Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT02258802
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2014-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2014-09-30', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in food knowledge and behaviour', 'timeFrame': 'baseline, 6 months, 1 year', 'description': 'questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change in vegetable intake', 'timeFrame': 'baseline, 1 year', 'description': '24 hour recall'}, {'measure': 'Change in dietary practices', 'timeFrame': 'baseline, 6 months, 1 year', 'description': 'questionnaire'}, {'measure': 'Change in food waste', 'timeFrame': 'baseline, 6 months, 1 year', 'description': 'questionnaire'}, {'measure': 'Change in cognitive development in children', 'timeFrame': 'baseline, 1 year', 'description': 'questionnaire'}, {'measure': 'Change in anthropometry', 'timeFrame': 'baseline, 6 months, 1 year', 'description': 'weight, height and waist circumference'}, {'measure': 'Change in micronutrient status', 'timeFrame': 'baseline, 1 year', 'description': 'serum sample'}, {'measure': 'Change in inflammatory markers', 'timeFrame': 'baseline, 1 year', 'description': 'serum sample'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psychoeducational intervention', 'nutrition intervention', 'malnutrition', 'micronutrient deficiency', 'nutrition transition'], 'conditions': ['Child Malnutrition', 'Child Overnutrition', 'Malnutrition in Children', 'Malnutrition, Child', 'Nutrition Disorders, Child', 'Malnutrition']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 60 years\n* Premenopausal\n* BMI \\< 45 during enrollment\n* Apparently healthy\n* With a child in her care between the ages of 5 and 13 years\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* With a hysterectomy in the past 3 months\n* Alcohol consumption \\> 14 drinks a week\n* Use of vitamin supplements'}, 'identificationModule': {'nctId': 'NCT02258802', 'briefTitle': 'Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Monterrey'}, 'officialTitle': 'A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in a Pilot Low Resource Population in the City of Saltillo, Coahuila Mexico.', 'orgStudyIdInfo': {'id': '102014-CIE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychoeducational intervention', 'description': 'Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.', 'interventionNames': ['Behavioral: Psychoeducational intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual food practices', 'description': 'These are participants from the communities where the intervention is active but are not attending the cooking lessons.'}], 'interventions': [{'name': 'Psychoeducational intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Psychoeducational intervention in nutrition'], 'description': '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.', 'armGroupLabels': ['Psychoeducational intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ana Carla Cepeda-Lopez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Monterrey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Monterrey', 'class': 'OTHER'}, 'collaborators': [{'name': 'FEMSA Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}