Clinical trial NCT01043718: Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study
Official title: Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Keywords: Obesity
Internet
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Milton S. Hershey Medical Center
name: United States Department of Defense
First posted: 2010-01-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hershey Medical Center and the University of Pittsburgh are doing a research study to help meet the needs of the adult population at risk for diabetes and heart disease. This study will provide a web-based program that aims to help participants to develop healthier eating habits, lose weight and become more physically active. The Internet-based materials will teach participants about healthy eating and physical activity and will ask them to incorporate the information they learn into their daily lives.

The purpose of this study is to evaluate the effectiveness of online lifestyle change programs to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and cardiovascular disease (CVD).


Eligibility criteria: Please note: Only individuals who receive primary care at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA, are eligible for this study.

Inclusion Criteria:

* Age between 18 and 80 years old
* Obese based on World Health Organization criteria (BMI\>30kg/m2)
* Receiving primary care from and referred by a provider at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA
* Able to understand and sign an informed consent document
* Able to communicate with the investigator and understand the requirements of this study

Exclusion Criteria

* Primary care provider determines that the individual is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
* Primary care provider determines that the individual has inadequate cognitive function to participate in either active intervention curricula
* Women who are pregnant, who are planning to become pregnant in the next two years, or who become pregnant during the study
* Women who are breastfeeding
* Prisoners
* Children
* Individuals who are planning to have bariatric surgery or who have had bariatric surgery in the past two years
* Individuals with uncontrolled hypertension (systolic blood pressure (SBP) \>165, diastolic blood pressure (DBP) \>100)
* Individuals with an edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, end- stage renal disease, or ascites),
* Individuals already using weight loss therapy
* Individuals with an inability to learn adequately from English language audio-taped materials
* Individuals with a lack of high-speed Internet access (Internet access will be based on participant perception; for example, participants could use computers belonging to friends, relatives, or libraries if they feel that they can access them regularly)
* Individuals without access to a scale
* Individuals unable to attend an Orientation session at Hershey Medical Center in Hershey, PA

Primary outcomes:
measure: Change in body weight (kg)
timeFrame: 6 months, 12 months, 18 months
Secondary outcomes:
measure: Percentage of body weight lost
timeFrame: 6 months, 12 months, 18 months
measure: Change in blood pressure (mm Hg)
timeFrame: 6 months, 12 months, 18 months
measure: Change in health-related quality of life as determined by the RAND-36 PCS or MCS
timeFrame: 6 months, 12 months, 18 months
measure: Change in physical activity (steps per day)
timeFrame: 6 months, 12 months, 18 months
measure: Change in dietary pattern
timeFrame: 6 months, 12 months, 18 months
measure: Satisfaction with program
timeFrame: 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kathleen McTigue, MD MS MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.