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Re-energize With Nutrition, Exercise and Weight Loss (RENEW)

This study has been completed.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00712127
First received: July 3, 2008
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

The purpose of this project is to establish a Center of Excellence in Research on Obesity that will focus on severe obesity. The prevalence of severe obesity (i.e., Class 2 and 3 obesity; body mass index > 35 kg/m2 and 40 kg/m2) is increasing more rapidly than is overweight and Class 1 obesity. Treatment guidelines for severe obesity are uncertain.

Three novel hypotheses regarding the pathogenesis of severe obesity will be tested: a) using non-invasive methods to measure energy expenditure; b) conducting an annotated lipomic search for bio-markers of impaired fat oxidation; and c) examining the role of obesity-induced inflammation as a cause for leptin resistance. Responses will also be measured following intervention with diet and activity.


Condition Intervention
Obesity
Other: Diet and Exercise
Other: Diet and Exercise-Delayed

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preventing Adverse Effects In Class II and Class III Obesity

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • This project addresses an important aspect of health disparity. The scientific inquiry as to causes of severe obesity seeks to determine if there is a differing metabolic disposition to obesity in AA compared to non-Hispanic White adults. [ Time Frame: Twelve months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish treatment guidelines for obesity. [ Time Frame: Twelve Months ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: June 2006
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet and Exercise
Diet and Exercise for Class II and Class III Obesity
Other: Diet and Exercise
The participants in this intervention will receive 12 months of weight loss through diet and exercise
Other Name: Diet and Exercise
Experimental: Diet and Exercise-Delayed
Diet and Exercise-Delayed for 6 months for Class II and Class III Obesity
Other: Diet and Exercise-Delayed
Participants in this intervention will receive six months of weight loss through diet followed by six months of diet and exercise
Other Name: Diet and Exercise-Delayed
No Intervention: Control
Normal weight, overweight and Class I obesity

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight
  • Age 30 to 55
  • Able to walk 3 to 4 blocks
  • Able to attend weekly meetings

Exclusion Criteria:

  • Do not have diabetes
  • Have not been in a weight loss program in the last year
  • Have never had bariatric surgery or stomach bypass surgery
  • Are not taking steroids or blood thinners
  • Have no history of heart disease, heart attacks, heart surgery
  • Have not had cancer in the past 5 years
  • Are not pregnant, or haven't been in the past six months
  • Are not currently nursing or planning to become pregnant in the next year
  • Are not planning to move out of the area in the next year
  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: NCT00712127

Locations
United States, Pennsylvania
Cheyney University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19319
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
University of Pennsylvania
Investigators
Principal Investigator: Bret H. Goodpaster, Ph.D. University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bret H. Goodpaster, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00712127     History of Changes
Other Study ID Numbers: 0608088
Study First Received: July 3, 2008
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Body Fat
Exercise
Metabolic syndrome
Obesity
Nutrition
Physical Activity
Weight Loss

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

ClinicalTrials.gov processed this record on November 20, 2014