Child MalnutritionNCT02258802
Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings
A study testing Psychoeducational intervention in people with Child Malnutrition and Child Overnutrition, run by Universidad de Monterrey.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Child Malnutrition, Child Overnutrition, Malnutrition in Children
- What is being tested?
- Psychoeducational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Premenopausal
- BMI < 45 during enrollment
- Apparently healthy
- With a child in her care between the ages of 5 and 13 years
Who cannot join
- Pregnant or breastfeeding
- With a hysterectomy in the past 3 months
- Alcohol consumption > 14 drinks a week
- Use of vitamin supplements
About this study
Official title: A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in a Pilot Low Resource Population in the City of Saltillo, Coahuila Mexico.
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.
- Conditions
- Child Malnutrition, Child Overnutrition, Malnutrition in Children, Malnutrition, Child, Nutrition Disorders, Child, Malnutrition
- Being tested
- Psychoeducational intervention
- Keywords
- psychoeducational intervention, nutrition intervention, malnutrition, micronutrient deficiency, nutrition transition
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational interventionBehavioural
Also called Psychoeducational intervention in nutrition
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational intervention | Experimental | Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year. Receives: Behavioral: Psychoeducational intervention |
| Usual food practices | No intervention | These are participants from the communities where the intervention is active but are not attending the cooking lessons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food knowledge and behaviour
questionnaire
Measured: baseline, 6 months, 1 year
Secondary outcomes (7)
Change in vegetable intake
24 hour recall
Measured: baseline, 1 year
Change in dietary practices
questionnaire
Measured: baseline, 6 months, 1 year
Change in food waste
questionnaire
Measured: baseline, 6 months, 1 year
Change in cognitive development in children
questionnaire
Measured: baseline, 1 year
Change in anthropometry
weight, height and waist circumference
Measured: baseline, 6 months, 1 year
Change in micronutrient status
serum sample
Measured: baseline, 1 year
Change in inflammatory markers
serum sample
Measured: baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Monterrey
- Sponsor type
- University, hospital or other
- Collaborators
- FEMSA Foundation
- Responsible party
- Sponsor
- Investigators
- Ana Carla Cepeda-Lopez, PhD, Principal investigator, Universidad de Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258802
- Sponsor's protocol ID
- 102014-CIE
- Status last verified
- May 2016
- First submitted
- 30 Sep 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in a Pilot Low Resource Population in the City of Saltillo, Coahuila Mexico.
- ClinicalTrials.gov ID
- NCT02258802
- Acronym / sponsor ID
- 102014-CIE
- Conditions
- Child Malnutrition, Child Overnutrition, Malnutrition in Children, Malnutrition, Child, Nutrition Disorders, Child, Malnutrition
- Keywords
- psychoeducational intervention, nutrition intervention, malnutrition, micronutrient deficiency, nutrition transition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universidad de MonterreyUniversity, hospital or other
- Collaborators
- FEMSA Foundation
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational intervention | Experimental | Behavioral: Psychoeducational interventionParticipants will be receiving a cooking lesson in their community every 2 weeks for 1 year. |
| Usual food practices | No intervention | –These are participants from the communities where the intervention is active but are not attending the cooking lessons. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 60 years
- Premenopausal
- BMI < 45 during enrollment
- Apparently healthy
- With a child in her care between the ages of 5 and 13 years
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- With a hysterectomy in the past 3 months
- Alcohol consumption > 14 drinks a week
- Use of vitamin supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational interventionAlso: Psychoeducational intervention in nutritionA 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. | Behavioural | Psychoeducational intervention |
Primary outcome
Change in food knowledge and behaviour
Time frame: baseline, 6 months, 1 year
questionnaire
7 secondary outcomes
Change in vegetable intake
Time frame: baseline, 1 year
Change in dietary practices
Time frame: baseline, 6 months, 1 year
Change in food waste
Time frame: baseline, 6 months, 1 year
Change in cognitive development in children
Time frame: baseline, 1 year
Change in anthropometry
Time frame: baseline, 6 months, 1 year
Change in micronutrient status
Time frame: baseline, 1 year
Change in inflammatory markers
Time frame: baseline, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Carla Cepeda-Lopez, PhD principal investigator
Universidad de Monterrey
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational intervention in people with Child Malnutrition and Child Overnutrition, run by Universidad de Monterrey.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in food knowledge and behaviour (time frame: baseline, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.