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A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)

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ClinicalTrials.gov Identifier: NCT03339440
Recruitment Status : Active, not recruiting
First Posted : November 13, 2017
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE January 10, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Change in z-BMI [ Time Frame: Baseline, 6 months ]
  • Change in heart rate [ Time Frame: baseline, 12 months ]
  • Number of subjects enrolled versus number of subjects who meet min. participation criteria [ Time Frame: 12 months ]
    As measured by enrollment logs
  • Change in molecular pathways dysregulated in pediatric obesity [ Time Frame: Baseline, 6 months ]
    Stool and blood samples
  • Physical activity [ Time Frame: Up to 12 months ]
    child physical activity; objectively tracked with fitness tracker
  • Change in child fitness [ Time Frame: baseline, 3 months, 12 months ]
    3 minute bench stepping test
  • Change in Child Quality of Life [ Time Frame: baseline, 3 months, 12 months ]
    Composite score of Sizing Me Up Questionnaires
  • Change in Body Appreciation [ Time Frame: baseline, 3 months, 12 months ]
    Body appreciation scale 13-item questionnaire (1. Never, 2. Seldom, 3. Sometimes, 4. Often, 5. Always)
  • Change in FLASHE Food and Activity Screener Scores [ Time Frame: Baseline, 6 months, 12 months ]
    Questionnaire about child and parent nutrition and activity habits
  • Change in fasting lipid profile [ Time Frame: Baseline, 6 months, 12 months ]
  • Change in fasting glucose [ Time Frame: Baseline, 6 months, 12 months ]
  • Change in alanine aminotransferase (A1) [ Time Frame: Baseline, 6 months, 12 months ]
  • Change in child quality of life (2) [ Time Frame: baseline, 3 months, 12 months ]
    PROMIS Questionnaire (not composite score)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)
Official Title  ICMJE A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Childhood Obesity
  • Pediatric Obesity
  • Quality of Life
  • Cardiovascular Risk Factor
Intervention  ICMJE Behavioral: Hearts & Parks
The Hearts & Parks intervention will be looking to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) through attendance and participation in the Duke Healthy Lifestyles/Bull City Fit clinic/community program, affect children's health. The investigators will be looking at changes in BMI, physical activity, nutrition and overall health.
Study Arms  ICMJE
  • Experimental: Intervention Group
    Patients in this group will be receiving the Hearts and Parks intervention.
    Intervention: Behavioral: Hearts & Parks
  • No Intervention: Control Group
    Patients in this group will continue receiving standard of care.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 13, 2020)
327
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
350
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03339440
Other Study ID Numbers  ICMJE Pro00086684
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah Armstrong, MD Duke University
PRS Account Duke University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP