Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study)
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Standard Behavioral Weight Loss Program; Stepped-Care Weight Loss Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss; Weight Control