- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258802
Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings
May 11, 2016 updated by: Universidad de Monterrey
A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in a Pilot Low Resource Population in the City of Saltillo, Coahuila Mexico.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Psychoeducational intervention
Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.
|
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.
Other Names:
|
NO_INTERVENTION: Usual food practices
These are participants from the communities where the intervention is active but are not attending the cooking lessons.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in food knowledge and behaviour
Time Frame: baseline, 6 months, 1 year
|
questionnaire
|
baseline, 6 months, 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vegetable intake
Time Frame: baseline, 1 year
|
24 hour recall
|
baseline, 1 year
|
Change in dietary practices
Time Frame: baseline, 6 months, 1 year
|
questionnaire
|
baseline, 6 months, 1 year
|
Change in food waste
Time Frame: baseline, 6 months, 1 year
|
questionnaire
|
baseline, 6 months, 1 year
|
Change in cognitive development in children
Time Frame: baseline, 1 year
|
questionnaire
|
baseline, 1 year
|
Change in anthropometry
Time Frame: baseline, 6 months, 1 year
|
weight, height and waist circumference
|
baseline, 6 months, 1 year
|
Change in micronutrient status
Time Frame: baseline, 1 year
|
serum sample
|
baseline, 1 year
|
Change in inflammatory markers
Time Frame: baseline, 1 year
|
serum sample
|
baseline, 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
September 30, 2014
First Submitted That Met QC Criteria
October 2, 2014
First Posted (ESTIMATE)
October 7, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102014-CIE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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