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Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings

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ClinicalTrials.gov Identifier: NCT02914002
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Fundación FEMSA A.C.
Mexican Food Banks
Information provided by (Responsible Party):
Universidad de Monterrey

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Child Malnutrition Child Overnutrition Malnutrition in Children Malnutrition, Child Nutrition Disorders, Child Malnutrition Behavioral: Psychoeducational intervention Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in 15 Low Resource Populations Through a Network of Food Banks in Mexico.
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : March 1, 2018

Arm Intervention/treatment
Experimental: Psychoeducational intervention
Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.
Behavioral: Psychoeducational intervention
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 Name: Psychoeducational intervention in nutrition

No Intervention: Usual Food Practices - AC
These are participants from the communities where the intervention is active but are not attending the cooking lessons.
No Intervention: Usual Food Practices - NAC
These are participants from a community where the intervention is not active.



Primary Outcome Measures :
  1. Change in food knowledge and behavior Questionnaire [ Time Frame: Baseline, 1 year ]
  2. Change in Weight [ Time Frame: Baseline, 1 year ]
  3. Change in height [ Time Frame: Baseline, 1 year ]
  4. Change in psychosocial risk Questionnaire [ Time Frame: Baseline, 1 year ]

Secondary Outcome Measures :
  1. Change in capillary hemoglobin [ Time Frame: Baseline, 1 year ]
    Capillary blood sample

  2. Change in capillary glucose [ Time Frame: Baseline, 1 year ]
    Capillary blood sample



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914002


Locations
Mexico
Banco de Alimentos de Mexico
Mexico, Mexico, 06700
Sponsors and Collaborators
Universidad de Monterrey
Fundación FEMSA A.C.
Mexican Food Banks
Investigators
Principal Investigator: Ana Carla Cepeda-Lopez, PhD Universidad de Monterrey

Responsible Party: Universidad de Monterrey
ClinicalTrials.gov Identifier: NCT02914002     History of Changes
Other Study ID Numbers: 502016-CIE
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Overnutrition
Child Nutrition Disorders