[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07717658":3,"trial-entities:NCT07717658":144,"trial-summary:NCT07717658":149},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":52,"secondary_outcomes":57,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":14,"eligibility_criteria":84,"std_ages":108,"locations":110,"central_contacts":137,"overall_officials":141,"references":142,"see_also_links":143},"NCT07717658","STUDY00006548","Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care","RECRUITING","2027-12","2026-07","2026-07-21","2025-02-05","Tufts University","OTHER",false,"The proposed project aims to implement and evaluate a novel, family-based lifestyle medicine intervention integrating group Shared Medical Appointments (SMAs) for parents and adolescents with a twelve-month medically tailored groceries (MTG) and six-month culinary medicine Food is Medicine program. The intervention provides adolescent weight wellness treatment through a holistic, community engaged approach leveraging family connection, clinical care, and nutrition support. Monthly SMAs will include time for parents and adolescents to meet independently and conclude together. These visits will be co-led by physicians, dietitians, and health professionals. Parents will receive the Ardmore Institute's Full Plate Living program while adolescents receive Tufts Pediatrics Strong, Positive and Resilient Kids (SPARK) Weight Wellness program. The SMA format is reimbursable, fosters peer support, enhances patient-provider interaction, and allows efficient delivery of education and care. Each session will include nutrition and lifestyle education, review of individualized weight care plans, and proactive goal setting tailored to adults, adolescents, and families.",null,[18,19],"Obesity & Overweight","Weight Management",[21,22,23],"culinary medicine","medically tailored groceries","weight management","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},60,"ESTIMATED",[32,40,47],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"BEHAVIORAL","Culinary medicine classes","Culinary Education - Kids Test Kitchen: In Cohort 2, as part of the SMA, families will participate in six cooking classes. The curriculum emphasizes hands-on cooking, nutrition literacy, and family engagement.",[37],"Cohort 2: SMA, MTG, and Culinary medicine",[39],"Culinary medicine",{"type":33,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Medically Tailored Groceries","Medically Tailored Groceries (MTG): In Cohorts 2 and 3 families receive twelve months of MTG at $250 USD per month. Groceries are customized to clinical goals such as weight management, blood pressure control, and glycemic regulation.",[37,44],"Cohort 3: SMA and MTG",[46],"MTG",{"type":33,"name":48,"description":49,"armGroupLabels":50},"Shared Medical Appointments","Shared Medical Appointments (SMAs): Families will attend monthly 60-90-minute group visits. The SMAs will include separate parent and adolescent classes, followed by joint activities. Parent sessions will be led by Dr. Kane using the Ardmore Full Plate Living curriculum. Adolescent sessions will be led by Drs. Mauney and Bushard using the SPARK Wellness Program. Each SMA will integrate nutrition education, behavioral health support, and goal setting tailored to the patient and family needs.",[51,37,44],"Cohort 1: SMA only",[53],{"measure":54,"description":55,"timeFrame":56},"Change in BMI z-score","Measured using standardized CDC growth charts, obtained from EMR-recorded height and weight at in-person visits. Weight and height will be combined to report BMI in kg\u002Fm\\^2)","Baseline to 12 months",[58,62,65,67,69,72,75,78],{"measure":59,"description":60,"timeFrame":61},"Change in absolute BMI and waist circumference","Collected from EHR, weight and height will be combined to report BMI in kg\u002Fm\\^2.","Baseline to 12 months and 18 months (6-month post-program follow-up).",{"measure":63,"description":64,"timeFrame":56},"Laboratory measures (ALT)","Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)",{"measure":66,"description":64,"timeFrame":56},"Laboratory measures (hemoglobin A1C)",{"measure":68,"description":64,"timeFrame":56},"Laboratory measures (lipid panel)",{"measure":70,"description":71,"timeFrame":56},"Change in physical activity","Measured by questions adapted from:\n\n\\- Physical Activity Questionnaire for Adolescents 7-day recall, 1-5 scale Kowalski, K. C., Crocker, P. R. E., \\& Faulkner, R. A. (2004). The Physical Activity Questionnaire for Older Children (PAQ-C) and Adolescents (PAQ-A) Manual. College of Kinesiology, University of Saskatchewan",{"measure":73,"description":74,"timeFrame":56},"Change in media use","Measured by questions adapted from:\n\n\\- Cumulative Media Use Index Higher cumulative score on this index has been heavily associated with negative outcomes Score of 0: Low media exposure across all environments. Score of 1-2: Moderate or isolated media risk. Score of 3-4: High-risk, \"media-heavy ecology\" Linebarger, D. L., et al. (2014). Associations between parenting, media use, cumulative risk, and children's executive functioning. Journal of Developmental \\& Behavioral Pediatrics, 35(6), 367-377",{"measure":76,"description":77,"timeFrame":56},"Change in sleep","Measured by questions adapted from:\n\n\\- Short Form Children's Sleep Habits questionnaire Each question is rated on a 3-point scale based on how often the behavior occurs, total Score greater than 30 on the SF-CSHQ indicates behavioral sleep issues.\n\nOwens, J. A., Spirito, A., \\& McGuinn, M. (2000). The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Journal of American Academy of Child \\& Adolescent Psychiatry, 39(12), 1546-1553.",{"measure":79,"description":80,"timeFrame":56},"Change in health-related quality of life","Based on PedsQL child and parent reports","ALL","12 Years","17 Years",{"inclusion":85,"exclusion":96,"raw_text":107},[86,87,88,89,90,91,92,93,88,94,95],"Child aged 12-17 years at time of enrollment (inclusive)","BMI ≥ 95% for age and sex based on CDC growth charts","Comfortable speaking and reading English (due to limitations in intervention materials and qualitative data collection tools)","Child is an active patient at Tufts Medical Center","Child can provide assent, Willing and able to participate in the 18-month study, including attendance at scheduled in-person or telehealth sessions","Access to a device with internet capability (e.g., computer, tablet, or smartphone) to engage with online intervention","Age 18+ at time of enrollment","Primary caregiver is the legal guardian of the child","Can provide consent, Willing and able to participate in the 12-month study, including attendance at scheduled in-person or telehealth sessions","Access to a device with internet capability (e.g., computer, tablet, or smartphone) to engage with online intervention components.",[97,98,99,100,101,102,103,104,105,100,106],"Participation is medically or developmentally inappropriate, including but not limited to: Severe intellectual disability or cognitive impairment preventing meaningful participation, Active eating disorder diagnosis or concerning disordered eating behaviors, Severe physical limitations or mobility impairments that would limit participation in lifestyle activities, Active unmanaged psychiatric condition (e.g., acute suicidality or psychosis) that may interfere with participation or consent","Planned bariatric surgery or other weight loss procedures during the 12-month study period","Child is currently pregnant or plans to become so in the next 12 months","Plans to relocate or transfer care away from the participating clinic during the 12-month study period","Concurrent participation in another weight management clinical trial that could confound results or interfere with study activities","Parent is unwilling or unable to participate in the study","Child is a parent (has their own child), is in the armed forces, or lives independently and manages their own affairs (emancipated)","Child is a foster child, in state custody, or has an open DCF case pending as identified in the electronic medical record or disclosed verbally by child or guardian.","Severe intellectual disability or cognitive impairment preventing meaningful participation","Unwilling or unable to participate in the study.","Inclusion Criteria:\n\nFor children:\n\n* Child aged 12-17 years at time of enrollment (inclusive)\n* BMI ≥ 95% for age and sex based on CDC growth charts\n* Comfortable speaking and reading English (due to limitations in intervention materials and qualitative data collection tools)\n* Child is an active patient at Tufts Medical Center\n* Child can provide assent, Willing and able to participate in the 18-month study, including attendance at scheduled in-person or telehealth sessions\n* Access to a device with internet capability (e.g., computer, tablet, or smartphone) to engage with online intervention\n\nFor parents or guardians:\n\n* Age 18+ at time of enrollment\n* Primary caregiver is the legal guardian of the child\n* Comfortable speaking and reading English (due to limitations in intervention materials and qualitative data collection tools)\n* Can provide consent, Willing and able to participate in the 12-month study, including attendance at scheduled in-person or telehealth sessions\n* Access to a device with internet capability (e.g., computer, tablet, or smartphone) to engage with online intervention components.\n\nExclusion Criteria:\n\nFor Children:\n\n* Participation is medically or developmentally inappropriate, including but not limited to: Severe intellectual disability or cognitive impairment preventing meaningful participation, Active eating disorder diagnosis or concerning disordered eating behaviors, Severe physical limitations or mobility impairments that would limit participation in lifestyle activities, Active unmanaged psychiatric condition (e.g., acute suicidality or psychosis) that may interfere with participation or consent\n* Planned bariatric surgery or other weight loss procedures during the 12-month study period\n* Child is currently pregnant or plans to become so in the next 12 months\n* Plans to relocate or transfer care away from the participating clinic during the 12-month study period\n* Concurrent participation in another weight management clinical trial that could confound results or interfere with study activities\n* Parent is unwilling or unable to participate in the study\n* Child is a parent (has their own child), is in the armed forces, or lives independently and manages their own affairs (emancipated)\n* Child is a foster child, in state custody, or has an open DCF case pending as identified in the electronic medical record or disclosed verbally by child or guardian.\n\nFor parent:\n\n* Severe intellectual disability or cognitive impairment preventing meaningful participation\n* Plans to relocate or transfer care away from the participating clinic during the 12-month study period\n* Unwilling or unable to participate in the study.",[109],"CHILD",[111,128],{"facility":112,"status":7,"city":113,"state":114,"zip":115,"country":116,"contacts":117,"geoPoint":125},"Tufts Medical Center","Boston","Massachusetts","02111","United States",[118,123],{"name":119,"role":120,"phone":121,"email":122},"Erin Mauney, MD","CONTACT","(617) 636-3266","Erin.Mauney@tuftsmedicine.org",{"name":119,"role":124},"PRINCIPAL_INVESTIGATOR",{"lat":126,"lon":127},42.35843,-71.05977,{"facility":12,"status":7,"city":113,"state":114,"zip":115,"country":116,"contacts":129,"geoPoint":136},[130,134],{"name":131,"role":120,"phone":132,"email":133},"NICHE Lab Team","‪(469) 240-9112‬","niche@tufts.edu",{"name":135,"role":124},"Kelseanna Hollis-Hansen, PhD, MPH",{"lat":126,"lon":127},[138],{"name":139,"role":120,"phone":140,"email":133},"Kelseanna Hollis-Hansen, PhD","(469) 240-9112‬",[],[],[],{"nct_id":4,"conditions":145,"biomarkers":148},[146,147],"Obesity","Overweight",[],{"nct_id":4,"found":150,"summary":151,"prompt_version":161},true,{"design":152,"status":153,"heading":154,"summary":155,"follow_up":156,"word_count":157,"commitments":158,"compensation":159,"drugs_mentioned":160},"This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 60 participants.","completed","Family-Based Weight Wellness Treatment for Teens","This study is testing a family-based program to help teenagers manage their weight. It combines three main parts: Shared Medical Appointments (group visits with doctors, dietitians, and other health professionals), Medically Tailored Groceries (customized food delivered to your family for 12 months), and Culinary Medicine classes (hands-on cooking and nutrition education for 6 months). The goal is to see if these interventions can help improve a teenager's BMI z-score (a measure of body mass index relative to age and sex) over 12 months. This study is for teens aged 12-17 who have a BMI at or above the 95th percentile for their age and sex, and are active patients at Tufts Medical Center. The study plans to enroll 60 families, but its current recruitment status is unclear.","Participants will be followed for changes in BMI z-score from baseline to 12 months.",127,"Families will attend monthly 60-90-minute group visits, receive 12 months of customized groceries, and participate in six cooking classes.","Not stated in the trial record.",[34,41,48],"v2"]