Randomized Controlled Trial

. 2018 Apr:67:16-22.

doi: 10.1016/j.cct.2018.01.002. Epub 2018 Jan 10.

Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial

Lauren Fiechtner¹, Meghan Perkins², Vincent Biggs³, Nancy Langhans⁴, Mona Sharifi⁵, Giselle O'Connor⁶, Sarah Price⁷, Joseph Locascio⁸, Karen Kuhlthau⁹, Jo-Ann Kwass¹⁰, Candace Nelson¹¹, Thomas Land¹², Matt Longjohn¹³, Valerie Lawson¹⁴, Katherine Hohman¹⁵, Elsie M Taveras¹⁶

Affiliations

¹ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA; Department of Gastroenterology and Nutrition, MassGeneral Hospital for Children, 175 Cambridge St., 5th floor, Boston, MA 02114, USA. Electronic address: Lfiechtner@partners.org.
² Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA. Electronic address: meperkins@mgh.harvard.edu.
³ Holyoke Community Health Center, Department of Pediatrics, 230 Maple St., Holyoke, MA 01040, USA. Electronic address: Vinny.Biggs@hhcinc.org.
⁴ Greater New Bedford Community Health Center, Department of Pediatrics, 874 Purchase St., New Bedford, MA 02740, USA. Electronic address: nlanghans@gnbchc.org.
⁵ Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, 333 Cedar Street, PO Box 208064, New Haven, CT 06520, USA. Electronic address: mona.sharifi@yale.edu.
⁶ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA. Electronic address: gmoconnor@mgh.harvard.edu.
⁷ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA. Electronic address: snprice@partners.org.
⁸ Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. Electronic address: jlocascio@mgh.harvard.edu.
⁹ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA. Electronic address: kkuhlthau@mgh.harvard.edu.
¹⁰ Bureau of Community Health and Prevention, Massachusetts Department of Public Health, 250 Washington Street, Boston, MA 02108, USA. Electronic address: jo-ann.kwass@state.ma.us.
¹¹ Bureau of Community Health and Prevention, Massachusetts Department of Public Health, 250 Washington Street, Boston, MA 02108, USA. Electronic address: Candace.Nelson@MassMail.State.MA.US.
¹² Office of Data Management and Outcomes Assessment, Massachusetts Department of Public Health, 250 Washington Street, Boston, MA 02108, USA. Electronic address: Thomas.Land@MassMail.State.MA.US.
¹³ YMCA of the USA, 101 N Wacker Drive, Chicago, IL 60606, USA. Electronic address: matt.longjohn@ymca.net.
¹⁴ YMCA of the USA, 101 N Wacker Drive, Chicago, IL 60606, USA. Electronic address: Valerie.lawson@ymca.net.
¹⁵ YMCA of the USA, 101 N Wacker Drive, Chicago, IL 60606, USA. Electronic address: katherine.hohman@ymca.net.
¹⁶ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA; Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave., Boston, MA 02115, USA. Electronic address: elsie.taveras@mgh.harvard.edu.

PMID: 29330083
PMCID: PMC5871582
DOI: 10.1016/j.cct.2018.01.002

Randomized Controlled Trial

Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial

Lauren Fiechtner et al. Contemp Clin Trials. 2018 Apr.

. 2018 Apr:67:16-22.

doi: 10.1016/j.cct.2018.01.002. Epub 2018 Jan 10.

Authors

Affiliations

¹ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA; Department of Gastroenterology and Nutrition, MassGeneral Hospital for Children, 175 Cambridge St., 5th floor, Boston, MA 02114, USA. Electronic address: Lfiechtner@partners.org.
² Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA. Electronic address: meperkins@mgh.harvard.edu.
³ Holyoke Community Health Center, Department of Pediatrics, 230 Maple St., Holyoke, MA 01040, USA. Electronic address: Vinny.Biggs@hhcinc.org.
⁴ Greater New Bedford Community Health Center, Department of Pediatrics, 874 Purchase St., New Bedford, MA 02740, USA. Electronic address: nlanghans@gnbchc.org.
⁵ Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, 333 Cedar Street, PO Box 208064, New Haven, CT 06520, USA. Electronic address: mona.sharifi@yale.edu.
⁶ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA. Electronic address: gmoconnor@mgh.harvard.edu.
⁷ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA. Electronic address: snprice@partners.org.
⁸ Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. Electronic address: jlocascio@mgh.harvard.edu.
⁹ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA. Electronic address: kkuhlthau@mgh.harvard.edu.
¹⁰ Bureau of Community Health and Prevention, Massachusetts Department of Public Health, 250 Washington Street, Boston, MA 02108, USA. Electronic address: jo-ann.kwass@state.ma.us.
¹¹ Bureau of Community Health and Prevention, Massachusetts Department of Public Health, 250 Washington Street, Boston, MA 02108, USA. Electronic address: Candace.Nelson@MassMail.State.MA.US.
¹² Office of Data Management and Outcomes Assessment, Massachusetts Department of Public Health, 250 Washington Street, Boston, MA 02108, USA. Electronic address: Thomas.Land@MassMail.State.MA.US.
¹³ YMCA of the USA, 101 N Wacker Drive, Chicago, IL 60606, USA. Electronic address: matt.longjohn@ymca.net.
¹⁴ YMCA of the USA, 101 N Wacker Drive, Chicago, IL 60606, USA. Electronic address: Valerie.lawson@ymca.net.
¹⁵ YMCA of the USA, 101 N Wacker Drive, Chicago, IL 60606, USA. Electronic address: katherine.hohman@ymca.net.
¹⁶ Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA 02114, USA; Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave., Boston, MA 02115, USA. Electronic address: elsie.taveras@mgh.harvard.edu.

PMID: 29330083
PMCID: PMC5871582
DOI: 10.1016/j.cct.2018.01.002

Abstract

Background: Recent studies have demonstrated the effectiveness of family-centered, pediatric weight management programs in reducing childhood obesity. Yet, programs to optimize the care of low-income children with obesity are needed. We sought to examine the comparative effectiveness of two, potentially scalable pediatric weight management programs delivered to low-income children in a clinical or community setting.

Materials and methods: The Clinic and Community Approaches to Healthy Weight Trial is a randomized trial in two communities in Massachusetts that serve a large population of low-income children and families. The two-arm trial compares the effects of a pediatric weight management program delivered in the Healthy Weight Clinics of two federally qualified health centers (FQHC) to the Healthy Weight and Your Child programs delivered in two YMCAs. Eligible children are 6 to 12 years old with a body mass index (BMI) ≥ 85th percentile seen in primary care at the two FQHCs. Both programs are one-year in duration and have at least 30 contact hours throughout the year. Measures are collected at baseline, 6 months, and 1 year. The main outcome is 1-year change in BMI (kg/m²) and percent change of the 95th percentile (%BMIp₉₅).

Conclusion: The Clinic and Community Approaches to Healthy Weight Trial seeks to 1) examine the comparative effects of a clinical and community based intervention in improving childhood obesity, and 2) inform the care of >7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.

Trial registration: ClinicalTrials.gov NCT03012126.

Keywords: Childhood obesity treatment; Clinical and community approaches; Randomized controlled trial.

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Conflict of interest statement

Competing Interests: The authors have no competing interests to declare.

Figures

**Figure 1**
Logic Model of the Clinic and Community Approaches to Healthy Weight (MA-CORD 2.0) Trial

**Figure 2**
Study Design and intervention components of the Clinic and Community Approaches to Healthy Weight (MA-CORD 2.0) Trial

**Figure 3**
Clinic and Community Approaches to Healthy Weight (MA-CORD 2.0) Randomized Controlled Trial Planned Participant Flow Chart

See this image and copyright information in PMC

References

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Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial

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Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial

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