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Parks & Pediatrics Fit Together

Primary Purpose

Pediatric Obesity, Implementation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit Together
Educational materials
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Physical Activity, Pediatrics

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child receives primary care at one of the participating clinics
  • Child age 6-11 years old at the time of enrollment in the study
  • BMI greater than or equal to 95th percentile for age and sex
  • English- or Spanish-speaking

Exclusion Criteria:

  • BMI above 160% of 95th percentile

Inclusion criteria for caregivers:

  • Age 18 or older
  • English or Spanish-speaking
  • Caregiver has smartphone and is willing to download app(s) used in the study
  • Anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours (necessary in order to accurately answer survey questions about child behavior and child participation in the program, and provide feedback about the program)
  • Does not have plans to leave the area during the next 12 months

Sites / Locations

  • Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF)
  • Waughtown Pediatrics (NHFMCF)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fit Together

Control

Arm Description

Participants in the intervention arm will receive standard of care obesity treatment from their provider and be able to participate in the Fit Together program and attend activity sessions throughout the duration of their 12 month participation.

Participants in the control arm will receive standard of care obesity treatment from their provider and a healthy cooking magazine mailed to them at a regular interval throughout the duration of their 12 month participation

Outcomes

Primary Outcome Measures

Change in percent of the 95th percentile for BMI Collected from clinic records.
Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records
Proportion of children with 26 hours or more of intervention contact
Measured by program attendance
Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker
Change in physical activity measured by Garmin vivofit4 fitness tracker

Secondary Outcome Measures

Change in self-report physical activity
Measured by the Evaluation of Activity Surveys in Youth (EASY); Scoring: range 0-88, higher scores indicate more activity
Change in quality of life
Measured by Sizing Them Up; Scoring: range 0-100, higher scores indicate better health-related quality of life
Unintended Consequences as measured by adverse events
Measured by collecting adverse events throughout participation
Patient Satisfaction at 6 months
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Patient Satisfaction at 12 months
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Change in diet quality
Measured by the Dietary Screener Questionnaire (DSQ)
Healthcare utilization
Measured by electronic health records
Cost effects
Cost impact (summative or incremental) to the unit or organization resulting from changes in health care utilization and efficiency. Fixed and variable costs; offsets of the cost of implementation. Collected as project administrative data, surveys with clinics and P&R sites to assess additional costs.

Full Information

First Posted
July 1, 2022
Last Updated
May 10, 2023
Sponsor
Duke University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05455190
Brief Title
Parks & Pediatrics Fit Together
Official Title
Parks & Pediatrics Fit Together: Translating Knowledge Into Action for Child Obesity Treatment in Partnership With Parks and Recreation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.
Detailed Description
Evidence-based treatment for childhood obesity exists, yet a fundamental knowledge-to-action gap has significantly limited the uptake of recommendations into clinical practice, particularly in low-income settings. Persistence of this gap represents a large-scale public health threat, as the earliest generation of children living through the obesity epidemic now enters adulthood, they are the first in US history to have a shorter life expectancy than their parents, mainly due to rising rates of obesity-related cancers and cardiovascular disease. A central challenge in delivering recommended treatment is the intensity; ≥26 hours of face-to-face contact are necessary to achieve health benefits and risk reduction. The objective of the proposed project is to develop and test an implementation strategy that pairs primary care pediatric clinics with the municipal Parks and Recreation (P&R) centers to deliver the current treatment recommendations with high fidelity, while allowing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Implementation
Keywords
Physical Activity, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fit Together
Arm Type
Experimental
Arm Description
Participants in the intervention arm will receive standard of care obesity treatment from their provider and be able to participate in the Fit Together program and attend activity sessions throughout the duration of their 12 month participation.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants in the control arm will receive standard of care obesity treatment from their provider and a healthy cooking magazine mailed to them at a regular interval throughout the duration of their 12 month participation
Intervention Type
Behavioral
Intervention Name(s)
Fit Together
Intervention Description
Fit Together intervention follows a clinic and community partnership model for childhood obesity treatment. Children with obesity will receive standard of care obesity treatment from their usual provider and will also receive a referral to an activity program run out of the local community center. Each session delivers a combination of high-intensity individual exercises, sports and games, and unstructured playtime to help children reach the US Physical Activity guidelines of 60min moderate-to-vigorous physical activity daily. There will also be a nutrition activity session offered regularly.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.
Primary Outcome Measure Information:
Title
Change in percent of the 95th percentile for BMI Collected from clinic records.
Description
Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records
Time Frame
Baseline, 6 months, and 12 months
Title
Proportion of children with 26 hours or more of intervention contact
Description
Measured by program attendance
Time Frame
Up to 12 months
Title
Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker
Description
Change in physical activity measured by Garmin vivofit4 fitness tracker
Time Frame
Baseline up to 12 months
Secondary Outcome Measure Information:
Title
Change in self-report physical activity
Description
Measured by the Evaluation of Activity Surveys in Youth (EASY); Scoring: range 0-88, higher scores indicate more activity
Time Frame
Baseline, 6 months, and 12 months
Title
Change in quality of life
Description
Measured by Sizing Them Up; Scoring: range 0-100, higher scores indicate better health-related quality of life
Time Frame
Baseline, 6 months, and 12 months
Title
Unintended Consequences as measured by adverse events
Description
Measured by collecting adverse events throughout participation
Time Frame
Up to 12 months
Title
Patient Satisfaction at 6 months
Description
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Time Frame
6 months
Title
Patient Satisfaction at 12 months
Description
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Time Frame
12 months
Title
Change in diet quality
Description
Measured by the Dietary Screener Questionnaire (DSQ)
Time Frame
Baseline, 6 months, 12 months
Title
Healthcare utilization
Description
Measured by electronic health records
Time Frame
Up to 12 months
Title
Cost effects
Description
Cost impact (summative or incremental) to the unit or organization resulting from changes in health care utilization and efficiency. Fixed and variable costs; offsets of the cost of implementation. Collected as project administrative data, surveys with clinics and P&R sites to assess additional costs.
Time Frame
Throughout program implementation duration (approx. 30 months)
Other Pre-specified Outcome Measures:
Title
Fidelity
Description
Degree to which the program was implemented as intended. Collected via structured observations of program sessions using System for Observing Play and Leisure Activity in Youth (SOPLAY)
Time Frame
Throughout program implementation duration (approx. 30 months)
Title
Implementation characteristics
Description
Barriers and facilitators to implementation collected via survey and qualitative interviews with stakeholders
Time Frame
Throughout program implementation duration (approx. 30 months)
Title
Assessment of harms related to the program
Description
Measured by assessment of harms survey; Scoring: ranging 5-25, higher scores indicate higher harms
Time Frame
Up through 12 months
Title
Change in mental health
Description
Measured by Pediatric Symptom Checklist (PSC-17); Scoring: range 0-34, higher scores can indicate increased likelihood of behavioral health disorder
Time Frame
Baseline, 6 months, 12 months
Title
Change in blood pressure
Description
Obtained from medical records
Time Frame
Baseline, 6 months, 12 months
Title
Proportion of eligible children referred to the intervention
Description
Proportion of eligible children who are referred to the intervention, collected via program tracking materials/referrals received and EHR
Time Frame
Up through end of enrollment period (approx. 18 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child receives primary care at one of the participating clinics Child age 6-11 years old at the time of enrollment in the study BMI greater than or equal to 95th percentile for age and sex English- or Spanish-speaking Exclusion Criteria: Injuries or disabilities preventing physical activity. Inclusion criteria for caregivers: Age 18 or older English or Spanish-speaking Caregiver has smartphone and is willing to download app(s) used in the study Anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours (necessary in order to accurately answer survey questions about child behavior and child participation in the program, and provide feedback about the program) Does not have plans to leave the area during the next 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valery R Arevalo
Phone
9198668089
Email
valery.arevalo@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Janna Howard
Email
janna.howard@duke.edu
Facility Information:
Facility Name
Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Hammill
Email
whammill@novanthealth.org
Facility Name
Waughtown Pediatrics (NHFMCF)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lia Erickson
Email
lserickson@novanthealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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