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

January 13, 2016 updated by: Kathleen McTigue, University of Pittsburgh

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight (kg)
Time Frame: 6 months, 12 months, 18 months
6 months, 12 months, 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

United States Department of Defense
Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Kathleen McTigue, MD MS MPH, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMC32877

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on More-Intensive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe