Planned CORR: Planned Care for Obesity and Risk Reduction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kevin Patrick, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01134029
First received: February 10, 2010
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention
Obesity
Cardiovascular Risk Factors
Behavioral: Stepped Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Planned CORR: Planned Care for Obesity and Risk Reduction

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • The primary aim is to evaluate the effects at 20 months of Planned CORR on BMI when compared to enhanced usual care. [ Time Frame: 20 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CVRF outcomes; physiological, metabolic, behavioral, and psychosocial factors related to obesity and CVRFs; quality of life, depression, cost-effectiveness; and medical care quality, patient, provider & staff satisfaction, and process measures. [ Time Frame: 20 mo ] [ Designated as safety issue: No ]
  • CVRF outcomes; physiological, metabolic, behavioral, and psychosocial factors related to obesity and CVRFs; quality of life, depression, cost-effectiveness; and medical care quality, patient, provider & staff satisfaction, and process measures. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • CVRF outcomes; physiological, metabolic, behavioral, and psychosocial factors related to obesity and CVRFs; quality of life, depression, cost-effectiveness; and medical care quality, patient, provider & staff satisfaction, and process measures. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: November 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Enhanced Usual Care
Control Group
Experimental: Stepped Care
Intervention
Behavioral: Stepped Care
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 Name: Healthy Road to a Healthy Heart

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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 25 - 70
  • English or Spanish Speaking
  • Has transportation to get to follow-up appointments
  • Has a functional and stable telephone number
  • Lives in San Diego, maintains a permanent address, and plans on staying in San Diego for the next 2 years
  • BMI of 30-45
  • Have at least ONE of the following risk factors:

    • Hypertension
    • Smoking
    • Stabilized type II diabetes (Hemoglobin A1c Level <8.5);
    • Metabolic syndrome (defined as the presence of at least 3 of the following 5 factors: 1) elevated waist circumference: men: > 40 inches women: > 35 inches; 2) elevated triglycerides: >_150 mg/dL; 3) reduced HDL cholesterol: men < 40 mg/dL, women < 50 mg/dL; 4) elevated blood pressure: >130/85 mm.Hg; 5) Elevated fasting glucose (100-125 mg/dL).
  • Able to participate in moderate physical activity

Exclusion Criteria:

  • Has not had any form of bariatric/weight loss surgery (eg, gastric bypass, lap band) & does not intend to within 2 yrs.
  • Does not have a history of substance abuse in the last 2 years (including amphetamines, opiates, and alcohol abuse) or other severe/unstable psychiatric disorder that would impair compliance with the study protocol (e.g. unstable depression, bipolar, schizophrenia).
  • Is not pregnant or does not intend to become pregnant during the 2-year study period.
  • Is not currently taking weight-altering medications (e.g. Sibutramine (Meridia), Orlistat (Xenical, Alli)), and has not taken them in at least 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134029

Locations
United States, California
UCSD - La Jolla Professional Building
La Jolla, California, United States, 92037-0811
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kevin Patrick, MD, MS UCSD
  More Information

Additional Information:
No publications provided

Responsible Party: Kevin Patrick, MD, MS, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01134029     History of Changes
Other Study ID Numbers: HL089444, UCSD# 2007-4401
Study First Received: February 10, 2010
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
obesity
weight management and cardiovascular risk factors

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014