Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00714168
First received: July 10, 2008
Last updated: November 16, 2010
Last verified: July 2009
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Standard Behavioral Weight Loss Program
Behavioral: Stepped-Care Weight Loss Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of a Stepped-care Approach to Long-term Weight Loss

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Weight loss [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  • Energy intake and eating behavior [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  • Psychosocial correlates [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  • Fitness [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 256
Study Start Date: March 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: 2
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.

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

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714168

Locations
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
Sponsors and Collaborators
Investigators
Principal Investigator: John M. Jakicic, PhD University of Pittsburgh
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John M. Jakicic, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00714168     History of Changes
Other Study ID Numbers: 584, HL 084400
Study First Received: July 10, 2008
Last Updated: November 16, 2010
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Weight Loss
Weight Control

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014