Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 12:42 AM
Study NCT ID:
NCT06067451
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMART GOALS for Youth With Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001522', 'term': 'Behavior, Animal'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We\'ll enroll 60 pediatric subjects diagnosed with prediabetes within three months at the Pediatric Diabetes Clinic. These subjects will be randomly assigned to two arms. All participants will receive standardized medical nutrition therapy protocol and visit frequency from RD. Study group participants will get the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT). SGSG will outline three SMART goal domains (exercise, diet, behavior) with a primary goal and example goals. Participants will personalize 2-3 SMART goals, those in standard of care group will just be asked "what changes they plan to make".'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-09-15', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the impact of SMART Goal setting on BMI z-scores To determine the impact of SMART Goal setting on BMI z-scores', 'timeFrame': '6 months', 'description': 'To determine the impact of SMART Goal setting on BMI z-scores, will assess anthropometrics at baseline, month 3 and at final visit (month 6)'}], 'secondaryOutcomes': [{'measure': 'Temporal changes in Hemoglobin A1c between the study and control groups', 'timeFrame': '3 months', 'description': 'A1c will be drawn every 3 months.'}, {'measure': 'Temporal changes in Lipids', 'timeFrame': '6 months', 'description': 'Lipid panel to be drawn at baseline and again at 6 months if show elevation are detected per standard of care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition'], 'conditions': ['PreDiabetes', 'Adolescent Obesity', 'Behavior, Health', 'Nutritional and Metabolic Diseases', 'Diet Habit', 'Lifestyle Risk Reduction']}, 'referencesModule': {'references': [{'pmid': '32487284', 'type': 'BACKGROUND', 'citation': 'Hales CM, Carroll MD, Fryar CD, Ogden CL. 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Pediatric weight management interventions in primary care settings: A meta-analysis. Health Psychol. 2016 Jul;35(7):704-713. doi: 10.1037/hea0000381. Epub 2016 Apr 18.'}, {'pmid': '17351283', 'type': 'BACKGROUND', 'citation': 'Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.'}, {'pmid': '36385196', 'type': 'BACKGROUND', 'citation': 'Beals E, Deierlein A, Katzow M. Clinical interventions to increase vegetable intake in children. Curr Opin Pediatr. 2023 Feb 1;35(1):138-146. doi: 10.1097/MOP.0000000000001203. Epub 2022 Nov 17.'}, {'pmid': '22331335', 'type': 'BACKGROUND', 'citation': 'DeBar LL, Stevens VJ, Perrin N, Wu P, Pearson J, Yarborough BJ, Dickerson J, Lynch F. A primary care-based, multicomponent lifestyle intervention for overweight adolescent females. Pediatrics. 2012 Mar;129(3):e611-20. doi: 10.1542/peds.2011-0863. Epub 2012 Feb 13.'}, {'pmid': '23531463', 'type': 'BACKGROUND', 'citation': 'Tucker SJ, Ytterberg KL, Lenoch LM, Schmit TL, Mucha DI, Wooten JA, Lohse CM, Austin CM, Mongeon Wahlen KJ. Reducing pediatric overweight: nurse-delivered motivational interviewing in primary care. J Pediatr Nurs. 2013 Nov-Dec;28(6):536-47. doi: 10.1016/j.pedn.2013.02.031. Epub 2013 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the impact of a SMART ((specific, measurable, attainable, realistic, or timely) Goal setting protocol on body weight, metabolic parameters (Hemoglobin A1c, lipids), diet quality and physical activity frequency in obese children with prediabetes in the outpatient setting. The main question is if participants using the SMART Goal Setting Protocol (SGSP) will have a significant reduction. The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), in BMI Z-score, A1c, and dyslipidemia in 6 months compared to controls.', 'detailedDescription': "Implementing a SMART goal-setting protocol for the overweight and obese pediatric population with prediabetes can benefit patients by empowering participants to set their own goals. In addition, utilizing a standardized tool can provide a more focused approach to behavior change between visits and increase a child's sense of self- efficacy and autonomy which may enhance motivation and engagement in the treatment process. This study can add strength to current interventions involving childhood obesity and prediabetes management and may inform the development of a more effective interventions in this population. By providing evidenced-based strategies, this study has the potential to improve the health of children at risk for type 2 diabetes.\n\nThe investigators will recruit 60 participants with newly diagnosed prediabetes to the proposed study.\n\nParticipants will be recruited from the outpatient clinic of the Children's Diabetes Center at the Cohen Children's Medical Center, Long Island, NY.\n\nParticipants will be randomized in a 1:1 ratio to one of the two arms. The participants will be stratified by Tanner stage (II and III vs IV and V) and sex (Male vs Female) before randomization.\n\nThe Medical Nutrition therapy (MNT) Protocol and visit frequency will be the same for all of the study participants in both the study and standard of care group in which the Registered Dietician (RD) will reinforce and encourage healthy habits and behaviors In addition successes and barriers to change.\n\nAt the end of each visit, the participants in the standard of care (SOC) group will be asked to provide a summary of topics discussed and what the participants plan to improve on from now and their next visit: responses will be documented in the EMR, and participants will schedule a follow-up visit in 1-4 months.\n\nThe participant randomized in the study group will first receive the SGSG which will highlight 3 domains of SMART goals (exercise, diet, and behavior). Each domain will have 1 predetermined and unchanging primary goal which will serve as the standard for all participants to strive for based on the latest literature recommendations. In addition, each domain will provide a list of examples of SMART goals for participants to choose from. Participants will be asked to independently select and personalize 2-3 SMART goals from this list.\n\nThe Registered Dietitian will identify the patient's perceived challenges in achieving their goal, work collaboratively with the patient to problem-solve and make necessary modifications to the goal to overcome challenges. The provider may suggest scaling back the goal if participant reports that perceived challenges are deemed to be significant or participants may choose to work on new goals or will intensify current goals as necessary at the end of each follow-up. The goal will be recorded in the WGMT for progress evaluation and monitoring. This tool should be returned at follow-up. The WGMT will be documented into the patients' chart and scanned into the Electronic Medical Record (EMR).\n\nThe study will evaluate changes in weight throughout the intervention by measuring participants anthropometric parameters, including height, weight, and BMI. These measurements will be taken at baseline, 1-4 months, and 4-7 months using the Touchbase Electronic medical record system, which will calculate BMI based on CDC growth charts adjusted for age and sex based.\n\nTo assess changes in metabolic parameters, routine laboratory data will be collected based on the discretion of the attending endocrinologist per the standard of care. This will include Hemoglobin A1c, lipid panel and blood pressure. The data will be used to evaluate changes in metabolic health over the course of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Children between ages 10-18 years at baseline visit\n2. Children with BMI for age and sex ≥ 85th percentile at baseline visit\n3. Children with hemoglobin A1c 5.7% to 6.4% at baseline visit\n\nExclusion Criteria:\n\n1. Children who are not able to provide assent to the study\n2. Children less than 10 years in age\n3. Children that are not interested in weight loss or diet and lifestyle change\n4. Children with known diabetes that use medications that alter glucose or lipid metabolism such as (insulin, metformin, Glucagon Like Peptide-1 Receptor Antagonist (GLP-1 RA), Statins, Accutane).\n5. Children on medications that can alter body weight (including antidepressants, steroids, stimulants).\n6. Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder)\n7. Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis\n8. Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness\n9. Children with known or suspected eating disorders as identified through the electronic medical record\n10. Children that have known genetic or syndromic obesity\n11. Female children who are pregnant"}, 'identificationModule': {'nctId': 'NCT06067451', 'briefTitle': 'SMART GOALS for Youth With Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Impact of SMART GOAL Setting Protocol on Body Weight and Metabolic Parameters in Children and Adolescents With Prediabetes; a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '23-0375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMART GOAL Arm', 'description': 'The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), which will be used in tandem.\n\nThe study group participants will also be asked to summarize the information discussed during the visit, and then will receive the SMART (Specific, Measurable, Attainable, Realistic, Time sensitive) Goal Setting Protocol (SGSP).', 'interventionNames': ['Behavioral: SMART GOALS Setting Tool/ Protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Arm', 'description': 'Participants randomized to this group will receive standard of care.\n\nAt the end of each visit, the participants in the standard of care (SOC) group will be asked to provide a summary of topics discussed and what they plan to improve on from now and their next visit:'}], 'interventions': [{'name': 'SMART GOALS Setting Tool/ Protocol', 'type': 'BEHAVIORAL', 'description': 'The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), which will be used in tandem. The participant will first receive the SGSG which will highlight 3 domains of SMART goals (exercise, diet, and behavior). Each domain will have 1 predetermined and unchanging primary goal which will serve as the standard for all participants to strive for.', 'armGroupLabels': ['SMART GOAL Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11042', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rashida Talib, MPH', 'role': 'CONTACT', 'email': 'rtalib@northwell.edu', 'phone': '516-472-3631'}, {'name': 'Nessa Wardak', 'role': 'CONTACT', 'email': 'nwardak@northwell.edu', 'phone': '516-472-3631'}, {'name': 'Benjamin Nwosu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas Zachmann', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Audrey Koltun', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11042', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Zachmann', 'role': 'CONTACT'}], 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Thomas Zachmann, RD', 'role': 'CONTACT', 'email': 'tzachmann@northwell.edu', 'phone': '(516) 472-3750'}, {'name': 'Rashida Talib, MPH', 'role': 'CONTACT', 'email': 'rtalib@northwell.edu', 'phone': '(516)472-3631'}], 'overallOfficials': [{'name': 'Benjamin U. Nwosu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NORTHWELL HEALTH, INC.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}