ClinicalTrials.gg
CompletedNCT02258802Updated May 13, 2016

Pilot 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. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-05-13.

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

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Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

The purpose of this study is to develop, implement and evaluate a psychoeducational intervention focused to improve nutritional status, specifically micronutrients, of mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities.

Read the detailed description

Mexico's malnutrition problem goes beyond lack of food. Nutrition transition in our country has modified dietary patterns in a way that now we observe more and more a decrease in consumption of micronutrient rich foods, like vegetables, and an increase in consumption of high energy-dense foods with low content of micronutrients (highly processed foods). In Mexico, over 70% of the population presents an inadequate vegetable intake, with a higher prevalence in scholars (5 - 11 years), where only 17% of them consume >50% of the recommended vegetable intake. A vegetable poor diet is related to malnutrition, poor cognitive development and low physical performance. Added to this, Mexican families have lost the tradition of cooking at home. It is well known that different factors contribute to a population's diet and cooking at home as well as eating with the family have been identified as fundamental factors to promote a healthy diet. Therefore, the aim of this psychoeducational intervention in nutrition is 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.

02

Conditions studied

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

Keywords

  • psychoeducational intervention
  • nutrition intervention
  • malnutrition
  • micronutrient deficiency
  • nutrition transition
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 65 is below 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 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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 60 years
  • Premenopausal
  • \< 45 during enrollment
  • Apparently healthy
  • With a child in her care between the ages of 5 and 13 years

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 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

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

Interventions

  • BehavioralPsychoeducational intervention

    A mobile kitchen visits the 5 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. A printed version of the recipe is given to every participant. Every lesson a different participant is encouraged to help 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 behaviour

    questionnaire

    Time frame: baseline, 6 months, 1 year

Secondary outcomes

  1. Change in vegetable intake

    24 hour recall

    Time frame: baseline, 1 year

  2. Change in dietary practices

    questionnaire

    Time frame: baseline, 6 months, 1 year

  3. Change in food waste

    questionnaire

    Time frame: baseline, 6 months, 1 year

  4. Change in cognitive development in children

    questionnaire

    Time frame: baseline, 1 year

  5. Change in anthropometry

    weight, height and waist circumference

    Time frame: baseline, 6 months, 1 year

  6. Change in micronutrient status

    serum sample

    Time frame: baseline, 1 year

  7. Change in inflammatory markers

    serum sample

    Time frame: baseline, 1 year

07

Study locations

No study locations are listed for this record.

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
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Jul 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

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

Registered
Sep 30, 2014
First posted
Oct 7, 2014
Start
Jun 2014
Primary completionActual
Jul 2015
CompletionActual
Dec 2015
Last update
May 13, 2016
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 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02258802
Lead sponsor
Universidad de Monterrey
Collaborators
FEMSA Foundation
Responsible party
Sponsor
First posted
Oct 7, 2014
Start date
Jun 2014
Primary completion
Jul 2015
Completion
Dec 2015
Last update
May 13, 2016

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 May 2016. You cannot join it, but the record below documents what was studied.

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