Pediatric ObesityCORDNCT05020314
Pediatric Healthy Weight Clinic
A study testing Healthy Weight Clinic in people with Pediatric Obesity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The overall goal of this study is to increase access to and adoption of the Healthy Weight Clinic package in primary care settings serving low income families in the United States who have a disproportionately high prevalence of childhood obesity. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Healthy Weight Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 31 Dec 2023
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- child is age 2 through 18 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 or Spanish
- received care at one of the participating pilot sites
Who cannot join
- children who do not have at least one parent who can report on their child's daily activities for 1 year
- families who plan to leave their pediatric health center in the next year
- children who have conditions or take medications that substantially interfere with growth, physical activity, or dietary recommendations
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Healthy Weight Clinic: Packaging and Spreading Proven Pediatric Weight Management Interventions for Use by Low-Income Families, Childhood Obesity Research Demonstration Project (CORD) 3.0
The overall goal of this study is to increase access to and adoption of the Healthy Weight Clinic package in primary care settings serving low income families in the United States who have a disproportionately high prevalence of childhood obesity. Two federally-qualified health centers in Mississippi and two health centers in Massachusetts will be implementing a Healthy Weight Clinic Program. The Healthy Weight Clinic is staffed by a medical provider, a Dietitian/Nutritionist, and a Community Healthy Worker. Patients attend individual medical visits (once per month for 12 months) with the multidisciplinary team, group visits led by a member of the team (once per month for 6 months), and phone follow-up between visits. All patients who receive care at the pilot implementation sites will be exposed to the systems-level intervention. A subset of patients will be invited to participate in a research evaluation of the program.
- Conditions
- Pediatric Obesity
- Being tested
- Healthy Weight Clinic
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Weight ClinicBehavioural
Patients meet with a multi-disciplinary team over a 12 month period. In addition to the clinical visits, group visits, and phone calls, patients will also receive education materials, community resources, and an optional text messaging/social media library of messages.
| Study group | Role | What they receive |
|---|---|---|
| Clinically Based: Healthy Weight Clinic | Experimental | Not described Receives: Behavioral: Healthy Weight Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child BMI at 12 months
Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.
Measured: 0-12 months
Change in Child BMI percent of the 95th percentile at 12 months
Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.
Measured: 0-12 months
Change in Child BMI z-score at 12 months
Weight and height will be combined to report BMI z-score based on CDC growth curves
Measured: 0-12 months
Secondary outcomes (8)
Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire
Measured: 0-12 months
Change in Child Binge Eating at 12 months based on Questionnaire
Measured: 0-12 months
Change in Child Parental Stress at 12 months based on Questionnaire
Measured: 0-12 months
Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire
Measured: 0-12 months
Change in Child Nutrition at 12 months based on Questionnaire
Measured: 0-12 months
Change in Child Physical Activity at 12 months based on Questionnaire
Measured: 0-12 months
Change in Child Sleep at 12 months based on Questionnaire
Measured: 0-12 months
Change in Child Screen Time at 12 months based on Questionnaire
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.
- First posted25 Aug 2021
- Study start7 Oct 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Children receiving care at the implementation sites, and who are referred to and attend the Healthy Weight Clinic will receive the intervention as described. A sample of demographically matched children who did not receive the intervention will serve as a comparison group.
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, American Academy of Pediatrics
- Responsible party
- Principal investigator, Lauren G. Fiechtner, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020314
- Sponsor's protocol ID
- 2021P000258; 2023P003302
- Acronym
- CORD
- Status last verified
- Apr 2025
- First submitted
- 12 Aug 2021
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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, Sierra Velez D, Ayala SG, Castro I, Lindros J, Perkins M, Baker A, Salmon J, Biggs V, Cannon-Smith G, Smith JD, Simione M, Gortmaker SL, Taveras EM. Planned Evaluation of the Healthy Weight Clinic Pediatric Weight Management and Implementation: Massachusetts-CORD 3.0. Child Obes. 2021 Sep;17(S1):S55-S61. doi: 10.1089/chi.2021.0178.
PubMed 34569842Fiechtner L, Castro I, Ayala SG, Velez DS, Lindros J, Perkins M, Baker A, Salmon J, Biggs V, Cannon-Smith G, Smith JD, Simione M, Gortmaker SL, Taveras EM. Design and Approach of the Healthy Weight Clinic Pediatric Weight Management Intervention Package and Implementation: Massachusetts-CORD 3.0. Child Obes. 2021 Sep;17(S1):S48-S54. doi: 10.1089/chi.2021.0177.
PubMed 34569841Sierra-Velez D, Gundewar A, Persaud A, Simione M, Castro I, Perkins M, Lindros J, Salmon J, Smith JD, Taveras EM, Fiechtner L. Stakeholders' perception of factors influencing adoption of a pediatric weight management intervention: a qualitative study. Front Public Health. 2023 Oct 13;11:1045618. doi: 10.3389/fpubh.2023.1045618. eCollection 2023.
PubMed 37900042
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Weight Clinic: Packaging and Spreading Proven Pediatric Weight Management Interventions for Use by Low-Income Families, Childhood Obesity Research Demonstration Project (CORD) 3.0
- ClinicalTrials.gov ID
- NCT05020314
- Acronym / sponsor ID
- CORD / 2021P000258; 2023P003302
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, American Academy of Pediatrics
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to increase access to and adoption of the Healthy Weight Clinic package in primary care settings serving low income families in the United States who have a disproportionately high prevalence of childhood obesity. Two federally-qualified health centers in Mississippi and two health centers in Massachusetts will be implementing a Healthy Weight Clinic Program. The Healthy Weight Clinic is staffed by a medical provider, a Dietitian/Nutritionist, and a Community Healthy Worker. Patients attend individual medical visits (once per month for 12 months) with the multidisciplinary team, group visits led by a member of the team (once per month for 6 months), and phone follow-up between visits. All patients who receive care at the pilot implementation sites will be exposed to the systems-level intervention. A subset of patients will be invited to participate in a research evaluation of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children receiving care at the implementation sites, and who are referred to and attend the Healthy Weight Clinic will receive the intervention as described. A sample of demographically matched children who did not receive the intervention will serve as a comparison group.
| Arm | Type | Receives |
|---|---|---|
| Clinically Based: Healthy Weight Clinic | Experimental | Behavioral: Healthy Weight Clinic |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- child is age 2 through 18 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 or Spanish
- received care at one of the participating pilot sites
Key exclusion criteria (3 listed)
- children who do not have at least one parent who can report on their child's daily activities for 1 year
- families who plan to leave their pediatric health center in the next year
- children who have conditions or take medications that substantially interfere with growth, physical activity, or dietary recommendations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Weight ClinicPatients meet with a multi-disciplinary team over a 12 month period. In addition to the clinical visits, group visits, and phone calls, patients will also receive education materials, community resources, and an optional text messaging/social media library of messages. | Behavioural | Clinically Based: Healthy Weight Clinic |
Primary outcome
Change in Child BMI at 12 months
Time frame: 0-12 months
Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.
Change in Child BMI percent of the 95th percentile at 12 months
Time frame: 0-12 months
Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.
Change in Child BMI z-score at 12 months
Time frame: 0-12 months
Weight and height will be combined to report BMI z-score based on CDC growth curves
8 secondary outcomes
Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire
Time frame: 0-12 months
Change in Child Binge Eating at 12 months based on Questionnaire
Time frame: 0-12 months
Change in Child Parental Stress at 12 months based on Questionnaire
Time frame: 0-12 months
Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire
Time frame: 0-12 months
Change in Child Nutrition at 12 months based on Questionnaire
Time frame: 0-12 months
Change in Child Physical Activity at 12 months based on Questionnaire
Time frame: 0-12 months
Change in Child Sleep at 12 months based on Questionnaire
Time frame: 0-12 months
Change in Child Screen Time at 12 months based on Questionnaire
Time frame: 0-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 34569842Fiechtner L, Sierra Velez D, Ayala SG, Castro I, Lindros J, Perkins M, Baker A, Salmon J, Biggs V, Cannon-Smith G, Smith JD, Simione M, Gortmaker SL, Taveras EM. Planned Evaluation of the Healthy Weight Clinic Pediatric Weight Management and Implementation: Massachusetts-CORD 3.0. Child Obes. 2021 Sep;17(S1):S55-S61. doi: 10.1089/chi.2021.0178.
- Background: PubMed 34569841Fiechtner L, Castro I, Ayala SG, Velez DS, Lindros J, Perkins M, Baker A, Salmon J, Biggs V, Cannon-Smith G, Smith JD, Simione M, Gortmaker SL, Taveras EM. Design and Approach of the Healthy Weight Clinic Pediatric Weight Management Intervention Package and Implementation: Massachusetts-CORD 3.0. Child Obes. 2021 Sep;17(S1):S48-S54. doi: 10.1089/chi.2021.0177.
- Background: PubMed 37900042Sierra-Velez D, Gundewar A, Persaud A, Simione M, Castro I, Perkins M, Lindros J, Salmon J, Smith JD, Taveras EM, Fiechtner L. Stakeholders' perception of factors influencing adoption of a pediatric weight management intervention: a qualitative study. Front Public Health. 2023 Oct 13;11:1045618. doi: 10.3389/fpubh.2023.1045618. eCollection 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Weight Clinic in people with Pediatric Obesity, run by Massachusetts General Hospital at 1 site in United States.
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 4 inclusion and 3 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 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 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 NCT05020314, which also lists 3 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 15 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.