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- Klinische proef NCT03012126
Clinical & Community Approaches to Weight Management (CORD 2)
3 februari 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
407
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 jaar tot 12 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Change in Child BMI at 12 months
Tijdsspanne: 0-12 months
|
0-12 months
|
Change in Child BMI percent of the 95th percentile at 12 months
Tijdsspanne: 0-12 months
|
0-12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Screen Time at 12 months
Tijdsspanne: 0-12 months
|
Average hours per day of screen time as reported by parent
|
0-12 months
|
Change in Sleep Duration at 12 months
Tijdsspanne: 0-12 months
|
Average hours per day of sleep as reported by parent
|
0-12 months
|
Change in Physical Activity at 12 months
Tijdsspanne: 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
Tijdsspanne: 0-12 months
|
Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent
|
0-12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Elsie Taveras, MD, MPH, MassGeneral Hospital for Children
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 december 2016
Primaire voltooiing (Werkelijk)
1 september 2019
Studie voltooiing (Werkelijk)
1 september 2019
Studieregistratiedata
Eerst ingediend
12 december 2016
Eerst ingediend dat voldeed aan de QC-criteria
5 januari 2017
Eerst geplaatst (Schatting)
6 januari 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 februari 2021
Laatste update ingediend die voldeed aan QC-criteria
3 februari 2021
Laatst geverifieerd
1 februari 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 937121
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Ja
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
Data can be requested by emailing the PI or Project Manager.
IPD-toegangscriteria voor delen
- 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.
IPD delen Ondersteunend informatietype
- Leerprotocool
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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