Clinical & Community Approaches to Weight Management (CORD 2)
3 de febrero de 2021 actualizado por: Elsie Taveras, MD, Massachusetts General Hospital
Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)
This project seeks to build on innovative strategies to optimize the care of low-income children with a BMI ≥ 85th percentile.
To accomplish this goal, investigators will implement a new clinical-community intervention, theoretically grounded in the Integrated Clinical and Community Systems of Care Model, to address obesity through optimized screening and management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy Weight and Your Child weight management program (originally known as MEND).
The study will examine outcomes for children that matter most to a broad group of stakeholders including parents, clinicians, and public health practitioners as well as inform the care of >7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a 2-arm RCT.
Enrolled patients are randomized to a pediatric weight management intervention (PWMI): 1)a Healthy Weight Clinic based at a federally-qualified health center (FQHC), or 2) a modified Healthy Weight and Your Child intervention delivered in YMCAs.
A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.
Tipo de estudio
Intervencionista
Inscripción (Actual)
407
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años a 12 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- child is age 6.0 through 12.9 years at referral
- child's BMI meets or exceeds the 85th percentile for age and sex
- parent can read and respond to interviews and questionnaires in English and Spanish
Exclusion Criteria:
- children who do not have at least one parent who is able to follow study procedures for 1 year
- families who plan to leave their primary care health center within the study time frame
- families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties
- children who were taking medications that substantially interfere with growth
- children who have a sibling enrolled in the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Clinically Based: Healthy Weight Clinic
All families referred to the Healthy Weight Clinic intervention arm will be scheduled for a 30-45 minute orientation clinic visit to orient the child and family to the program.
During this visit, the family will meet with the community health worker who will provide a schedule of clinic visits and dietitian contacts.
The community health worker will assess the child's social and environmental context to allow treatment tailoring.
For the first 6 months, each family will be asked to attend two clinic visits per month and complete weekly 20-30 minute contacts with the dietitian via telephone.
The program aims to deliver approximately 30 contact hours in the 6-month period.
This will be followed by monthly visits to the Healthy Weight Clinic and monthly calls with their dietitian.
|
|
|
Experimental: Community Based: Healthy Weight & Your Child
All families referred to the Healthy Weight and Your Child intervention arm will be scheduled for a 60-minute family information session to orient the child and family to the program.
During this visit, the family will receive information about the program and logistics such as program schedule and format and attendance.
The program is delivered over 12 months, which includes 16 weekly sessions, followed by 4 sessions delivered every other week and concluding with 5 monthly sessions.
Most sessions are 2 hours in length and include a group of about 8-15 children and their caregivers.
The first hour is delivered in a classroom setting and the second hour in an additional area conducive for physical activity.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in Child BMI at 12 months
Periodo de tiempo: 0-12 months
|
0-12 months
|
|
Change in Child BMI percent of the 95th percentile at 12 months
Periodo de tiempo: 0-12 months
|
0-12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Screen Time at 12 months
Periodo de tiempo: 0-12 months
|
Average hours per day of screen time as reported by parent
|
0-12 months
|
|
Change in Sleep Duration at 12 months
Periodo de tiempo: 0-12 months
|
Average hours per day of sleep as reported by parent
|
0-12 months
|
|
Change in Physical Activity at 12 months
Periodo de tiempo: 0-12 months
|
Average number of days (0-7) child is physically active for at least 60 minutes as reported by parent
|
0-12 months
|
|
Change in Diet at 12 months
Periodo de tiempo: 0-12 months
|
Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent
|
0-12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elsie Taveras, MD, MPH, MassGeneral Hospital for Children
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Fiechtner L, Perkins M, Biggs V, Langhans N, Sharifi M, O'Connor G, Price S, Locascio J, Kuhlthau K, Kwass JA, Nelson C, Land T, Longjohn M, Lawson V, Hohman K, Taveras EM. Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial. Contemp Clin Trials. 2018 Apr;67:16-22. doi: 10.1016/j.cct.2018.01.002. Epub 2018 Jan 10.
- Fay C, Castro I, Sierra Velez D, Ruggiero CF, O'Connor G, Perkins M, Luo M, Sharifi M, Neri Mini F, Taveras EM, Kuhlthau K, Fiechtner L. Keys to Achieving Clinically Important Weight Loss: Perceptions of Responders and Nonresponders in the Clinic and Community Approaches to Healthy Weight Trial. Child Obes. 2022 Oct 28. doi: 10.1089/chi.2022.0112. Online ahead of print.
- Harshman SG, Castro I, Perkins M, Luo M, Barrett Mueller K, Cena H, Portale S, Raspini B, Taveras E, Fiechtner L. Pediatric weight management interventions improve prevalence of overeating behaviors. Int J Obes (Lond). 2022 Mar;46(3):630-636. doi: 10.1038/s41366-021-00989-x. Epub 2021 Dec 3.
- Sierra Velez D, Simione M, Castro I, Perkins M, Luo M, Taveras EM, Fiechtner L. Effects of a Pediatric Weight Management Intervention on Parental Stress. Child Obes. 2022 Apr;18(3):160-167. doi: 10.1089/chi.2021.0146. Epub 2021 Oct 7.
- Fiechtner L, Perkins M, Biggs V, Langhans N, Sharifi M, Price S, Luo M, Locascio JJ, Hohman KH, Hodge H, Gortmaker S, Torres S, Taveras EM. Comparative Effectiveness of Clinical and Community-Based Approaches to Healthy Weight. Pediatrics. 2021 Oct;148(4):e2021050405. doi: 10.1542/peds.2021-050405. Epub 2021 Sep 1.
- Atkins M, Castro I, Sharifi M, Perkins M, O'Connor G, Sandel M, Taveras EM, Fiechtner L. Unmet Social Needs and Adherence to Pediatric Weight Management Interventions: Massachusetts, 2017-2019. Am J Public Health. 2020 Jul;110(S2):S251-S257. doi: 10.2105/AJPH.2020.305772.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de diciembre de 2016
Finalización primaria (Actual)
1 de septiembre de 2019
Finalización del estudio (Actual)
1 de septiembre de 2019
Fechas de registro del estudio
Enviado por primera vez
12 de diciembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
5 de enero de 2017
Publicado por primera vez (Estimar)
6 de enero de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de febrero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
3 de febrero de 2021
Última verificación
1 de febrero de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 937121
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, IRB approval has been obtained, and all necessary data sharing agreements have been executed.
Marco de tiempo para compartir IPD
Data can be requested by emailing the PI or Project Manager.
Criterios de acceso compartido de IPD
- An analysis plan is prepared and approved by the PI/Co-Is
- IRB approval has been obtained, and
- all necessary data sharing agreements have been executed.
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Sobrepeso y Obesidad
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Ensayos clínicos sobre Healthy Weight Clinic
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Duke UniversityTerminado
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McMaster UniversityCanadian Institutes of Health Research (CIHR); Hamilton Academic Health Sciences...TerminadoEnfermedades cardiovasculares | Diabetes mellitusCanadá
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University of RochesterTerminadoObesidad | Exceso de pesoEstados Unidos
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University of North Carolina, Chapel HillWeight Watchers InternationalTerminadoSobrepeso y ObesidadEstados Unidos
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University Hospital, GhentTerminado
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University of PennsylvaniaWeight Watchers InternationalTerminado
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Pierre Fabre Dermo CosmetiqueAún no reclutando
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Stephen WhitesideNational Institute of Mental Health (NIMH)Terminado
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University of OttawaTerminadoAgotamiento, Profesional | Estrés, Emocional | ResilienciaCanadá