Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-19 @ 10:00 AM
Study NCT ID:
NCT01813903
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2013-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Welfare Pilot Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-05', 'studyFirstSubmitDate': '2013-03-12', 'studyFirstSubmitQcDate': '2013-03-14', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food consumption of the parents', 'timeFrame': '7 months', 'description': 'Measured with Food Frequency Questionnaire'}, {'measure': 'Maternal post-natal depression', 'timeFrame': '9 months', 'description': 'Measured with Edinburgh Postnatal Depression Scale (EDPS)'}], 'secondaryOutcomes': [{'measure': "Food and health related attitudes and aims of the parent's", 'timeFrame': '9 months', 'description': 'Questions about food and health related attitudes and aims'}, {'measure': "Psychological flexibility of the parent's", 'timeFrame': '9 months', 'description': 'Measured with Acceptance \\& Action Questionnaire (AAQ-2)'}, {'measure': "Mental health of the parent's", 'timeFrame': '9 months', 'description': 'Measured with Mental Health Continuum Short Form (MHC-SF)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to test internet and mobile-based applications to support motivating lifestyle counseling to promote healthy eating habits of the mothers and their spouses expecting first child. The feasibility of the intervention will be evaluated in the pilot.', 'detailedDescription': "Lifestyle habits during pregnancy have long-term effects of baby's as well as mother's health. Pregnancy period is a favorable time for lifestyle changes, as the parents usually have motivation and assets to change lifestyle. Maternity welfare clinic is the place to promote healthy lifestyles because most Finnish families expecting child visit there at regular intervals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All families expecting their child at their standard 8-10 pregnancy weeks welfare clinic visit\n\nExclusion Criteria:\n\n* Parents are under 18-year-old\n* Parents do not speak Finnish\n* Parents do not have internet access'}, 'identificationModule': {'nctId': 'NCT01813903', 'acronym': 'HYPE', 'briefTitle': 'Family Welfare Pilot Intervention Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Institute for Health and Welfare'}, 'officialTitle': 'Family Welfare Pilot Intervention Study at Finnish Welfare Clinics', 'orgStudyIdInfo': {'id': 'THL10433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition', 'description': 'Intensified dietary counseling and use of web application.', 'interventionNames': ['Behavioral: Intensified dietary counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Flexible mind', 'description': 'Use of mobile applications.', 'interventionNames': ['Behavioral: Mobile application']}, {'type': 'NO_INTERVENTION', 'label': 'Normal maternity clinic visits', 'description': 'In control maternity clinics, nurses continue their usual counseling.'}], 'interventions': [{'name': 'Intensified dietary counseling', 'type': 'BEHAVIORAL', 'description': 'The intervention is completed by public health nurses who will be trained to provide family-centered empowering and motivational lifestyle counseling at the normal health check visit. Parents expecting child will use web application developed for nutritional counseling. Web application consists of dietary questionnaire from which the parents will receive immediately automatic feedback. Feedback concerns the quality of diet in relation to the Finnish nutrition recommendations. Feedback will be given in an encouraging format. Own targets of food changes can also be recorded in the application, and the application can be used to monitor how they are achieved.', 'armGroupLabels': ['Nutrition']}, {'name': 'Mobile application', 'type': 'BEHAVIORAL', 'description': 'Mothers expecting child will use mobile application. Mobile application consists of text, audio and video exercises, which are aimed to increase the psychological flexibility and thus mental and physical well-being.', 'armGroupLabels': ['Flexible mind']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01300', 'city': 'Vantaa', 'country': 'Finland', 'facility': 'Maternal welfare clinics', 'geoPoint': {'lat': 60.29414, 'lon': 25.04099}}], 'overallOfficials': [{'name': 'Suvi I Virtanen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Finnish Institute for Health and Welfare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'University of Helsinki', 'class': 'OTHER'}, {'name': 'University of Jyvaskyla', 'class': 'OTHER'}, {'name': 'VTT Technical Research Centre of Finland', 'class': 'OTHER'}, {'name': 'The Finnish Heart Association', 'class': 'UNKNOWN'}, {'name': 'The National Consumer Research Centre', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}