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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Behavioral: More-Intensive; Behavioral: Less-Intensive

• Registration Number: NCT01043718
• Lead Sponsor: University of Pittsburgh

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-07
• Study Start: 2010-03
• Primary Completion: 2012-01
• Study Completion: 2012-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
More-Intensive	More-Intensive	-
Less-Intensive	Less-Intensive	-

Primary Outcome Measures

Name	Time	Method
Change in body weight (kg)	6 months, 12 months, 18 months

Secondary Outcome Measures

Name	Time	Method
Percentage of body weight lost	6 months, 12 months, 18 months
Change in blood pressure (mm Hg)	6 months, 12 months, 18 months
Change in health-related quality of life as determined by the RAND-36 PCS or MCS	6 months, 12 months, 18 months
Change in physical activity (steps per day)	6 months, 12 months, 18 months
Change in dietary pattern	6 months, 12 months, 18 months
Satisfaction with program	6 months, 12 months, 18 months

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States