Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:15 AM
Study NCT ID:
NCT07443995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evidence-based Intervention for Diabetes Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Weight loss', 'timeFrame': '0 and 3 months', 'description': 'Mean weight loss at 3 months post baseline.'}], 'primaryOutcomes': [{'measure': 'Intervention acceptability based on the proportion of sessions attended', 'timeFrame': '3 months (post intervention)', 'description': 'Acceptability of the intervention will be measured by the number (%) of intervention sessions attended. Each participant will be offered 12 intervention sessions, and the acceptability of the intervention will be measured by the proportion of sessions attended (# sessions attended/ 12).'}], 'secondaryOutcomes': [{'measure': 'Changes in glycemia', 'timeFrame': '0 and 3 months', 'description': 'Changes in HbA1c at 3 months post baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-diabetes', 'behavioral intervention', 'diet', 'physical activity'], 'conditions': ['Pre-diabetes', 'Lifestyle Risk Reduction', 'Diet Prevention of Metabolic Diseases']}, 'descriptionModule': {'briefSummary': 'The goal of this behavioral intervention trial is to develop strategies to decrease the incidence of diabetes within the UAE. The investigators will investigate the effectiveness of a group-based telehealth intervention facilitated by a health coach in adults at risk for developing diabetes who live in the UAE.\n\nThe investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English.\n\nThe primary feasibility measure is acceptability, as measured by intervention session attendance. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi, where study staff will assess weight, hemoglobin A1c, diet, and physical activity.', 'detailedDescription': 'Study Purpose This feasibility study will investigate the effectiveness of an individual automated plus group-based telehealth arm facilitated by a health coach. The long-term goal is to develop strategies to decrease the incidence of diabetes within the UAE.\n\nStudy Hypotheses Participants will attend \\>50% of intervention sessions and will experience a clinically significant reduction in weight of 3.5% after 12 weeks. Predictors of intervention acceptability will include age, gender, and baseline body mass index.\n\nStudy Objectives Study investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English.\n\nThe primary feasibility measure is acceptability. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi where study staff will assess weight, hemoglobin A1c, diet, and physical activity.\n\nThis project will accomplish the following specific aims:\n\nAim 1: Identify predictors associated with intervention adherence.\n\nPredictors of adherence to intervention arms will include age, gender, and baseline body mass index.\n\nPredictors of adherence to intervention arms will include age, gender, and baseline body mass index. Investigators will also evaluate the acceptability of the intervention using surveys and semi-structured interviews.\n\nAim 2: Assess the effectiveness of the intervention on key clinical outcomes.\n\nHypothesis 2: Participants will experience a clinically significant reduction in weight of 3.5% after 12 weeks. In-person outcome assessment visits to measure weight and glycemia at baseline, and 3 months among all participants will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18 years or older\n* Diabetes risk score \\> 5\n* BMI \\>=25kg/m\\^2\n* Arabic or English speaking\n* Able to read and write in Arabic or English\n* Access to a smartphone\n* Provide informed consent\n\nExclusion Criteria:\n\n* Prevalent diabetes\n* Prior participation in a diabetes prevention program\n* Taking FDA-approved weight loss medications\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT07443995', 'acronym': 'EID', 'briefTitle': 'Evidence-based Intervention for Diabetes Prevention', 'organization': {'class': 'OTHER', 'fullName': 'New York University'}, 'officialTitle': 'Evidence-based Intervention for Diabetes Prevention', 'orgStudyIdInfo': {'id': 'ADHRTC-2025-195/HRPP-2023-238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group facilitated behavioral counseling arm', 'description': 'Participants in this arm will participate in 12 group counseling sessions online. Sessions will be weekly. The 12 sessions are adapted from the CDC DPP program and will deliver culturally appropriate information on diet and activity to prevent diabetes. The participants will have access to video content and will also receive written curricular materials. All materials are culturally adapted and translated into Arabic. The participants will also have access to a local smartphone app to assist with goal setting, logging physical activity and food intake, as well as receiving additional personalized health recommendations.', 'interventionNames': ['Behavioral: Adapted diabetes prevention program', 'Behavioral: App based support', 'Behavioral: Patient education materials']}], 'interventions': [{'name': 'Adapted diabetes prevention program', 'type': 'BEHAVIORAL', 'description': 'The intervention is based on the CDC Diabetes Prevention Program and has been adapted into a culturally appropriate intervention in an Arab context. The program has been condensed into 12 sessions with an additional session that addresses lifestyle factors during Ramadan. Each session covers a different topic related to diet, physical activity, sleep, and stress management. Additionally, the intervention includes written materials to help participants develop lifestyle goals and encourages them to seek social support. There are a series of 12 videos in Arabic and English that support the information delivered in the group sessions.\n\nIn addition to the group sessions, participants will have access to the automated app and education materials.', 'armGroupLabels': ['Group facilitated behavioral counseling arm']}, {'name': 'App based support', 'type': 'BEHAVIORAL', 'description': 'This intervention will provide educational videos that have been culturally adapted to the Arab context and additional automated supports for lifestyle modification. Study participants will be provided with access to an app that they will be encouraged to engage with on a regular basis. The app will provide basic diet, physical activity, and lifestyle support to prevent diabetes. Participants will also be able to track activity, diet, and receive feedback on their personal weight, diet habits, and activity levels.', 'armGroupLabels': ['Group facilitated behavioral counseling arm']}, {'name': 'Patient education materials', 'type': 'BEHAVIORAL', 'description': 'Participants will be provided written or web-based diabetes prevention materials. These materials will provide basic tips on diet, physical activity and other lifestyle factors.', 'armGroupLabels': ['Group facilitated behavioral counseling arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '129188', 'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Andrea L Leinberger-Jabari, MPH', 'role': 'CONTACT', 'email': 'aj100@nyu.edu', 'phone': '971 2 628 4206'}, {'name': 'Youssef Idaghdour, PhD', 'role': 'CONTACT', 'email': 'yi3@nyu.edu', 'phone': '971 2 628 5332'}, {'name': 'Youssef Idaghdour, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University Abu Dhabi', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Jeannette Beasley, PhD', 'role': 'CONTACT', 'email': 'jbeasley@nyu.edu', 'phone': '646-501-4681'}], 'overallOfficials': [{'name': 'Jeannette Beasley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Local data privacy laws may prohibit the public sharing of individual-level participant data. We will share data upon a reasonable request to the study PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}