Disseminating Effective Habits for Long-Term Weight Loss

Obesity Clinical Trial

Official title:

Disseminating Effective Habits for Long-Term Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709501
• Other study ID #: 28160
• Status: Completed
• Phase: N/A
• First received: July 1, 2008
• Last updated: October 19, 2015
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2015
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

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).
• Achieve Together website
access to the Achieve Together website immediately (Arm 1) or delayed (Arm 2)

Locations

Country	Name	City	State
United States	Penn State College of Medicine General Clinical Research Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Weight will be measured using a calibrated, digital scale	3 months	No
Primary	Blood Pressure Control		3-Months	No
Secondary	Physical Activity, using the International Physical Activity Questionnaire	Results are still being analyzed	3 months	No
Secondary	Block 2005 FFQ for assessment of diet and physical activity		3 Months	No
Secondary	IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific		3 Months	No