search
Back to results

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
Mexico
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

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Banco de Alimentos de Mexico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Psychoeducational intervention

Usual Food Practices - AC

Usual Food Practices - NAC

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.

These are participants from a community where the intervention is not active.

Outcomes

Primary Outcome Measures

Change in food knowledge and behavior Questionnaire
Change in Weight
Change in height
Change in psychosocial risk Questionnaire

Secondary Outcome Measures

Change in capillary hemoglobin
Capillary blood sample
Change in capillary glucose
Capillary blood sample

Full Information

First Posted
September 22, 2016
Last Updated
April 30, 2018
Sponsor
Universidad de Monterrey
Collaborators
FEMSA Foundation, Mexican Food Banks
search

1. Study Identification

Unique Protocol Identification Number
NCT02914002
Brief Title
Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12400 (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 - AC
Arm Type
No Intervention
Arm Description
These are participants from the communities where the intervention is active but are not attending the cooking lessons.
Arm Title
Usual Food Practices - NAC
Arm Type
No Intervention
Arm Description
These are participants from a community where the intervention is not active.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational intervention
Other Intervention Name(s)
Psychoeducational intervention in nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in food knowledge and behavior Questionnaire
Time Frame
Baseline, 1 year
Title
Change in Weight
Time Frame
Baseline, 1 year
Title
Change in height
Time Frame
Baseline, 1 year
Title
Change in psychosocial risk Questionnaire
Time Frame
Baseline, 1 year
Secondary Outcome Measure Information:
Title
Change in capillary hemoglobin
Description
Capillary blood sample
Time Frame
Baseline, 1 year
Title
Change in capillary glucose
Description
Capillary blood sample
Time Frame
Baseline, 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
Facility Information:
Facility Name
Banco de Alimentos de Mexico
City
Mexico
ZIP/Postal Code
06700
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings

We'll reach out to this number within 24 hrs