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

Purpose

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).

Condition	Intervention	Phase
Obesity	Behavioral: More-Intensive Behavioral: Less-Intensive	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Change in body weight (kg) [ Time Frame: 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of body weight lost [ Time Frame: 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
Change in blood pressure (mm Hg) [ Time Frame: 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
Change in health-related quality of life as determined by the RAND-36 PCS or MCS [ Time Frame: 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
Change in physical activity (steps per day) [ Time Frame: 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
Change in dietary pattern [ Time Frame: 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
Satisfaction with program [ Time Frame: 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	March 2010
Estimated Study Completion Date:	December 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: More-Intensive	Behavioral: More-Intensive The online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program. The program will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. The program curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives.
Active Comparator: Less-Intensive	Behavioral: Less-Intensive The participants will be provided with the information to access the online Diabetes Prevention Program (DPP) intervention materials. Following the original DPP trial, all DPP materials were placed online for the public to access. This group will receive a lifestyle counseling session and tools to facilitate their intervention.

Arms

Assigned Interventions

Experimental: More-Intensive

Behavioral: More-Intensive

The online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program. The program will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. The program curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives.

Active Comparator: Less-Intensive

Behavioral: Less-Intensive

The participants will be provided with the information to access the online Diabetes Prevention Program (DPP) intervention materials. Following the original DPP trial, all DPP materials were placed online for the public to access. This group will receive a lifestyle counseling session and tools to facilitate their intervention.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043718

Locations

United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

University of Pittsburgh

Milton S. Hershey Medical Center

Department of Defense

Investigators

Principal Investigator:

Kathleen McTigue, MD MS MPH

University of Pittsburgh

More Information

Publications:

Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71.

Responsible Party:	Kathleen McTigue, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01043718 History of Changes
Other Study ID Numbers:	HMC32877
Study First Received:	January 5, 2010
Last Updated:	April 26, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Obesity
Internet

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013