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Disseminating Effective Habits for Long-Term Weight Loss
This study is not yet open for participant recruitment.
Verified by Penn State University, May 2008
Sponsored by: Penn State University
Information provided by: Penn State University
ClinicalTrials.gov Identifier: NCT00709501
  Purpose

The purpose of the study is to determine whether using a web-based weight loss website can help overweight individuals lose weight.


Condition Intervention
Overweight
Obesity
Behavioral: Disseminating Effective Habits for Long-term Weight Loss

MedlinePlus related topics: Obesity Weight Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Body weight, which will be measured using a calibrated, digital scale. [ Time Frame: Body weight will be assessed at 0 and 3 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical Activity, using the International Physical Activity Questionnaire [ Time Frame: Questionnaire given at 0 and 3 months ] [ Designated as safety issue: No ]
  • Caloric intake, measured using the National Cancer Institute's Diet History Questionnaire [ Time Frame: Questionnaire given at 0 and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental

Participants in the intervention condition are encouraged to access the Achieve Together website at least once each week. During each login, the following activities will occur:

  1. Users will enter their weight and height, how well their plan for a healthy weight has been going, and clarify their goal weight.
  2. Users will answer questions about each habit they are using to lose weight
  3. Users will receive automated feedback about each habit and will be encouraged to change or delete habits that are being used but not helpful, more consistently use habits that are helpful but not used being used and to continue to use habits that are helpful and being used consistently.
  4. Users are encouraged to search for habits that have helped people of similar age and gender to themselves.
Behavioral: Disseminating Effective Habits for Long-term Weight Loss
Comparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website).
2: No Intervention
Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website. These participants will be given a log where they can document weekly weight measurements.
Behavioral: Disseminating Effective Habits for Long-term Weight Loss
Comparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website).

Detailed Description:

Overweight and obesity are serious threats to public health. Over the last 20 years, the percentage of overweight and obese Americans, as well as the rate of diabetes, have grown tremendously (Cowie, Rust et al. 2006).

Few individuals are successful at long-term weight loss. Long-term weight loss is an elusive, yet sought after goal for many Americans (2000). Fewer than 5% of adults are successful in maintaining a 20 pound weight loss for at least 2 years (Klem, Wing et al. 1997). While medications can be effective, they produce only small amounts of weight loss, carry a significant cost and appear to be effective only while being taken (2000). Surgery is an effective option, though the procedure has tremendous costs and potential complications (2000). This points to the need for innovative and effective treatments that help individuals over the longer-term.

Some, but not all, web-based treatments for weight loss have been shown to be effective. A recent study by Tate and colleagues showed that individuals who received counseling emails from a human or automated emails from a computer lost more weight than individuals who received neither(7.3 kg lost v. 4.9 kg and 2.6 kg, respectively) (Tate, Jackvony et al. 2006) (Tate, Jackvony et al. 2003). The feedback in the emails was based on diet and physical activity information that the individuals entered online. Dr. Harvey-Berino and colleagues has shown that social support delivered via the Internet can help weight loss efforts to the same degree as in person support (Harvey-Berino, Pintauro et al. 2004). Other studies have been mixed in their effects (Williamson, Walden et al. 2006) (Gold, Burke et al. 2007) (Wing, Tate et al. 2006), though there has generally been an effect from human feedback delivered via a computer. Other than the recent study by Tate and colleagues, no fully automated website has been effective at producing weight loss. It is our belief that fully automated systems are needed to meet the needs, in a cost-effective manner, of the 80 million overweight Americans who will need life-long help in losing weight and in maintaining their weight loss.

During an earlier phase of the study, 50 in-depth interviews were conducted with individuals who have been successful at losing weight and keeping it off. These individuals were asked specifically about which habits they use to maintain their weight loss, how these habits are implemented and how barriers to using these habits are overcome. These interviews were transcribed and the data entered into a website, to be used as part of the intervention to be tested in this clinical trial.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21-65
  • BMI 27-40kg/m2
  • Fluently speak and read English
  • Access to the Internet at home or at work
  • Valid email address
  • Access to a scale for weekly weigh-ins
  • Agree not to seek additional weight loss treatment
  • Agree to come back regardless of amount of weight lost

Exclusion Criteria:

  • Current, planned, or previous pregnancy within 12 months
  • Planned or past weight loss surgery
  • Recent weight loss of >= 15 lbs. in the past 6 months
  • History of:

    • Myocardial infarction
    • Stroke
    • Type 1 and Type 2 diabetes
    • Unstable angina
    • Congestive heart failure
    • Inability to exercise due to severe arthritis or other musculoskeletal problems
    • Caner (except non-melanoma skin cancer)
  • Evidence of severe cognitive impairment or major psychiatric illness
  • Plans to move in the next 6 months
  • Answering yes to any question on the Physical Activity Readiness Questionnaire (PAR-Q)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709501

Contacts
Contact: Christopher N Sciamanna, M.D., MPH 717-531-8161 cns10@psu.edu
Contact: Jolene L Esposito, B.S. 717-531-0003 ext 287515 jle224@psu.edu

Locations
United States, Pennsylvania
Penn State College of Medicine General Clinical Research Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Christopher N Sciamanna, M.D., MPH Penn State College of Medicine
  More Information

Responsible Party: Penn State College of Medicine ( Christopher N. Sciamanna, M.D., MPH )
Study ID Numbers: 28160
Study First Received: July 1, 2008
Last Updated: July 1, 2008
ClinicalTrials.gov Identifier: NCT00709501  
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
weight loss
obesity
overweight

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 14, 2009