Pediatric Healthy Weight Clinic

Pediatric Obesity Clinical Trial

— CORD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020314
• Other study ID #: 2021P000258
• Status: Completed
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Healthy Weight Clinic
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Academy of Pediatrics, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fiechtner 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. — View Citation

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. — View Citation

Sierra-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-12 months
Primary	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.	0-12 months
Primary	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	0-12 months
Secondary	Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire		0-12 months
Secondary	Change in Child Binge Eating at 12 months based on Questionnaire		0-12 months
Secondary	Change in Child Parental Stress at 12 months based on Questionnaire		0-12 months
Secondary	Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire		0-12 months
Secondary	Change in Child Nutrition at 12 months based on Questionnaire		0-12 months
Secondary	Change in Child Physical Activity at 12 months based on Questionnaire		0-12 months
Secondary	Change in Child Sleep at 12 months based on Questionnaire		0-12 months
Secondary	Change in Child Screen Time at 12 months based on Questionnaire		0-12 months