Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT03784612
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2018-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Healthy Eating with APP TechnologY Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in dietary intake and eating habits', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using a 94 item food frequency questionnaire (FFQ)'}, {'measure': 'Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21)', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using a 21-item questionnaire'}, {'measure': 'Change in physical activity assessed using the Active-Q questionnaire', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using a 48 item questionnaire including activities in domains of Daily occupation, transportation, leisure time, and exercise'}, {'measure': 'Change in self-reported medication use', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'One question on medication use for blood sugar levels and one questions on medication use for blood lipid levels'}, {'measure': 'Change in tobacco use habits', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Two questions regarding smoking and Swedish snuff use'}, {'measure': 'Change in sleeping habits', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using a modified 13-item Karolinska Sleep questionnaire'}, {'measure': 'Change in perceived purpose in Life (PIL)', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using 6-item questionnaire'}, {'measure': 'Change in perceived stress levels', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using the 14-item perceived stress scale (PSS)'}, {'measure': 'Change in self-reported diabetes self-efficacy', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using a 20-item questionnaire'}, {'measure': 'Change in health related quality of life', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using the 36-item RAND-36 questionnaire'}, {'measure': 'Change in perceived social support from family and friends for healthy eating habits', 'timeFrame': 'Baseline and month 3, 6 and 12', 'description': 'Assessed using a 3-item questionnaire'}], 'primaryOutcomes': [{'measure': 'Change in dietary intake', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'Change in dietary intake assessed using a four day food record.'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'mmol/mol, Heamoglobin A1c'}, {'measure': 'Total cholesterol', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'mmol/L'}, {'measure': 'HDL-cholesterol', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'mmol/L'}, {'measure': 'Triglycerides', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'mmol/L'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'kg/m2, measured height and weight'}, {'measure': 'Body weight', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'kg, measured'}, {'measure': 'Body composition: Body fat', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'Body fat (kg), measured using a bioelectrical scale'}, {'measure': 'Body composition: Fat free mass', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'Fat free mass (kg), measured using a bioelectrical scale'}, {'measure': 'Body composition: Muscle mass', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'Muscle mass (kg), measured using a bioelectrical scale'}, {'measure': 'Body composition: Total body water', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'Total body water (kg), measured using a bioelectrical scale'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'cm, measured'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and month 3, and 6', 'description': 'mmHg, measured'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartphone application', 'HbA1c', 'Blood lipids', 'Dietary intake'], 'conditions': ['Type 2 Diabetes Mellitus', 'Dietary Habits']}, 'referencesModule': {'references': [{'pmid': '40510749', 'type': 'DERIVED', 'citation': 'Cecchini V, Sjoblom L, Lagerros YT, Bonn SE. The Effect of a Mobile Health Dietary Education Intervention on Ultra-processed Food Consumption in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Curr Dev Nutr. 2025 Apr 28;9(6):107454. doi: 10.1016/j.cdnut.2025.107454. eCollection 2025 Jun.'}, {'pmid': '39754157', 'type': 'DERIVED', 'citation': 'Sjoblom L, Hantikainen E, Dahlgren A, Trolle Lagerros Y, Bonn SE. The effect of an app-based dietary education on dietary intake and cardiometabolic risk markers in people with type 2 diabetes: results from a randomized controlled trial. Nutr J. 2025 Jan 4;24(1):2. doi: 10.1186/s12937-024-01069-2.'}, {'pmid': '37821876', 'type': 'DERIVED', 'citation': 'Pitt S, Sjoblom L, Balter K, Trolle Lagerros Y, Bonn SE. The effect of an app-based dietary intervention on diet-related greenhouse gas emissions - results from a randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Oct 11;20(1):123. doi: 10.1186/s12966-023-01523-0.'}, {'pmid': '33196448', 'type': 'DERIVED', 'citation': 'Trolle Lagerros Y, Dahlgren A, Sjoblom L, Bonn SE. Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial). JMIR Res Protoc. 2020 Nov 16;9(11):e24422. doi: 10.2196/24422.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of using new app-based technology to improve dietary habits, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology an an app-based course for healthy eating habits, will have a greater positive effect on dietary habits and biological markers, including HbA1c and serum lipids, than usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of type 2 diabetes\n* 18 years of age or older\n* Ability to communicate in Swedish\n* Own and use a smartphone with a personal digital ID\n\nExclusion criteria:\n\n\\- No specific exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT03784612', 'acronym': 'HAPPY', 'briefTitle': 'The Healthy Eating with APP TechnologY Study', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'The HAPPY-study: Digital Support for Healthier Eating Habits in Patients with Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care', 'orgStudyIdInfo': {'id': 'Dnr: 2018/652-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'App-technology group', 'description': 'Participants in the App-technology group arm will use a newly developed smartphone application ("app"), containing a 12-week healthy eating program.\n\nIntervention: App-technology for healthy eating habits.', 'interventionNames': ['Behavioral: App-technology for healthy eating habits']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will receive standard care.'}], 'interventions': [{'name': 'App-technology for healthy eating habits', 'type': 'BEHAVIORAL', 'description': 'Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.', 'armGroupLabels': ['App-technology group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Stephanie E Bonn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Assistant professor', 'investigatorFullName': 'Stephanie Bonn', 'investigatorAffiliation': 'Karolinska Institutet'}}}}