Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study

University of Pittsburgh

Status and phase

Completed

Phase 3

Phase 2

Conditions

Obesity

Treatments

Behavioral: More-Intensive

Behavioral: Less-Intensive

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01043718

HMC32877

Details and patient eligibility

About

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).

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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