N/A
Completed N=363
Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study)
Source: ClinicalTrials.gov NCT00714168 ↗Enrolled (actual)
363
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Weight Loss — -8.1; -6.9 kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss |
-8.1; -6.9 | — |
| SECONDARY Physical Activity |
700; 841 | — |
| SECONDARY Energy Intake |
-511; -537 | — |
| SECONDARY Cardiovascular Fitness |
2.7; 2.7 | — |
| SECONDARY Body Composition |
-5.6; -5.0 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) between 25.0 and 39.9 kg/m2
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00714168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.