Disseminating Effective Habits for Long-Term Weight Loss

Not Applicable

Completed

• Conditions: Overweight; Obesity

• Registration Number: NCT00709501
• Lead Sponsor: Penn State University

Brief Summary

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

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 helps 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.

Study Timeline

• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-03
• Study Start: 2009-07
• Primary Completion: 2010-02
• Study Completion: 2010-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 21-65
• BMI 27-40 kg/m2
• Fluently speaks and reads 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
• Participant in NCT00377208

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
  • Cancer (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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight	3 months	Weight will be measured using a calibrated, digital scale
Blood Pressure Control	3-Months

Secondary Outcome Measures

Name	Time	Method
Physical Activity, using the International Physical Activity Questionnaire	3 months	Results are still being analyzed
Block 2005 FFQ for assessment of diet and physical activity	3 Months
IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific	3 Months

Trial Locations

Locations (1)

Penn State College of Medicine General Clinical Research Center; 🇺🇸 Hershey, Pennsylvania, United States