Clinical trial NCT05020314: Pediatric Healthy Weight Clinic
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: American Academy of Pediatrics
First posted: 2021-08-25
Enrollment: 191
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Child BMI at 12 months
timeFrame: 0-12 months
measure: Change in Child BMI percent of the 95th percentile at 12 months
timeFrame: 0-12 months
measure: Change in Child BMI z-score at 12 months
timeFrame: 0-12 months
Secondary outcomes:
measure: Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire
timeFrame: 0-12 months
measure: Change in Child Binge Eating at 12 months based on Questionnaire
timeFrame: 0-12 months
measure: Change in Child Parental Stress at 12 months based on Questionnaire
timeFrame: 0-12 months
measure: Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire
timeFrame: 0-12 months
measure: Change in Child Nutrition at 12 months based on Questionnaire
timeFrame: 0-12 months
measure: Change in Child Physical Activity at 12 months based on Questionnaire
timeFrame: 0-12 months
measure: Change in Child Sleep at 12 months based on Questionnaire
timeFrame: 0-12 months
measure: Change in Child Screen Time at 12 months based on Questionnaire
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
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.
citation: 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.
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.