Active Recreation Through Community-Healthcare Engagement Study

NCT03246763 | Completed

• 1 other identifier: Pro00084070
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 7

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.

Conditions

Childhood Obesity; Quality of Life

Keywords

childhood obesity

Outcome Measures

Primary Outcomes (14)

• Eligibility

  Number of eligible patients

  Baseline

• Referral

  Number of referred patients

  Baseline

• Enrollment

  Number of patients referred who enroll

  Baseline

• Attendance

  Number of participants present at each activity session

  Through study completion, average of 1 year

• Fidelity

  Measured by program post-session evaluation survey

  Through study completion, average of 1 year

• Change in quality of life

  Measured by Sizing me Up survey

  Baseline, 6 months, 12 months

• Change in height

  0 months, 3 months, 6 months, 12 months

• Change in nutrition habits (self report)

  0 months, 3 months, 6 months, 12 months

• Food insecurity

  Measured by The Hunger Vital Sign food insecurity assessment

  Baseline

• Change in cardiovascular fitness

  0 months, 3 months, 6 months

• Patient satisfaction

  Measured by patient satisfaction survey

  6 months

• Change in social cohesion

  Measured by social cohesion questionnaire

  3 months, 6 months

• Change in weight

  0 months, 3 months, 6 months, 12 months

• Change in activity (self report)

  0 months, 3 months, 6 months, 12 months

Study Arms (4)

Durham County

EXPERIMENTAL

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.

Behavioral: Integrated community-healthcare childhood obesity treatment

Richmond/Montgomery Counties

EXPERIMENTAL

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.

Behavioral: Integrated community-healthcare childhood obesity treatment

TBD

EXPERIMENTAL

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.

Behavioral: Integrated community-healthcare childhood obesity treatment

To be determined

EXPERIMENTAL

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.

Behavioral: Integrated community-healthcare childhood obesity treatment

Interventions

Integrated community-healthcare childhood obesity treatment BEHAVIORAL

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.

Durham County; Richmond/Montgomery Counties; TBD; To be determined

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

Study Sites (7)

First Health

Biscoe, North Carolina, 27209, United States

Location

East Durham Children's Initiative

Durham, North Carolina, 27703, United States

Location

Duke Healthy Lifestyles

Durham, North Carolina, 27708, United States

Location

Better Health

Fayetteville, North Carolina, 28301, United States

Location

Goldsboro Parks and Recreation

Goldsboro, North Carolina, 27530, United States

Location

Wake Med

Raleigh, North Carolina, 27601, United States

Location

Healthy Rowan

Salisbury, North Carolina, 28144, United States

Location

Related Publications (1)

• 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.

  PMID: 34227849 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 11, 2017
• Study Start: June 7, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)