Child MalnutritionNCT02914002
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 at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- 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
- 12,400 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2016to 1 Mar 2018
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding
- With a hysterectomy in the past 3 months
- Alcohol consumption > 14 drinks a week
- Use of vitamin supplements
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Child Malnutrition, Child Overnutrition, Malnutrition in Children, Malnutrition, Child, Nutrition Disorders, Child, Malnutrition
- Being tested
- Psychoeducational intervention
- 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 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.
| 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 - 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food knowledge and behavior Questionnaire
Measured: Baseline, 1 year
Change in Weight
Measured: Baseline, 1 year
Change in height
Measured: Baseline, 1 year
Change in psychosocial risk Questionnaire
Measured: Baseline, 1 year
Secondary outcomes (2)
Change in capillary hemoglobin
Capillary blood sample
Measured: Baseline, 1 year
Change in capillary glucose
Capillary blood 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 posted26 Sep 2016 (estimated)
- Study startJun 2016
- Primary completion19 Dec 2017
- Study completion1 Mar 2018
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
- 12,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Monterrey
- Sponsor type
- University, hospital or other
- Collaborators
- FEMSA Foundation, Mexican Food Banks
- Responsible party
- Sponsor
- Investigators
- Ana Carla Cepeda-Lopez, PhD, Principal investigator, Universidad de Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914002
- Sponsor's protocol ID
- 502016-CIE
- Status last verified
- Apr 2018
- First submitted
- 22 Sep 2016
- Last updated
- 3 May 2018
- 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 3 May 2018. 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 15 Low Resource Populations Through a Network of Food Banks in Mexico.
- ClinicalTrials.gov ID
- NCT02914002
- Acronym / sponsor ID
- 502016-CIE
- Conditions
- Child Malnutrition, Child Overnutrition, Malnutrition in Children, Malnutrition, Child, Nutrition Disorders, Child, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,400 participants (actual)
- Lead sponsor
- Universidad de MonterreyUniversity, hospital or other
- Collaborators
- FEMSA Foundation, Mexican Food Banks
- Study start
- Jun 2016 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 26 Sep 2016 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| 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 - 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
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 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. | Behavioural | Psychoeducational intervention |
Primary outcome
Change in food knowledge and behavior Questionnaire
Time frame: Baseline, 1 year
Change in Weight
Time frame: Baseline, 1 year
Change in height
Time frame: Baseline, 1 year
Change in psychosocial risk Questionnaire
Time frame: Baseline, 1 year
2 secondary outcomes
Change in capillary hemoglobin
Time frame: Baseline, 1 year
Change in capillary glucose
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 3 May 2018.
- 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
1 site in 1 country: see every site and its status.
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 at 1 site in Mexico.
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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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 behavior Questionnaire (time frame: Baseline, 1 year). The study lists 4 primary outcomes in all. 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 3 May 2018.