- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914002
Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings
April 30, 2018 updated by: Universidad de Monterrey
A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in 15 Low Resource Populations Through a Network of Food Banks in Mexico.
Comer en Familia is a psychoeducational intervention in nutrition aimed 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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It is well known that in order to promote a proper nutrition and to prevent malnutrition in Mexican population, both by deficiencies and excesses, it is essential to recover Mexican food culture.
It is known that only information is insufficient to implement healthy lifestyles.
There are a number of barriers that interfere with the adoption of healthy dietary practices that need to be identified and addressed in order to achieve the adoption of healthy eating behaviors.
Therefore, Comer en Familia focuses on the people, their lifestyles, motivations and social context, based on an action methodology.
To design the program, culinary traditions from different country regions were integrated, the habits of proper food preparation at home, promoting eating in the company of family with special emphasis on the importance of enjoying the taste of food were also integrated.
This model delivers information on the transcendence of preparing food at home, the impact of nutrients on health and the influence of eating habits of the family in the conducts of their members in a practical way.
Comer en Familia is a nutritional educational model that aims to promote proper nutrition, and therefore improve health and welfare of the beneficiaries of food banks.
Through 24 cooking workshops throughout a period of a year, each workshop every 15 days, communities will be trained in optimal food preparation and the use of local food, based mainly on vegetables, while promoting the importance of cooking and having family meals.
Anthropometric evaluations and interviews on food practices will be conducted to the beneficiaries at the beginning and at the end of the program.
Anthropometric evaluations will be carried out and psychosocial risks surveys will be applied to the children in charge of the mothers/ caregivers from Comer en Familia.
Also, in a sub-sample of the population of mothers/caregivers benefitted from the program, fasting capillary glucose and hemoglobin will be measured at the beginning and at the end of Comer en Familia.
Study Type
Interventional
Enrollment (Actual)
12400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Mexico, Mexico, 06700
- Banco de Alimentos de Mexico
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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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age 18 to 50 years
- Premenopausal
- Related to the decision of purchase, planning, elaboration-preparation of meals at home.
- Not being pregnant during the period of the study or the six prior months, and planning not to be pregnant at least 3 months after the last visit of the study.
- With a child in her care between the ages of 5 and 13 years and that fulfills the inclusion criteria
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 Assignment
- Masking: None (Open Label)
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.
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A mobile kitchen visits the 16 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 as well as the importance of cooking at home and having family meals .
A printed version of the recipe is given to every participant.
Every session participants are encouraged to prepare the recipe.
At the end of the lesson all the participants get to taste the meal and express their opinion.
Other Names:
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No Intervention: Usual Food Practices - AC
These are participants from the communities where the intervention is active but are not attending the cooking lessons.
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No Intervention: Usual Food Practices - NAC
These are participants from a community where the intervention is not active.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in food knowledge and behavior Questionnaire
Time Frame: Baseline, 1 year
|
Baseline, 1 year
|
Change in Weight
Time Frame: Baseline, 1 year
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Baseline, 1 year
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Change in height
Time Frame: Baseline, 1 year
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Baseline, 1 year
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Change in psychosocial risk Questionnaire
Time Frame: Baseline, 1 year
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Baseline, 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in capillary hemoglobin
Time Frame: Baseline, 1 year
|
Capillary blood sample
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Baseline, 1 year
|
Change in capillary glucose
Time Frame: Baseline, 1 year
|
Capillary blood sample
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Baseline, 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 1, 2016
Primary Completion (Actual)
December 19, 2017
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (Estimate)
September 26, 2016
Study Record Updates
Last Update Posted (Actual)
May 3, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502016-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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