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Sponsor study identifier
interventional
202
1 country
7
Study Start
June 7, 2018
Actual (reported)Primary Completion
May 1, 2020
Actual (reported)Study Completion
May 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 4, 2017
Actual (reported)August 11, 2017
Actual (reported)June 7, 2018
Actual (reported)May 1, 2020
Actual (reported)May 1, 2020
Actual (reported)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
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 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.
First Health
Biscoe, North Carolina, 27209, United States
East Durham Children's Initiative
Durham, North Carolina, 27703, United States
Duke Healthy Lifestyles
Durham, North Carolina, 27708, United States
Better Health
Fayetteville, North Carolina, 28301, United States
Goldsboro Parks and Recreation
Goldsboro, North Carolina, 27530, United States
Wake Med
Raleigh, North Carolina, 27601, United States
Healthy Rowan
Salisbury, North Carolina, 28144, United States
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.
202 participants (actual enrollment reported by the registry).
First Submitted
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
August 4, 2017
First Posted
August 11, 2017
Study Start
June 7, 2018
Actual (reported)Primary Completion
May 1, 2020
Actual (reported)Study Completion
May 1, 2020
Actual (reported)Last Updated
August 14, 2020
Record last verified: 2020-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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