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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02914002
Date of registration: 22/09/2016
Prospective Registration: No
Primary sponsor: Universidad de Monterrey
Public title: Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings
Scientific title: A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in 15 Low Resource Populations Through a Network of Food Banks in Mexico.
Date of first enrolment: June 2016
Target sample size: 12400
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02914002
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Mexico
Contacts
Name:     Ana Carla Cepeda-Lopez, PhD
Address: 
Telephone:
Email:
Affiliation:  Universidad de Monterrey
Key inclusion & exclusion criteria

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:

- Pregnant or breastfeeding

- With a hysterectomy in the past 3 months

- Alcohol consumption > 14 drinks a week

- Use of vitamin supplements



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Nutrition Disorders, Child
Child Overnutrition
Malnutrition, Child
Malnutrition in Children
Child Malnutrition
Malnutrition
Intervention(s)
Behavioral: Psychoeducational intervention
Primary Outcome(s)
Change in Weight [Time Frame: Baseline, 1 year]
Change in food knowledge and behavior Questionnaire [Time Frame: Baseline, 1 year]
Change in height [Time Frame: Baseline, 1 year]
Change in psychosocial risk Questionnaire [Time Frame: Baseline, 1 year]
Secondary Outcome(s)
Change in capillary hemoglobin [Time Frame: Baseline, 1 year]
Change in capillary glucose [Time Frame: Baseline, 1 year]
Secondary ID(s)
502016-CIE
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
FEMSA Foundation
Mexican Food Banks
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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