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Disseminating Effective Habits for Long-Term Weight Loss

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Disseminating Effective Habits for Long-term Weight Loss
Achieve Together website
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring weight loss, obesity, overweight

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Penn State College of Medicine General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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: Users will enter their weight and height, how well their plan for a healthy weight has been going, and clarify their goal weight. Users will answer questions about each habit they are using to lose weight 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. Users are encouraged to search for habits that have helped people of similar age and gender to themselves.

Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website. These participants will be a given a log where they can document weekly weight measurements (this part did not happen).

Outcomes

Primary Outcome Measures

Body weight
Weight will be measured using a calibrated, digital scale
Blood Pressure Control

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2008
Last Updated
October 19, 2015
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT00709501
Brief Title
Disseminating Effective Habits for Long-Term Weight Loss
Official Title
Disseminating Effective Habits for Long-Term Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
weight loss, obesity, overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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: Users will enter their weight and height, how well their plan for a healthy weight has been going, and clarify their goal weight. Users will answer questions about each habit they are using to lose weight 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. Users are encouraged to search for habits that have helped people of similar age and gender to themselves.
Arm Title
2
Arm Type
No Intervention
Arm Description
Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website. These participants will be a given a log where they can document weekly weight measurements (this part did not happen).
Intervention Type
Behavioral
Intervention Name(s)
Disseminating Effective Habits for Long-term Weight Loss
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Achieve Together website
Intervention Description
access to the Achieve Together website immediately (Arm 1) or delayed (Arm 2)
Primary Outcome Measure Information:
Title
Body weight
Description
Weight will be measured using a calibrated, digital scale
Time Frame
3 months
Title
Blood Pressure Control
Time Frame
3-Months
Secondary Outcome Measure Information:
Title
Physical Activity, using the International Physical Activity Questionnaire
Description
Results are still being analyzed
Time Frame
3 months
Title
Block 2005 FFQ for assessment of diet and physical activity
Time Frame
3 Months
Title
IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher N Sciamanna, M.D., MPH
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine General Clinical Research Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22099238
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.
Results Reference
derived

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Disseminating Effective Habits for Long-Term Weight Loss

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