Planned CORR: Planned Care for Obesity and Risk Reduction
Condition: Obesity; Cardiovascular Risk Factors
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The researchers propose a randomized controlled trial to evaluate how well an intervention,
      Planned Care for Obesity & Risk Reduction (Planned CORR), supports primary care treatment of
      obesity in adults with at least one cardiovascular risk factor (CVRF).
    

Detailed description: 
      The researchers propose a randomized controlled trial to evaluate how well an intervention,
      Planned Care for Obesity & Risk Reduction (Planned CORR), supports primary care treatment of
      obesity in adults with at least one cardiovascular risk factor (CVRF). We will assess how
      well it creates initial and sustained improvements in BMI and metabolic, anthropometric and
      behavioral outcomes in obese adults, age 25 to 70 who have one or more of the following
      CVRFs: hypertension, smoking or the metabolic syndrome. Planned CORR integrates intervention
      components based on behavior change theory with a delivery strategy based on the Chronic Care
      Model (Wagner et al, 2001; also called the "Planned Care Model") and is designed to
      incorporate intervention principles used successfully to treat obesity. Planned CORR is
      intended to be compatible with a variety of primary care settings including those with
      minimal resources to devote to patient education and where most obese adults receive their
      usual medical care. Study participants will be 380 women and men, age 25-70 who meet the
      entry criteria of obesity (Class I & II; BMI 30-45) plus one or more CVRFs. We anticipate
      that approximately 40% will be Hispanic and we will recruit an equal number of women and men
      and have powered the study to do analyses by gender. Planned CORR is a stepped care
      intervention that begins with computer-assisted assessment and tailored action planning,
      physician or nurse practitioner counseling, and an intensive "first step" of 4 months of
      lifestyle modification delivered via monthly in-person sessions and phone calls and weekly
      web or mail (based on preference) tutorials.CVRFs are managed concurrently according to
      recognized evidence-based protocols. Successive 4-month steps involve more, the same, or less
      intensive intervention depending on clinical response. The primary aim is to evaluate the
      effects at 12 & 24 months of Planned CORR on BMI when compared to enhanced usual care.
      Secondary aims will evaluate: CVRF outcomes; physiological, metabolic, behavioral, and
      psychosocial factors related to obesity and CVRFs; quality of life, depression and
      cost-effectiveness; and medical care quality, patient, provider & staff satisfaction, process
      measures relevant to implementation in primary care. Post study aims are to disseminate the
      knowledge gained from the intervention through conferences and publications, and to
      disseminate Planned CORR through proven channels of health care intervention dissemination.
    

Intervention name(s): Stepped Care
Intervention type(s): Behavioral
Intervention description(s): This group receives 2 years of a stepped care intervention including provider visits, health educator sessions, phone calls and mailings and availability of self management and group sessions, text messaging and a smoker's quit line.
Other intervention name(s): Healthy Road to a Healthy Heart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; weight management and cardiovascular risk factors