Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study) (Step-Up)
|ClinicalTrials.gov Identifier: NCT00714168|
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
|Condition or disease||Intervention/treatment|
|Obesity||Behavioral: Standard Behavioral Weight Loss Program Behavioral: Stepped-Care Weight Loss Program|
Obesity can lead to many serious health conditions, including high blood pressure, diabetes, heart disease, and stroke. It is estimated that more than 65% of adults in the United States are overweight or obese, which is a significant increase over the past two to three decades. Although numerous studies have identified successful programs that help people achieve initial weight loss, few weight loss programs have shown promise for long-term success. Research has shown that a weight loss program in which there is continued contact between the program leader and the participant may improve long-term weight loss outcomes. In addition, a stepped-care approach to weight loss, in which contact between the participant and program leader increases when needed to achieve the next weight loss goal, may be beneficial. This study will examine whether a long-term weight loss program delivered in a stepped-care manner results in greater weight loss than does a standard behavioral weight loss program. Study researchers will also evaluate the cost effectiveness of both programs.
Participants in this 18-month study will be randomly assigned to either a standard behavioral weight loss program or a stepped-care weight loss program. Participants in the standard behavioral weight loss program will attend group meetings once a week for Months 1 to 6, every other week for Months 7 to 12, and once a month for Months 13 to 18. The group meetings will focus on modifying eating habits and physical activity behaviors to improve weight loss. Participants in the stepped-care weight loss program will take part in a combination of treatments, whose timing and intensity will depend on the participants' abilities to achieve predetermined weight loss goals. These treatments may include attending monthly group meetings, receiving weekly weight loss information in the mail, receiving telephone calls from study staff to discuss weight loss behaviors, taking part in individual sessions with study staff to discuss weight loss, and receiving meal replacements (e.g., Slim Fast shakes, meal bars). Participants who do not achieve their weight loss goals at select time points during the study will receive more individual attention from study staff. All participants will follow a diet that focuses on decreasing calories and fat. They will be instructed to follow a walking program 5 days a week and to keep a food and exercise diary. Participants will also have access to a Web site that will include a study calendar and information about how to change eating and exercise behaviors; the use of this Web site is optional.
Study visits will occur at baseline and Months 3, 6, 9, 12, 15, and 18. At each visit, participants' weight and height will be measured, and participants will complete questionnaires about their mood, general health, and exercise and diet habits. At baseline and Months 6, 12, and 18, participants will undergo measurements of blood pressure, fat, muscle, and waist and hip circumferences. Also at these times, physical fitness levels will be measured through a treadmill walking activity, during which an electrocardiogram (ECG) will record heart rate. For 7 consecutive days at baseline and Months 6, 12, and 18, participants will wear an activity monitor to measure physical activity levels.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||363 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of a Stepped-care Approach to Long-term Weight Loss|
|Study Start Date :||March 2008|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Active Comparator: 1
Participants will take part in a standard behavioral weight loss program.
Behavioral: Standard Behavioral Weight Loss Program
This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
Participants will take part in a stepped-care weight loss program.
Behavioral: Stepped-Care Weight Loss Program
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.
- Weight Loss [ Time Frame: Measured at Month 18 ]Change in Weight from Baseline
- Physical Activity [ Time Frame: Measured at Month 18 ]Change in Physical Activity from Baseline
- Energy Intake [ Time Frame: Measured at Month 18 ]Change in Energy Intake from Baseline
- Cardiovascular Fitness [ Time Frame: Measured at Month 18 ]Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline
- Body Composition [ Time Frame: Measured at Month 18 ]Change in Percent Body Fat from Baseline
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714168
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15203|
|Principal Investigator:||John M. Jakicic, PhD||University of Pittsburgh|