- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03012126
Clinical & Community Approaches to Weight Management (CORD 2)
3. februar 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
407
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 12 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Child BMI at 12 months
Tidsramme: 0-12 months
|
0-12 months
|
Change in Child BMI percent of the 95th percentile at 12 months
Tidsramme: 0-12 months
|
0-12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Screen Time at 12 months
Tidsramme: 0-12 months
|
Average hours per day of screen time as reported by parent
|
0-12 months
|
Change in Sleep Duration at 12 months
Tidsramme: 0-12 months
|
Average hours per day of sleep as reported by parent
|
0-12 months
|
Change in Physical Activity at 12 months
Tidsramme: 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
Tidsramme: 0-12 months
|
Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent
|
0-12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Elsie Taveras, MD, MPH, MassGeneral Hospital for Children
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2016
Primær færdiggørelse (Faktiske)
1. september 2019
Studieafslutning (Faktiske)
1. september 2019
Datoer for studieregistrering
Først indsendt
12. december 2016
Først indsendt, der opfyldte QC-kriterier
5. januar 2017
Først opslået (Skøn)
6. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 937121
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
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-delingstidsramme
Data can be requested by emailing the PI or Project Manager.
IPD-delingsadgangskriterier
- 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-deling Understøttende informationstype
- Studieprotokol
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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