NCT02914002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

September 22, 2016

Last Update Submit

April 30, 2018

Conditions

Child MalnutritionChild OvernutritionMalnutrition in ChildrenMalnutrition, ChildNutrition Disorders, ChildMalnutrition

Outcome Measures

Primary Outcomes (4)

  • Change in food knowledge and behavior Questionnaire

    Baseline, 1 year

  • Change in Weight

    Baseline, 1 year

  • Change in height

    Baseline, 1 year

  • Change in psychosocial risk Questionnaire

    Baseline, 1 year

Secondary Outcomes (2)

  • Change in capillary hemoglobin

    Baseline, 1 year

  • Change in capillary glucose

    Baseline, 1 year

Study Arms (3)

Psychoeducational intervention

EXPERIMENTAL

Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.

Behavioral: Psychoeducational intervention

Usual Food Practices - AC

NO INTERVENTION

These are participants from the communities where the intervention is active but are not attending the cooking lessons.

Usual Food Practices - NAC

NO INTERVENTION

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

Interventions

Psychoeducational interventionBEHAVIORAL

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.

Also known as: Psychoeducational intervention in nutrition
Psychoeducational intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or breastfeeding
  • With a hysterectomy in the past 3 months
  • Alcohol consumption \> 14 drinks a week
  • Use of vitamin supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banco de Alimentos de Mexico

México, 06700, Mexico

Location

MeSH Terms

Conditions

Child Nutrition DisordersMalnutrition

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Ana Carla Cepeda-Lopez, PhD

    Universidad de Monterrey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 26, 2016

Study Start

June 1, 2016

Primary Completion

December 19, 2017

Study Completion

March 1, 2018

Last Updated

May 3, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)