Clinical trial NCT03339440: A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)
Official title: A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Pediatric Obesity
Quality of Life
Cardiovascular Risk Factor
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 327
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will use a two-arm, randomized crossover controlled trial to compare routine primary care management of childhood obesity versus a novel clinic/family/community partnership program to treat childhood obesity. This design will allow for a randomized comparison of Group 1 (6-month standard control) to Group 2 (immediate 6-month intervention program) and to Group 3 (delayed crossover intervention on the standard control group). The design will also allow the investigators to observe intervention effects at 3 months in both intervention groups (Groups 2 and 3), and to track Group 2 for 6 additional months after active intervention to assess whether health benefits seen at 6 months were sustained to 12 months.
Primary purpose: TREATMENT

Brief summary: The investigators propose a randomized controlled effectiveness trial to evaluate the integrated clinic-community model of child obesity treatment as compared with routine primary care.

Detailed description: The purpose of this study is to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) affect children's health. The investigators will be looking at changes in child BMI, physical activity, nutrition, and overall health. The investigators also hope to better understand biological differences in metabolism and the microbiome (the bacteria that grows normally on and in the body) in children with high BMI who are making lifestyle changes.

Eligibility criteria: Inclusion Criteria:

* Child age 5-18 years
* Child body mass index ≥ 95th %ile
* Parent can speak and read in English or Spanish
* Parent ownership of a device that is able to receive and send text messages

Exclusion Criteria:

* Live farther than a 20-mile radius from the Healthy and Fit program site
* Endogenous or genetic cause of obesity
* Taking a medication that causes weight gain
* Participation in a pediatric weight management program within 12 months
* Parent or child significant health problem that would limit participation
* Enrollment is above the max weekly enrollment of 60 participants/week)
* Reported or planned pregnancy

Opt-out Criteria

• Primary care physician opts patient out of study for reasons including: severe obesity, urgent co-morbidities, parental unwillingness to be contacted by a research assistant, or at physician clinical judgment.

Primary outcomes:
measure: Change in z-BMI
timeFrame: Baseline, 6 months
measure: Change in heart rate
timeFrame: baseline, 12 months
measure: Number of subjects enrolled versus number of subjects who meet min. participation criteria
timeFrame: 12 months
measure: Change in molecular pathways dysregulated in pediatric obesity
timeFrame: Baseline, 6 months
measure: Physical activity
timeFrame: Up to 12 months
measure: Change in child fitness
timeFrame: baseline, 3 months, 12 months
measure: Change in Child Quality of Life
timeFrame: baseline, 3 months, 12 months
measure: Change in Body Appreciation
timeFrame: baseline, 3 months, 12 months
measure: Change in FLASHE Food and Activity Screener Scores
timeFrame: Baseline, 6 months, 12 months
measure: Change in fasting lipid profile
timeFrame: Baseline, 6 months, 12 months
measure: Change in fasting glucose
timeFrame: Baseline, 6 months, 12 months
measure: Change in alanine aminotransferase (A1)
timeFrame: Baseline, 6 months, 12 months
measure: Change in child quality of life (2)
timeFrame: baseline, 3 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Children's Primary Care Roxboro Street
state: North Carolina
city: Durham
country: United States
facility: Durham Pediatrics at North Duke Street
state: North Carolina
city: Durham
country: United States
facility: Regional Pediatrics - North Durham
state: North Carolina
Study officials:
affiliation: Duke University
name: Sarah Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neshteruk CD, Zizzi A, Suarez L, Erickson E, Kraus WE, Li JS, Skinner AC, Story M, Zucker N, Armstrong SC. Weight-Related Behaviors of Children with Obesity during the COVID-19 Pandemic. Child Obes. 2021 Sep;17(6):371-378. doi: 10.1089/chi.2021.0038. Epub 2021 Apr 26.
citation: Armstrong SC, Windom M, Bihlmeyer NA, Li JS, Shah SH, Story M, Zucker N, Kraus WE, Pagidipati N, Peterson E, Wong C, Wiedemeier M, Sibley L, Berchuck SI, Merrill P, Zizzi A, Sarria C, Dressman HK, Rawls JF, Skinner AC. Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity. BMC Pediatr. 2020 Jun 26;20(1):308. doi: 10.1186/s12887-020-02190-x.