Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study)
Step-Up
The Effect of a Stepped-care Approach to Long-term Weight Loss
3 other identifiers
interventional
363
1 country
2
Brief Summary
The number of overweight and obese adults in the United States is increasing at a rapid rate. A "stepped-care" weight loss program, which at key times increases the frequency of contact between an individual trying to lose weight and the program staff, may be beneficial for achieving long-term weight loss. This study will compare a standard behavioral weight loss program with a "stepped-care" weight loss program in their abilities to help people who are overweight or obese to lose weight.
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 Mar 2008
Typical duration 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
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 10, 2008
CompletedFirst Posted
Study publicly available on registry
July 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
February 1, 2016
CompletedFebruary 1, 2016
December 1, 2015
3.5 years
July 10, 2008
January 6, 2013
December 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Loss
Change in Weight from Baseline
Measured at Month 18
Secondary Outcomes (4)
Physical Activity
Measured at Month 18
Energy Intake
Measured at Month 18
Cardiovascular Fitness
Measured at Month 18
Body Composition
Measured at Month 18
Study Arms (2)
1
ACTIVE COMPARATORParticipants will take part in a standard behavioral weight loss program.
2
EXPERIMENTALParticipants will take part in a stepped-care weight loss program.
Interventions
This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 25.0 and 39.9 kg/m2
You may not qualify if:
- Reports losing more than 5% of current body weight in the 6 months before study entry
- Participated in a research project involving weight loss or physical activity in the 6 months before study entry
- Pregnant during the 6 months before study entry, currently breastfeeding, or planning to become pregnant in the 18 months after study entry
- Current treatment for any medical condition that could affect body weight (e.g., diabetes mellitus, cancer)
- History of heart attack or heart surgery, including bypass or angioplasty
- Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers)
- Currently taking medication that could affect metabolism or change body weight (e.g., synthroid)
- Currently being treated for psychological issues or has taken psychotropic medications in the 6 months before study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15203, United States
Related Publications (3)
Creasy SA, Lang W, Tate DF, Davis KK, Jakicic JM. Pattern of Daily Steps is Associated with Weight Loss: Secondary Analysis from the Step-Up Randomized Trial. Obesity (Silver Spring). 2018 Jun;26(6):977-984. doi: 10.1002/oby.22171. Epub 2018 Apr 6.
PMID: 29633583DERIVEDDavis KK, Tate DF, Lang W, Neiberg RH, Polzien K, Rickman AD, Erickson K, Jakicic JM. Racial Differences in Weight Loss Among Adults in a Behavioral Weight Loss Intervention: Role of Diet and Physical Activity. J Phys Act Health. 2015 Dec;12(12):1558-66. doi: 10.1123/jpah.2014-0243. Epub 2015 Mar 5.
PMID: 25742122DERIVEDJakicic JM, Tate DF, Lang W, Davis KK, Polzien K, Rickman AD, Erickson K, Neiberg RH, Finkelstein EA. Effect of a stepped-care intervention approach on weight loss in adults: a randomized clinical trial. JAMA. 2012 Jun 27;307(24):2617-26. doi: 10.1001/jama.2012.6866.
PMID: 22735431DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was not designed to test for weight loss equivalency between conditions. This study is unable to determined if an alternative intensity or frequency of intervention steps would be more or less effective for weight loss.
Results Point of Contact
- Title
- John M. Jakicic, PhD
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
John M. Jakicic, PhD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair
Study Record Dates
First Submitted
July 10, 2008
First Posted
July 14, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
February 1, 2016
Results First Posted
February 1, 2016
Record last verified: 2015-12