Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity
Abstract Background The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavio...
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| Format: | Article |
| Language: | English |
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BMC
2020-06-01
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| Series: | BMC Pediatrics |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12887-020-02190-x |
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| author | Sarah C. Armstrong McAllister Windom Nathan A. Bihlmeyer Jennifer S. Li Svati H. Shah Mary Story Nancy Zucker William E. Kraus Neha Pagidipati Eric Peterson Charlene Wong Manuela Wiedemeier Lauren Sibley Samuel I. Berchuck Peter Merrill Alexandra Zizzi Charles Sarria Holly K. Dressman John F. Rawls Asheley C. Skinner |
| author_facet | Sarah C. Armstrong McAllister Windom Nathan A. Bihlmeyer Jennifer S. Li Svati H. Shah Mary Story Nancy Zucker William E. Kraus Neha Pagidipati Eric Peterson Charlene Wong Manuela Wiedemeier Lauren Sibley Samuel I. Berchuck Peter Merrill Alexandra Zizzi Charles Sarria Holly K. Dressman John F. Rawls Asheley C. Skinner |
| author_sort | Sarah C. Armstrong |
| collection | DOAJ |
| description | Abstract Background The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems. Methods Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification. Discussion We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research—defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response. Clinical trial registration NCT03339440 . |
| first_indexed | 2024-12-14T12:19:07Z |
| format | Article |
| id | doaj.art-ee715c5ac71841a8a39d6b7228e72e94 |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-12-14T12:19:07Z |
| publishDate | 2020-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-ee715c5ac71841a8a39d6b7228e72e942022-12-21T23:01:34ZengBMCBMC Pediatrics1471-24312020-06-0120111210.1186/s12887-020-02190-xRationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesitySarah C. Armstrong0McAllister Windom1Nathan A. Bihlmeyer2Jennifer S. Li3Svati H. Shah4Mary Story5Nancy Zucker6William E. Kraus7Neha Pagidipati8Eric Peterson9Charlene Wong10Manuela Wiedemeier11Lauren Sibley12Samuel I. Berchuck13Peter Merrill14Alexandra Zizzi15Charles Sarria16Holly K. Dressman17John F. Rawls18Asheley C. Skinner19Department of Pediatrics, Duke UniversityDepartment of Pediatrics, Duke UniversityDuke Molecular Physiology Institute, Duke UniversityDepartment of Pediatrics, Duke UniversityDuke Molecular Physiology Institute, Duke UniversityDepartment of Family Medicine and Community Health, Duke UniversityDepartment of Psychiatry and Behavioral Sciences, Duke UniversityDepartment of Medicine, Duke UniversityDuke Clinical Research Institute, Duke UniversityDuke Clinical Research Institute, Duke UniversityDepartment of Pediatrics, Duke UniversityDuke Clinical Research Institute, Duke UniversityUniversity of North Carolina School of MedicineDepartment of Statistical Science, Duke UniversityDuke Clinical Research Institute, Duke UniversityDepartment of Pediatrics, Duke UniversityDepartment of Pediatrics, Duke UniversityDepartment of Molecular Genetics and Microbiology, Duke UniversityDepartment of Molecular Genetics and Microbiology, Duke UniversityDuke Clinical Research Institute, Duke UniversityAbstract Background The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems. Methods Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification. Discussion We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research—defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response. Clinical trial registration NCT03339440 .http://link.springer.com/article/10.1186/s12887-020-02190-xPediatricObesityCommunityChildrenAdolescentsCardiovascular |
| spellingShingle | Sarah C. Armstrong McAllister Windom Nathan A. Bihlmeyer Jennifer S. Li Svati H. Shah Mary Story Nancy Zucker William E. Kraus Neha Pagidipati Eric Peterson Charlene Wong Manuela Wiedemeier Lauren Sibley Samuel I. Berchuck Peter Merrill Alexandra Zizzi Charles Sarria Holly K. Dressman John F. Rawls Asheley C. Skinner Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity BMC Pediatrics Pediatric Obesity Community Children Adolescents Cardiovascular |
| title | Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity |
| title_full | Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity |
| title_fullStr | Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity |
| title_full_unstemmed | Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity |
| title_short | Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity |
| title_sort | rationale and design of hearts parks study protocol for a pragmatic randomized clinical trial of an integrated clinic community intervention to treat pediatric obesity |
| topic | Pediatric Obesity Community Children Adolescents Cardiovascular |
| url | http://link.springer.com/article/10.1186/s12887-020-02190-x |
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