NCT01134029

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

3.9 years

First QC Date

February 10, 2010

Last Update Submit

December 3, 2014

Conditions

ObesityCardiovascular Risk Factors

Keywords

obesityweight management and cardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

  • The primary aim is to evaluate the effects at 20 months of Planned CORR on BMI when compared to enhanced usual care.

    20 mo

Secondary Outcomes (3)

  • 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.

    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.

    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.

    12 months

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

Control Group

Stepped Care

EXPERIMENTAL

Intervention

Behavioral: Stepped Care

Interventions

Stepped CareBEHAVIORAL

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.

Also known as: Healthy Road to a Healthy Heart
Stepped Care

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD - La Jolla Professional Building

La Jolla, California, 92037-0811, United States

Location

Related Publications (1)

  • Liu J, Godino JG, Norman GJ, Hill L, Calfas K, Sallis JF, Arredondo E, Rock CL, Criqui M, Zhu SH, Griffiths K, Covin J, Dillon L, Patrick K. Planned care for obesity and cardiovascular risk reduction using a stepped-down approach: A randomized-controlled trial. Prev Med. 2018 Sep;114:223-231. doi: 10.1016/j.ypmed.2018.07.015. Epub 2018 Jul 25.

    PMID: 30055199DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin Patrick, MD, MS

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2010

First Posted

May 31, 2010

Study Start

November 1, 2009

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

US(1)