Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-02 @ 2:44 AM
Study NCT ID:
NCT04708769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elements Vital to Treat Obesity Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 524}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline to 6-Months', 'description': 'Participant change in weight, in kilograms, from baseline to 6-months.'}], 'secondaryOutcomes': [{'measure': 'Costs of treatment', 'timeFrame': '12 Months', 'description': 'Costs of EVO versus DPP implementation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight Loss', 'Diet', 'Physical Activity', 'Self Monitoring', 'Mobile Health'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '38375882', 'type': 'DERIVED', 'citation': 'Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.', 'detailedDescription': 'The proposed study seeks to determine if the APP program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the DPP program. During the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) APP, wherein participants receive calorie, fat, and physical activity goals via a Smartphone application for self-monitoring, online educational readings, and biweekly sessions with a Health Promotionist; or 2) DPP, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a Health Promotionist. Assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 30-45\n* Weight stable\n* Own a Smartphone and be willing to install our Smartphone app\n* Willing to conduct video conference calls with study staff\n\nExclusion Criteria:\n\n* Enrolled in any formal weight loss program\n* Taking anti-obesity medications\n* Not taking medications that may cause weight gain\n* Unstable medical conditions\n* Diabetes requiring insulin supplementation\n* Crohn's Disease\n* Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)\n* Assistive devices for mobility\n* Hospitalizations for a psychiatric disorder within the past 5 years\n* Cardiovascular disease symptoms while performing moderate intensity exercise\n* Pregnancy, trying to get pregnant, or lactating.\n* Bulimia or binge eating disorder\n* Reports of active suicidal ideation\n* Current substance abuse or dependence besides nicotine dependence"}, 'identificationModule': {'nctId': 'NCT04708769', 'acronym': 'EVO', 'briefTitle': 'Elements Vital to Treat Obesity Study', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.', 'orgStudyIdInfo': {'id': 'STU00212742'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartphone App Participants (APP)', 'description': 'Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist', 'interventionNames': ['Behavioral: Smartphone App Participants (APP)']}, {'type': 'EXPERIMENTAL', 'label': 'Diabetes Prevention Program Participants (DPP)', 'description': 'Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist', 'interventionNames': ['Behavioral: Diabetes Prevention Program Participants (DPP)']}], 'interventions': [{'name': 'Smartphone App Participants (APP)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.', 'armGroupLabels': ['Smartphone App Participants (APP)']}, {'name': 'Diabetes Prevention Program Participants (DPP)', 'type': 'BEHAVIORAL', 'description': 'In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.', 'armGroupLabels': ['Diabetes Prevention Program Participants (DPP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Angela Pfammatter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Angela Fidler Pfammatter, PhD', 'investigatorAffiliation': 'Northwestern University'}}}}