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CompletedNCT02914002Updated May 3, 2018

Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings

An interventional study of Psychoeducational intervention in Child Malnutrition, Child Overnutrition and Malnutrition in Children, sponsored by Universidad de Monterrey. Completed at 1 site in Mexico. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-03.

Sponsored by Universidad de Monterrey · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2016, registered Sep 2016).

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Phase
Not applicable
Study type
Interventional
Enrollment
12,400
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Child Malnutrition
  • Child Overnutrition
  • Malnutrition in Children
  • Malnutrition, Child
  • Nutrition Disorders, Child
  • Malnutrition
03

In context

Child Nutrition Disorders

168 studies on the registry are indexed under Child Nutrition Disorders; 35 are open to participants now.

This study's enrollment of 12,400 is above the median of 400 across 133 interventional studies indexed under Child Nutrition Disorders.

Browse Child Nutrition Disorders studies →

Lead sponsor

Universidad de Monterrey is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnant or breastfeeding
  • With a hysterectomy in the past 3 months
  • Alcohol consumption > 14 drinks a week
  • Use of vitamin supplements
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12,400 participants (actual)

Study arms

  • Experimental
    Psychoeducational intervention

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

    Behavioral: Psychoeducational intervention

  • 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.

Interventions

  • BehavioralPsychoeducational 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.

    Also known as: Psychoeducational intervention in nutrition

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Change in capillary hemoglobin

    Capillary blood sample

    Time frame: Baseline, 1 year

  2. Change in capillary glucose

    Capillary blood sample

    Time frame: Baseline, 1 year

07

Study locations

1 site
  • Banco de Alimentos de Mexico
    Mexico, 06700, Mexico
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Dec 2017, 18 months.

Of 82 non-industry interventional studies with no phase under Child Nutrition Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 18 months is close to that.

Counting every sponsor, half of 85 studies reached it within 19 months; a quarter within 11 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2016
First posted
Sep 26, 2016
StartActual
Jun 2016
Primary completionActual
Dec 19, 2017
CompletionActual
Mar 1, 2018
Last update
May 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02914002
Lead sponsor
Universidad de Monterrey
Collaborators
FEMSA Foundation, Mexican Food Banks
Responsible party
Sponsor
First posted
Sep 26, 2016
Start date
Jun 2016
Primary completion
Dec 19, 2017
Completion
Mar 1, 2018
Last update
May 3, 2018

Study contacts

Ana Carla Cepeda-Lopez, PhD
principal investigator · Universidad de Monterrey

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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