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Clinical & Community Approaches to Weight Management (CORD 2)

3 februari 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

407

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 år till 12 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: Healthy Weight Clinic
Experimentell: 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.
Beteende: Healthy Weight and Your Child

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change in Child BMI at 12 months
Tidsram: 0-12 months
0-12 months
Change in Child BMI percent of the 95th percentile at 12 months
Tidsram: 0-12 months
0-12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Screen Time at 12 months
Tidsram: 0-12 months
Average hours per day of screen time as reported by parent
0-12 months
Change in Sleep Duration at 12 months
Tidsram: 0-12 months
Average hours per day of sleep as reported by parent
0-12 months
Change in Physical Activity at 12 months
Tidsram: 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
Tidsram: 0-12 months
Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent
0-12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Massachusetts General Hospital

Samarbetspartners

Harvard School of Public Health (HSPH)
Massachusetts Department of Health
Y-USA
Yale School of Medicine

Utredare

  • Huvudutredare: Elsie Taveras, MD, MPH, MassGeneral Hospital for Children

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 december 2016

Primärt slutförande (Faktisk)

1 september 2019

Avslutad studie (Faktisk)

1 september 2019

Studieregistreringsdatum

Först inskickad

12 december 2016

Först inskickad som uppfyllde QC-kriterierna

5 januari 2017

Första postat (Uppskatta)

6 januari 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 februari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 februari 2021

Senast verifierad

1 februari 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 937121

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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.

Tidsram för IPD-delning

Data can be requested by emailing the PI or Project Manager.

Kriterier för IPD Sharing Access

  1. An analysis plan is prepared and approved by the PI/Co-Is
  2. IRB approval has been obtained, and
  3. all necessary data sharing agreements have been executed.

IPD-delning som stöder informationstyp

  • Studieprotokoll

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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