questionnaire
    Time Frame
    baseline, 6 months, 1 year
    Secondary Outcome Measure Information:
    Title
    Change in vegetable intake
    Description
    24 hour recall
    Time Frame
    baseline, 1 year
    Title
    Change in dietary practices
    Description
    questionnaire
    Time Frame
    baseline, 6 months, 1 year
    Title
    Change in food waste
    Description
    questionnaire
    Time Frame
    baseline, 6 months, 1 year
    Title
    Change in cognitive development in children
    Description
    questionnaire
    Time Frame
    baseline, 1 year
    Title
    Change in anthropometry
    Description
    weight, height and waist circumference
    Time Frame
    baseline, 6 months, 1 year
    Title
    Change in micronutrient status
    Description
    serum sample
    Time Frame
    baseline, 1 year
    Title
    Change in inflammatory markers
    Description
    serum sample
    Time Frame
    baseline, 1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Carla Cepeda-Lopez, PhD
    Organizational Affiliation
    Universidad de Monterrey
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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