Planned CORR: Planned Care for Obesity and Risk Reduction (Planned CORR)

December 3, 2014 updated by: Kevin Patrick, MD, MS, University of California, San Diego
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037-0811
        • UCSD - La Jolla Professional Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Healthy Road to a Healthy Heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
20 mo

Secondary Outcome Measures

Outcome Measure
Time Frame
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
20 mo
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
8 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

February 10, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (Estimate)

May 31, 2010

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL089444
  • UCSD# 2007-4401 (Other Identifier: UCSD)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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