AzTrials
AzTrials

Overweight and ObesityCORD 2NCT03012126

Clinical & Community Approaches to Weight Management

A study testing Healthy Weight Clinic and Healthy Weight and Your Child in people with Overweight and Obesity, run by Massachusetts General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Overweight and Obesity
What is being tested?
Healthy Weight Clinic and Healthy Weight and Your Child
Could I receive a placebo?
No, everyone receives an active treatment
How many people
407 participants
Where
No sites listed yet
Study dates
Dec 2016to Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Healthy Weight Clinic, Healthy Weight and Your Child
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Weight ClinicBehavioural

  • Healthy Weight and Your ChildBehavioural

Study groups in NCT03012126
Study groupRoleWhat they receive
Clinically Based: Healthy Weight ClinicExperimentalAll 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.
Receives: Behavioral: Healthy Weight Clinic
Community Based: Healthy Weight & Your ChildExperimentalAll 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.
Receives: Behavioral: Healthy Weight and Your Child

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Child BMI at 12 months

    Measured: 0-12 months

  2. Change in Child BMI percent of the 95th percentile at 12 months

    Measured: 0-12 months

Secondary outcomes (4)

  1. Change in Screen Time at 12 months

    Average hours per day of screen time as reported by parent

    Measured: 0-12 months

  2. Change in Sleep Duration at 12 months

    Average hours per day of sleep as reported by parent

    Measured: 0-12 months

  3. Change in Physical Activity at 12 months

    Average number of days (0-7) child is physically active for at least 60 minutes as reported by parent

    Measured: 0-12 months

  4. Change in Diet at 12 months

    Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent

    Measured: 0-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionSep 2019
  4. Study completionSep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Children were randomized to either: 1) federally qualified health center-based Healthy Weight Clinic, or 2) YMCA community-based Healthy Weight and Your Child Program. A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03012126
Sponsor's protocol ID
937121
Acronym
CORD 2
Status last verified
Feb 2021
First submitted
12 Dec 2016
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 29330083

  • 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. 2023 Dec;19(8):507-514. doi: 10.1089/chi.2022.0112. Epub 2022 Oct 28.

    PubMed 36315223

  • 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.

    PubMed 34862470

  • 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.

    PubMed 34619054

  • 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.

    PubMed 34470816

  • 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.

    PubMed 32663093

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Weight Clinic and Healthy Weight and Your Child in people with Overweight and Obesity, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Child BMI at 12 months (time frame: 0-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03012126, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in