Clinical trial NCT02914002: 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
Overall status: COMPLETED
Phase: NA
Conditions: Child Malnutrition
Child Overnutrition
Malnutrition in Children
Malnutrition, Child
Nutrition Disorders, Child
Malnutrition
Lead sponsor: Universidad de Monterrey
Sponsor class: OTHER
Collaborators: name: FEMSA Foundation
name: Mexican Food Banks
First posted: 2016-09-26
Enrollment: 12400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in food knowledge and behavior Questionnaire
timeFrame: Baseline, 1 year
measure: Change in Weight
timeFrame: Baseline, 1 year
measure: Change in height
timeFrame: Baseline, 1 year
measure: Change in psychosocial risk Questionnaire
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Change in capillary hemoglobin
timeFrame: Baseline, 1 year
measure: Change in capillary glucose
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Banco de Alimentos de Mexico
Study officials:
affiliation: Universidad de Monterrey
name: Ana Carla Cepeda-Lopez, PhD
role: PRINCIPAL_INVESTIGATOR
References: