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Completed

NCT Number: NCT03246763

Active Recreation Through Community-Healthcare Engagement Study

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Quality of Life Signs and Symptoms

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Health, Biscoe, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Eligibility

    Time frame: Baseline

    Number of eligible patients

  2. Referral

    Time frame: Baseline

    Number of referred patients

  3. Enrollment

    Time frame: Baseline

    Number of patients referred who enroll

  4. Attendance

    Time frame: Through study completion, average of 1 year

    Number of participants present at each activity session

  5. Fidelity

    Time frame: Through study completion, average of 1 year

    Measured by program post-session evaluation survey

  6. Change in quality of life

    Time frame: Baseline, 6 months, 12 months

    Measured by Sizing me Up survey

  7. Change in height

    Time frame: 0 months, 3 months, 6 months, 12 months

  8. Change in nutrition habits (self report)

    Time frame: 0 months, 3 months, 6 months, 12 months

  9. Food insecurity

    Time frame: Baseline

    Measured by The Hunger Vital Sign food insecurity assessment

  10. Change in cardiovascular fitness

    Time frame: 0 months, 3 months, 6 months

  11. Patient satisfaction

    Time frame: 6 months

    Measured by patient satisfaction survey

  12. Change in social cohesion

    Time frame: 3 months, 6 months

    Measured by social cohesion questionnaire

  13. Change in weight

    Time frame: 0 months, 3 months, 6 months, 12 months

  14. Change in activity (self report)

    Time frame: 0 months, 3 months, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: ARCHES

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2017
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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