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Active Recreation Through Community-Healthcare Engagement Study (ARCHES)

Primary Purpose

Childhood Obesity, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated community-healthcare childhood obesity treatment
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring childhood obesity

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Sampling:

- Patients enrolled by their physician in the clinic-community program

Inclusion:

  • Child aged 2-17 years
  • Child with age- and gender-specific BMI ≥ 85th percentile

Exclusion:

  • Inability to read and write in English or Spanish
  • Parent with severe medical or mental health condition limiting ability to attend appointments
  • Child with severe medical or mental health condition limiting ability to attend appointments or participate in behavioral therapies
  • Parent and child live greater than 50 miles from the clinic and community center
  • Plan to move out of state in the next 6 months, or plan to live in another state for 2 months or longer within the next 6 months (ex., summer vacation).
  • Child with medical condition as cause of obesity (e.g., hypothyroidism, Cushing's Syndrome, Prader-Willi Syndrome, drug-induced obesity)

Sites / Locations

  • First Health
  • East Durham Children's Initiative
  • Duke Healthy Lifestyles
  • Better Health
  • Goldsboro Parks and Recreation
  • Wake Med
  • Healthy Rowan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Durham County

Richmond/Montgomery Counties

TBD

To be determined

Arm Description

The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.

The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.

The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.

The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.

Outcomes

Primary Outcome Measures

Eligibility
Number of eligible patients
Referral
Number of referred patients
Enrollment
Number of patients referred who enroll
Attendance
Number of participants present at each activity session
Fidelity
Measured by program post-session evaluation survey
Change in quality of life
Measured by Sizing me Up survey
Change in height
Change in nutrition habits (self report)
Food insecurity
Measured by The Hunger Vital Sign food insecurity assessment
Change in cardiovascular fitness
Patient satisfaction
Measured by patient satisfaction survey
Change in social cohesion
Measured by social cohesion questionnaire
Change in weight
Change in activity (self report)

Secondary Outcome Measures

Full Information

First Posted
August 4, 2017
Last Updated
August 13, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03246763
Brief Title
Active Recreation Through Community-Healthcare Engagement Study
Acronym
ARCHES
Official Title
Active Recreation Through Community-Healthcare Engagement Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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

5. Study Description

Brief Summary
Current obesity treatment guidelines recommend 26 or more hours of behavior treatment, delivered over a 6-month period in a multidisciplinary weight management clinic. However, this guideline is not feasible in real-world clinic settings where medical visits are costly and poorly reimbursed, and attrition is high, particularly among the most vulnerable children. The National Collaborative on Child Obesity Research has issued a call for research investigating healthcare-community partnerships to improve the effectiveness of child obesity treatment. The World Health Organization supports this approach, and in 2015 modified the chronic disease model to include healthcare-community integration. ARCHES is a three-year project that will develop and evaluate an effective, engaging, and scalable community-healthcare treatment option for low-income and racially diverse children. The project engages four communities in North Carolina and facilitates a local clinic-community partnership, supports the development of an integrated childhood obesity treatment program, and evaluates the feasibility of the integrated program model. The effectiveness of the integrated model will also be evaluated, as we will monitor patient outcomes associated with participation. Participation among teens (ages 11-18) will be incentivized where teen/caregiver dyads will be randomized to a gain or loss frame group at the beginning of the study and have the opportunity to receive and redeem points for attending sessions. Patient and process outcomes associated with participation in the integrated model with and without financial incentives will be evaluated.
Detailed Description
The investigators propose a three-year project to evaluate the implementation feasibility and effectiveness of an integrated clinic-community model of child obesity treatment. The investigators will engage four communities in North Carolina, facilitate a local clinic-community partnership, support the development of an integrated child obesity treatment program, and monitor outcomes. To evaluate implementation feasibility the investigators will measure fidelity, reach, acceptability, uptake and cost. To evaluate the program model the investigators will conduct a classical program evaluation by monitoring aggregate referral, enrollment and attendance data, as well as safety and patient satisfaction. To report patient outcomes associated with participation in the integrated model, the investigators will measure participant-level outcomes over a 6-month period, including changes in nutrition and physical activity behaviors, quality of life, cardiovascular fitness, and body mass index.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Quality of Life
Keywords
childhood obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will conduct a mixed-methods study using focus groups and interviews to explore the facilitators and barriers to program implementation, and a time-series analysis to examine program engagement and individual health outcomes. This study design will be repeated at each of the four sites. Aim 1 will consent and enroll program providers to obtain qualitative feedback on program design and implementation; Aim 2 will collect de-identified program-level data on attendance and program components; Aim 3 will consent patients for individual-level baseline and outcomes data.Subjects will be enrolled at our community sites. A research assistant will conduct all the enrollment, consent, and data collection. Where needed, the investigators will report or obtain required IRB authorization agreements for each site, including Federal Wide Assurances, Data Transfer Agreements, or other documents as required by federal regulation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Durham County
Arm Type
Experimental
Arm Description
The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
Arm Title
Richmond/Montgomery Counties
Arm Type
Experimental
Arm Description
The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
Arm Title
TBD
Arm Type
Experimental
Arm Description
The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
Arm Title
To be determined
Arm Type
Experimental
Arm Description
The intervention will include nutrition and fitness programming at a community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of comprehensive wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
Intervention Type
Behavioral
Intervention Name(s)
Integrated community-healthcare childhood obesity treatment
Intervention Description
The intervention will include nutrition and fitness programming at a local community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
Primary Outcome Measure Information:
Title
Eligibility
Description
Number of eligible patients
Time Frame
Baseline
Title
Referral
Description
Number of referred patients
Time Frame
Baseline
Title
Enrollment
Description
Number of patients referred who enroll
Time Frame
Baseline
Title
Attendance
Description
Number of participants present at each activity session
Time Frame
Through study completion, average of 1 year
Title
Fidelity
Description
Measured by program post-session evaluation survey
Time Frame
Through study completion, average of 1 year
Title
Change in quality of life
Description
Measured by Sizing me Up survey
Time Frame
Baseline, 6 months, 12 months
Title
Change in height
Time Frame
0 months, 3 months, 6 months, 12 months
Title
Change in nutrition habits (self report)
Time Frame
0 months, 3 months, 6 months, 12 months
Title
Food insecurity
Description
Measured by The Hunger Vital Sign food insecurity assessment
Time Frame
Baseline
Title
Change in cardiovascular fitness
Time Frame
0 months, 3 months, 6 months
Title
Patient satisfaction
Description
Measured by patient satisfaction survey
Time Frame
6 months
Title
Change in social cohesion
Description
Measured by social cohesion questionnaire
Time Frame
3 months, 6 months
Title
Change in weight
Time Frame
0 months, 3 months, 6 months, 12 months
Title
Change in activity (self report)
Time Frame
0 months, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Sampling: - Patients enrolled by their physician in the clinic-community program Inclusion: Child aged 2-17 years Child with age- and gender-specific BMI ≥ 85th percentile Exclusion: Inability to read and write in English or Spanish Parent with severe medical or mental health condition limiting ability to attend appointments Child with severe medical or mental health condition limiting ability to attend appointments or participate in behavioral therapies Parent and child live greater than 50 miles from the clinic and community center Plan to move out of state in the next 6 months, or plan to live in another state for 2 months or longer within the next 6 months (ex., summer vacation). Child with medical condition as cause of obesity (e.g., hypothyroidism, Cushing's Syndrome, Prader-Willi Syndrome, drug-induced obesity)
Facility Information:
Facility Name
First Health
City
Biscoe
State/Province
North Carolina
ZIP/Postal Code
27209
Country
United States
Facility Name
East Durham Children's Initiative
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Duke Healthy Lifestyles
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
Better Health
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28301
Country
United States
Facility Name
Goldsboro Parks and Recreation
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27530
Country
United States
Facility Name
Wake Med
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27601
Country
United States
Facility Name
Healthy Rowan
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34227849
Citation
Alexander E, Skinner A, Gaskin K, Jones J, Wong C, Loflin C, Fleming R, Howard J, Armstrong S, Neshteruk C. A Mixed-Methods Examination of Referral Processes to Clinic-Community Partnership Programs for the Treatment of Childhood Obesity. Child Obes. 2021 Dec;17(8):516-524. doi: 10.1089/chi.2020.0361. Epub 2021 Jul 5.
Results Reference
derived

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Active Recreation Through Community-Healthcare Engagement Study

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