Childhood ObesityARCHESNCT03246763
Active Recreation Through Community-Healthcare Engagement Study
A study testing Integrated community-healthcare childhood obesity treatment in people with Childhood Obesity and Quality of Life, run by Duke University at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Quality of Life
- What is being tested?
- Integrated community-healthcare childhood obesity treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Jun 2018to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Child aged 2-17 years
- Child with age- and gender-specific BMI ≥ 85th percentile
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
First Health
Biscoe, North Carolina, 27209
East Durham Children's Initiative
Durham, North Carolina, 27703
Duke Healthy Lifestyles
Durham, North Carolina, 27708
Better Health
Fayetteville, North Carolina, 28301
Goldsboro Parks and Recreation
Goldsboro, North Carolina, 27530
Wake Med
Raleigh, North Carolina, 27601
Healthy Rowan
Salisbury, North Carolina, 28144
About this 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.
Read the 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.
- Conditions
- Childhood Obesity, Quality of Life
- Being tested
- Integrated community-healthcare childhood obesity treatment
- Keywords
- childhood obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated community-healthcare childhood obesity treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Integrated community-healthcare childhood obesity treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility
Number of eligible patients
Measured: Baseline
Referral
Number of referred patients
Measured: Baseline
Enrollment
Number of patients referred who enroll
Measured: Baseline
Attendance
Number of participants present at each activity session
Measured: Through study completion, average of 1 year
Fidelity
Measured by program post-session evaluation survey
Measured: Through study completion, average of 1 year
Change in quality of life
Measured by Sizing me Up survey
Measured: Baseline, 6 months, 12 months
Change in height
Measured: 0 months, 3 months, 6 months, 12 months
Change in nutrition habits (self report)
Measured: 0 months, 3 months, 6 months, 12 months
Food insecurity
Measured by The Hunger Vital Sign food insecurity assessment
Measured: Baseline
Change in cardiovascular fitness
Measured: 0 months, 3 months, 6 months
Patient satisfaction
Measured by patient satisfaction survey
Measured: 6 months
Change in social cohesion
Measured by social cohesion questionnaire
Measured: 3 months, 6 months
Change in weight
Measured: 0 months, 3 months, 6 months, 12 months
Change in activity (self report)
Measured: 0 months, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start7 Jun 2018
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246763
- Sponsor's protocol ID
- Pro00084070
- Acronym
- ARCHES
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2017
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34227849
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Recreation Through Community-Healthcare Engagement Study
- ClinicalTrials.gov ID
- NCT03246763
- Acronym / sponsor ID
- ARCHES / Pro00084070
- Conditions
- Childhood Obesity, Quality of Life
- Keywords
- childhood obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Durham County | Experimental | Behavioral: Integrated community-healthcare childhood obesity treatmentThe 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. |
| Richmond/Montgomery Counties | Experimental | Behavioral: Integrated community-healthcare childhood obesity treatmentThe 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. |
| TBD | Experimental | Behavioral: Integrated community-healthcare childhood obesity treatmentThe 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. |
| To be determined | Experimental | Behavioral: Integrated community-healthcare childhood obesity treatmentThe 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Child aged 2-17 years
- Child with age- and gender-specific BMI ≥ 85th percentile
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated community-healthcare childhood obesity treatmentThe 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. | Behavioural | Durham County, Richmond/Montgomery Counties, TBD, To be determined |
Primary outcome
Eligibility
Time frame: Baseline
Number of eligible patients
Referral
Time frame: Baseline
Number of referred patients
Enrollment
Time frame: Baseline
Number of patients referred who enroll
Attendance
Time frame: Through study completion, average of 1 year
Number of participants present at each activity session
Fidelity
Time frame: Through study completion, average of 1 year
Measured by program post-session evaluation survey
Change in quality of life
Time frame: Baseline, 6 months, 12 months
Measured by Sizing me Up survey
Change in height
Time frame: 0 months, 3 months, 6 months, 12 months
Change in nutrition habits (self report)
Time frame: 0 months, 3 months, 6 months, 12 months
Food insecurity
Time frame: Baseline
Measured by The Hunger Vital Sign food insecurity assessment
Change in cardiovascular fitness
Time frame: 0 months, 3 months, 6 months
Patient satisfaction
Time frame: 6 months
Measured by patient satisfaction survey
Change in social cohesion
Time frame: 3 months, 6 months
Measured by social cohesion questionnaire
Change in weight
Time frame: 0 months, 3 months, 6 months, 12 months
Change in activity (self report)
Time frame: 0 months, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Derived from this study: PubMed 34227849Alexander 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated community-healthcare childhood obesity treatment in people with Childhood Obesity and Quality of Life, run by Duke University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.