Re-energize With Nutrition, Exercise and Weight Loss
RENEW
Preventing Adverse Effects In Class II and Class III Obesity
1 other identifier
interventional
310
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jun 2006
Longer than P75 for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 3, 2008
CompletedFirst Posted
Study publicly available on registry
July 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJuly 31, 2017
July 1, 2017
3.8 years
July 3, 2008
July 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Twelve months
Secondary Outcomes (1)
To establish treatment guidelines for obesity.
Twelve Months
Study Arms (3)
Diet and Exercise
EXPERIMENTALDiet and Exercise for Class II and Class III Obesity
Diet and Exercise-Delayed
EXPERIMENTALDiet and Exercise-Delayed for 6 months for Class II and Class III Obesity
Control
NO INTERVENTIONNormal weight, overweight and Class I obesity
Interventions
The participants in this intervention will receive 12 months of weight loss through diet and exercise
Participants in this intervention will receive six months of weight loss through diet followed by six months of diet and exercise
Eligibility Criteria
You may qualify if:
- Overweight
- Age 30 to 55
- Able to walk 3 to 4 blocks
- Able to attend weekly meetings
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- University of Pennsylvaniacollaborator
Study Sites (2)
Cheyney University of Pennsylvania
Philadelphia, Pennsylvania, 19319, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (4)
Fu CP, Ali H, Rachakonda VP, Oczypok EA, DeLany JP, Kershaw EE. The ZJU index is a powerful surrogate marker for NAFLD in severely obese North American women. PLoS One. 2019 Nov 26;14(11):e0224942. doi: 10.1371/journal.pone.0224942. eCollection 2019.
PMID: 31770380DERIVEDRachakonda V, Wills R, DeLany JP, Kershaw EE, Behari J. Differential Impact of Weight Loss on Nonalcoholic Fatty Liver Resolution in a North American Cohort with Obesity. Obesity (Silver Spring). 2017 Aug;25(8):1360-1368. doi: 10.1002/oby.21890. Epub 2017 Jun 12.
PMID: 28605159DERIVEDHames KC, Coen PM, King WC, Anthony SJ, Stefanovic-Racic M, Toledo FG, Lowery JB, Helbling NL, Dube JJ, DeLany JP, Jakicic JM, Goodpaster BH. Resting and exercise energy metabolism in weight-reduced adults with severe obesity. Obesity (Silver Spring). 2016 Jun;24(6):1290-8. doi: 10.1002/oby.21501. Epub 2016 Apr 30.
PMID: 27129892DERIVEDGoodpaster BH, Delany JP, Otto AD, Kuller L, Vockley J, South-Paul JE, Thomas SB, Brown J, McTigue K, Hames KC, Lang W, Jakicic JM. Effects of diet and physical activity interventions on weight loss and cardiometabolic risk factors in severely obese adults: a randomized trial. JAMA. 2010 Oct 27;304(16):1795-802. doi: 10.1001/jama.2010.1505. Epub 2010 Oct 9.
PMID: 20935337DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bret H. Goodpaster, Ph.D.
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 3, 2008
First Posted
July 9, 2008
Study Start
June 1, 2006
Primary Completion
March 1, 2010
Study Completion
May 1, 2010
Last Updated
July 31, 2017
Record last verified: 2017-07