Back to results

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

Primary Purpose

Obesity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

More-Intensive

Less-Intensive

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Internet

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

More-Intensive

Less-Intensive

Arm Description

Outcomes

Primary Outcome Measures

Change in body weight (kg)

Secondary Outcome Measures

Percentage of body weight lost

Change in blood pressure (mm Hg)

Change in health-related quality of life as determined by the RAND-36 PCS or MCS

Change in physical activity (steps per day)

Change in dietary pattern

Satisfaction with program

Full Information

NCT ID

NCT01043718

First Posted

January 5, 2010

Last Updated

January 13, 2016

Sponsor

University of Pittsburgh

Collaborators

Milton S. Hershey Medical Center, United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT01043718

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

Milton S. Hershey Medical Center, United States Department of Defense

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Internet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

More-Intensive

Arm Type

Experimental

Arm Title

Less-Intensive

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

More-Intensive

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Less-Intensive

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in body weight (kg)

Time Frame