Clinical trial NCT00714168: Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study)
Official title: The Effect of a Stepped-care Approach to Long-term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss
Weight Control
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-07-14
Enrollment: 363
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Weight Loss
timeFrame: Measured at Month 18
Secondary outcomes:
measure: Physical Activity
timeFrame: Measured at Month 18
measure: Energy Intake
timeFrame: Measured at Month 18
measure: Cardiovascular Fitness
timeFrame: Measured at Month 18
measure: Body Composition
timeFrame: Measured at Month 18
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John M. Jakicic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Davis 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.
citation: Jakicic 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.