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
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
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
NCT ID
NCT02258802
First Posted
September 30, 2014
Last Updated
May 11, 2016
Sponsor
Universidad de Monterrey
Collaborators
FEMSA Foundation
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
Learn more about this trial
Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings
We'll reach out to this number within 24 hrs