Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 11:43 AM
Study NCT ID:
NCT03781856
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
La Vida Buena Childhood Obesity Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'baseline to 6 months follow up', 'description': 'Weight and height measured at baseline, post intervention and 6 months.'}], 'secondaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': 'baseline to 6 months follow up', 'description': 'Increased physical activity as measured by the International Physical Activity Questionnaire - Short Form'}, {'measure': 'Fruit and vegetable consumption', 'timeFrame': 'baseline to 6 months follow up', 'description': 'As measured by self reported servings per day or week with higher values considered to be a better outcome'}, {'measure': 'Simple carbohydrate consumption', 'timeFrame': 'baseline to 6 months follow up', 'description': 'As measured by self report servings per day or week with lower values considered to be a better outcome'}, {'measure': 'Family healthy habits', 'timeFrame': 'baseline to 6 months follow up', 'description': 'As measured by the Family Nutrition and Physical Activity Tool designed to capture healthy family habits. The adapted scale includes 16 items that are score from 1 to 4 that measure physical activity, sport participation, television viewing and video games for their negative influence on child hood obesity. Total score ranges from 16 to 64 points, with an increased score being associated with positive outcomes. There is not threshold or cutoff for the scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['childhood obesity', 'intervention', 'community health workers', 'community-based'], 'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '31200685', 'type': 'DERIVED', 'citation': 'Tucker KM, Ingram M, Doubleday K, Piper R, Carvajal SC. La Vida Buena (The Good Life) evaluation: a quasi experimental intervention of a community health worker-led family-based childhood obesity program for Latino children 5-8 years of age on the US-Mexico border. BMC Public Health. 2019 Jun 14;19(1):759. doi: 10.1186/s12889-019-7081-x.'}]}, 'descriptionModule': {'briefSummary': 'Mariposa Community Health Center, a health center in Nogales, Arizona on the US-Mexico border, will provide a program to prevent obesity in children and create a community environment that supports a healthy lifestyle. Mariposa designed and implemented the La Vida Buena ("The Good Life") program and already know that helps families eat more healthily and exercise. Mariposa Community Health Center will test this program on younger children aged 5-8 years old. Providers will refer children who are overweight or obese to the La Vida Buena Program. In order to determine if the La Vida Buena program works, Mariposa Community Health center will implement the 8-week program with 100 overweight or obese children in their Nogales clinic. They will measure their weight (BMI), exercise levels and food habits at the beginning of the program and then 3- months and 6-months after the program ends. Mariposa will compare these results to children in the nearby Rio Rico clinic who do not receive the La Vida Buena program. These 100 overweight or obese children in Rio Rico will instead receive one educational session, and the same information will be collected regarding BMI, exercise level and food habits. After the 6-month period, the children from Rio Rico will be able to receive the full La Vida Buena program.', 'detailedDescription': "La Vida Buena is a Mariposa project to educate children and families about healthy eating and exercise habits. The Health providers at Mariposa Nogales and Rio Rico clinics will refer children between 5-8 years old who are overweight or obese and their parents. Each child must participate with a parent or adult caregiver who is at least 18 years old. Before the program begins, the participant will attend an informational consent/registration session where they will be asked to sign a consent form for themselves and their child if they want to participate. The study will ask for certain information from each participant in order to determine if the program is working. Each family will respond to a questionnaire at three points: at the beginning of the program, three months after beginning the program, and six months after beginning the program, for a total of six months.\n\nThe questionnaire will include questions about fruit, vegetable and carbohydrate consumption, family behavior and habits regarding eating and exercise, moderate and vigorous physical activity, sedentary behavior, local foods and environment factors that impact the family. In addition, the child's weight will be measured at each time point.\n\nParticipation in La Vida Buena will take 6 months. At the Nogales site, participants will be invited to a series of weekly classes over the course of 8 weeks that are being offered by the Mariposa clinic related to child healthy weight, exercise and nutrition. At the Rio Rico site, participants will be offered one face to face educational session about child healthy weight with Mariposa staff. Participants will be scheduled for BMI measurements and questionnaires three months after initiating the program, as well as six months after initiating the La Vida Buena Program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5 to 8 years of age\n* Above the 85th percentile for obesity\n* Accompanied by a parent or legal guardian.\n\nExclusion Criteria:\n\n* Not between the ages of 5 and 8\n* Not above the 85th percentile for obesity.\n* Not accompanied by a parent or legal guardian.'}, 'identificationModule': {'nctId': 'NCT03781856', 'briefTitle': 'La Vida Buena Childhood Obesity Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'La Vida Buena (The Good Life) Evaluation: A Quasi Experimental Intervention of a Community Health Worker Led Family-based Childhood Obesity Program for Hispanic Children 5-8 Years of Age on the US-Mexico Border', 'orgStudyIdInfo': {'id': '1710977008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'La Vida Buena Program', 'description': 'Administered in a group setting over the course of 8 weeks in a community setting.', 'interventionNames': ['Behavioral: La Vida Buena Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brief educational session', 'description': 'Administered one on one or in a group setting in a one-hour session at the clinic', 'interventionNames': ['Behavioral: Brief Educational Session']}], 'interventions': [{'name': 'La Vida Buena Program', 'type': 'BEHAVIORAL', 'description': 'The intervention is series of interactive one hour weekly classes over the course of 8 weeks related to child healthy weight, exercise and nutrition. Facilitated by community health workers, the classes are interactive and play-based and designed to engage both the child and accompanying parent or guardian in activities.', 'armGroupLabels': ['La Vida Buena Program']}, {'name': 'Brief Educational Session', 'type': 'BEHAVIORAL', 'description': 'A one hour session about nutrition and physical activity to address obesity facilitated by a community health worker', 'armGroupLabels': ['Brief educational session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85621', 'city': 'Nogales', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mariposa Community Health Center', 'geoPoint': {'lat': 31.34038, 'lon': -110.93425}}], 'overallOfficials': [{'name': 'Maia Ingram', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There is currently no plan in place, however in the future the data dictionaries and individual participant data will be available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mariposa Community Health Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}