- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07717658
Family-Based Weight Wellness Treatment Through Food is Medicine and Group Medical Visits in Pediatric and Adult Primary Care
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kelseanna Hollis-Hansen, PhD
- 전화번호: (469) 240-9112
- 이메일: niche@tufts.edu
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02111
- 모병
- Tufts Medical Center
-
연락하다:
- Erin Mauney, MD
- 전화번호: (617) 636-3266
- 이메일: Erin.Mauney@tuftsmedicine.org
-
수석 연구원:
- Erin Mauney, MD
-
Boston, Massachusetts, 미국, 02111
- 모병
- Tufts University
-
수석 연구원:
- Kelseanna Hollis-Hansen, PhD, MPH
-
연락하다:
- NICHE Lab Team
- 전화번호: (469) 240-9112
- 이메일: niche@tufts.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
For children:
- 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
For parents or guardians:
- Age 18+ at time of enrollment
- Primary caregiver is the legal guardian of the child
- Comfortable speaking and reading English (due to limitations in intervention materials and qualitative data collection tools)
- 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.
Exclusion Criteria:
For Children:
- 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.
For parent:
- Severe intellectual disability or cognitive impairment preventing meaningful participation
- Plans to relocate or transfer care away from the participating clinic during the 12-month study period
- Unwilling or unable to participate in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Cohort 1: SMA only
SMA group visits only
|
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.
|
|
실험적: Cohort 2: SMA, MTG, and Culinary medicine
SMA group visits + MTG + culinary medicine classes embedded within SMAs.
|
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.
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.
다른 이름들:
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.
다른 이름들:
|
|
실험적: Cohort 3: SMA and MTG
SMA group visits + MTG only.
|
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.
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in BMI z-score
기간: Baseline to 12 months
|
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/m^2)
|
Baseline to 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in absolute BMI and waist circumference
기간: Baseline to 12 months and 18 months (6-month post-program follow-up).
|
Collected from EHR, weight and height will be combined to report BMI in kg/m^2.
|
Baseline to 12 months and 18 months (6-month post-program follow-up).
|
|
Laboratory measures (ALT)
기간: Baseline to 12 months
|
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
|
Baseline to 12 months
|
|
Laboratory measures (hemoglobin A1C)
기간: Baseline to 12 months
|
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
|
Baseline to 12 months
|
|
Laboratory measures (lipid panel)
기간: Baseline to 12 months
|
Collected from EHR, venipuncture for blood collection through Tufts Medical Center (LabCorp)
|
Baseline to 12 months
|
|
Change in physical activity
기간: Baseline to 12 months
|
Measured by questions adapted from: - 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 |
Baseline to 12 months
|
|
Change in media use
기간: Baseline to 12 months
|
Measured by questions adapted from: - 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 |
Baseline to 12 months
|
|
Change in sleep
기간: Baseline to 12 months
|
Measured by questions adapted from: - 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. Owens, 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. |
Baseline to 12 months
|
|
Change in health-related quality of life
기간: Baseline to 12 months
|
Based on PedsQL child and parent reports
|
Baseline to 12 months
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00006548
- 1267-Spring 2026 (기타 보조금/기금 번호: Ardmore Institute)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .