Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339440
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Pediatric Obesity Quality of Life Cardiovascular Risk Factor Behavioral: Hearts & Parks Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
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
Official Title: A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Intervention Group
Patients in this group will be receiving the Hearts and Parks intervention.
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.

No Intervention: Control Group
Patients in this group will continue receiving standard of care.



Primary Outcome Measures :
  1. Change in z-BMI [ Time Frame: Baseline, 6 months ]
  2. Change in heart rate [ Time Frame: baseline, 12 months ]
  3. Number of subjects enrolled versus number of subjects who meet min. participation criteria [ Time Frame: 12 months ]
    As measured by enrollment logs

  4. Change in molecular pathways dysregulated in pediatric obesity [ Time Frame: Baseline, 6 months ]
    Stool and blood samples

  5. Physical activity [ Time Frame: Up to 12 months ]
    child physical activity; objectively tracked with fitness tracker

  6. Change in child fitness [ Time Frame: baseline, 3 months, 12 months ]
    3 minute bench stepping test

  7. Change in Child Quality of Life [ Time Frame: baseline, 3 months, 12 months ]
    Composite score of Sizing Me Up Questionnaires

  8. 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)

  9. Change in FLASHE Food and Activity Screener Scores [ Time Frame: Baseline, 6 months, 12 months ]
    Questionnaire about child and parent nutrition and activity habits

  10. Change in fasting lipid profile [ Time Frame: Baseline, 6 months, 12 months ]
  11. Change in fasting glucose [ Time Frame: Baseline, 6 months, 12 months ]
  12. Change in alanine aminotransferase (A1) [ Time Frame: Baseline, 6 months, 12 months ]
  13. Change in child quality of life (2) [ Time Frame: baseline, 3 months, 12 months ]
    PROMIS Questionnaire (not composite score)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339440


Contacts
Layout table for location contacts
Contact: Sophie Ravanbakht 919-620-4732 sophie.ravanbakht@duke.edu
Contact: Alexandra Zizzi alexandra.zizzi@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke Children's Primary Care Roxboro Street Recruiting
Durham, North Carolina, United States, 27704
Contact: Sarah Armstrong, MD         
Durham Pediatrics at North Duke Street Recruiting
Durham, North Carolina, United States, 27704
Contact: Sarah Armstrong, MD         
Regional Pediatrics - North Durham Recruiting
Durham, North Carolina, United States, 27704
Contact: Sarah Armstrong, MD         
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Sarah Armstrong, MD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03339440    
Other Study ID Numbers: Pro00086684
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms