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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Kathleen McTigue, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01043718
First received: January 5, 2010
Last updated: April 26, 2012
Last verified: April 2012
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Kathleen McTigue, MD MS MPH University of Pittsburgh
  More Information

Publications:
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 July 26, 2014