Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-28 @ 8:46 PM
Study NCT ID:
NCT05191303
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2021-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Mobile Intervention for Breast Feeding Counseling (MIBFc) in Primiparous Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Statistician, who is not involved in the study has done block-randomization with variable block-sizes (2,4,6) by StatsDirect program for two groups; an intervention and control group. Maternity care staff asks informed consent and then performs the randomization of primiparous women to the intervention or control group.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single-blind randomized controlled trial with a two-arm design will be conducted among primiparous mothers. Participants are randomized to two groups, a intervention and a control group. Participants receive standard usual care of breastfeeding counselling in both groups. In addition, the intervention group members will use mobile intervention of breastfeeding counseling.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exclusive breastfeeding relative rate at 1 months of age', 'timeFrame': '1 month after childbirth', 'description': 'Proportion of infants exclusive breastfeeding at 1 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.'}, {'measure': 'Exclusive breastfeeding relative rate at 4 months of age', 'timeFrame': '4 moths after childbirth', 'description': 'Proportion of infants exclusive breastfeeding at 4 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.'}, {'measure': 'Exclusive breastfeeding relative rate at 6 months of age', 'timeFrame': '6 months after childbirth', 'description': 'Proportion of infants exclusive breastfeeding at 6 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.'}], 'secondaryOutcomes': [{'measure': 'The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancy', 'timeFrame': 'Measurements are made in 18 and 34 weeks of gestation', 'description': 'IIFAS is a 17-items scale developed by De la Mora and Russell (1999) to evaluate maternal attitudes toward infant feeding. The Scale relatively easy to administer and score and it is usable with a wide variety of populations. Scale is 5 point Likert type scale.'}, {'measure': 'Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)', 'timeFrame': 'Measurements are made in 1 and 4 months after childbirth', 'description': 'Breastfeeding Self-Efficacy Scale-Short Form: It is a 33-item scale developed by Dennis and Faux (1999) to evaluate breastfeeding self-efficacy levels of mothers. Later, a 14-item short form of the scale was developed in 2003 (Dennis 2003). Dennis (2003) recommends this short form for use. It is applied more easily and evaluates self-efficacy correctly. Breastfeeding Self-Efficacy Short Form Scale is a 5 point Likert type scale.'}, {'measure': 'Satisfaction of breastfeeding guidance', 'timeFrame': 'Measurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.', 'description': 'Satisfaction of breastfeeding guidance measured with Visual Analogue Scale (VAS) (numeric 0 to 10)'}, {'measure': 'Use of infants additional milk at hospital after childbirth', 'timeFrame': 'The researcher retrieves the data from the patient record after 6 months of childbirth.', 'description': 'Use of infants additional milk at hospital after childbirth and only medical supplementary milk accepted'}, {'measure': 'Infants exclusive breastfeeding rate (relative share / portion)', 'timeFrame': 'The researcher retrieves the data from the patient record after 6 months of childbirth.', 'description': 'Infants exclusive breastfeeding rate (relative share / portion) when leaving the hospital. Only medical supplementary milk accepted'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile application', 'Attitude', 'Confidence, Self', 'Counseling', 'Intervention', 'Randomized controlled trial (RCT)', 'Breast Feeding, exclusive', 'Primiparous'], 'conditions': ['Breast Feeding, Exclusive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of mobile intervention for breastfeeding counseling (MIBFc) to improve exclusive breastfeeding duration among primiparous women in Finland.', 'detailedDescription': 'The investigators hypothesize that the use of mobile intervention for breastfeeding counseling to primiparous women improve the exclusive breastfeeding rates, breastfeeding attitudes, breastfeeding confidence and the satisfaction of breastfeeding counselling. These outcomes are assumed to be higher in the intervention group than in the control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primiparous women\n* 18 years or older\n* finnish language\n* singleton foetus\n* have an intention to breastfeed\n* have a smartphone\n\nExclusion Criteria:\n\n* multiple pregnancy\n* risk pregnancy, or other disease to be monitored'}, 'identificationModule': {'nctId': 'NCT05191303', 'briefTitle': 'Effectiveness of Mobile Intervention for Breast Feeding Counseling (MIBFc) in Primiparous Mothers', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Developing Mobile Intervention of the Breast Feeding Counseling and Evaluating Its Effectiveness in Primiparous Mothers', 'orgStudyIdInfo': {'id': '1954032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'In addition to standard usual care of breastfeeding counseling, the intervention group will have an opportunity to access the mobile application breastfeeding counseling from weeks 18 of pregnancy, continuing for up to 6 months after childbirth.', 'interventionNames': ['Device: Mobile intervention of breastfeeding counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group receives the standard usual care of breastfeeding counseling in maternity care and in hospital from weeks 18 of pregnancy, continuing for up to 6 months after childbirth.\n\nThe standard usual care of breastfeeding follows the 10 steps of the Baby Friendly Hospital Initiative programme and Finnish Institute for Health and Welfare recommendation.'}], 'interventions': [{'name': 'Mobile intervention of breastfeeding counseling', 'type': 'DEVICE', 'description': 'The mobile intervention of breastfeeding counseling includes an evidence-based information of breastfeeding, which is based on Ten steps of breastfeeding of Baby Friendly Hospital Initiative (BFHI) and Finnish Institute for Health and Welfare recommendation. The links provide more information and videos related to breastfeeding topic. The mobile intervention of breastfeeding counseling allows the client to write comments or notes that can be used in counseling at maternity clinic or hospital. The mobile intervention of breastfeeding counseling also provides an e-mail to non-urgent questions related to breastfeeding. Questions will be answered within 3 or 4 days by a lactation consultant (IBCLC).', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90580', 'city': 'Oulu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Pirkko Nikula', 'role': 'CONTACT', 'email': 'pirkko.nikula@oulu.fi', 'phone': '+358 405145342'}, {'name': 'Tarja Pölkki', 'role': 'CONTACT', 'email': 'tarja.polkki@oulu.fi', 'phone': '+358 504280772'}], 'facility': 'City of Oulu Maternity Clinic', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'centralContacts': [{'name': 'Pirkko Nikula', 'role': 'CONTACT', 'email': 'pirkko.nikula@oulu.fi', 'phone': '+358 405145342'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oulu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pirkko Nikula', 'investigatorAffiliation': 'University of Oulu'}}}}