Clinical trial NCT00709501: Disseminating Effective Habits for Long-Term Weight Loss
Official title: Disseminating Effective Habits for Long-Term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: weight loss
obesity
overweight
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2008-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Body weight
timeFrame: 3 months
measure: Blood Pressure Control
timeFrame: 3-Months
Secondary outcomes:
measure: Physical Activity, using the International Physical Activity Questionnaire
timeFrame: 3 months
measure: Block 2005 FFQ for assessment of diet and physical activity
timeFrame: 3 Months
measure: IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific
timeFrame: 3 Months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine General Clinical Research Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Christopher N Sciamanna, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraschnewski JL, Stuckey HL, Rovniak LS, Lehman EB, Reddy M, Poger JM, Kephart DK, Coups EJ, Sciamanna CN. Efficacy of a weight-loss website based on positive deviance. A randomized trial. Am J Prev Med. 2011 Dec;41(6):610-4. doi: 10.1016/j.amepre.2011.08.012.