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

NCT01043718 | Completed Phase 2 DMC

• 1 other identifier: HMC32877
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

Obesity; Internet

Outcome Measures

Primary Outcomes (1)

• Change in body weight (kg)

  6 months, 12 months, 18 months

Secondary Outcomes (6)

• 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

Study Arms (2)

More-Intensive

EXPERIMENTAL

Behavioral: More-Intensive

Less-Intensive

ACTIVE COMPARATOR

Behavioral: Less-Intensive

Interventions

More-Intensive BEHAVIORAL

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.

More-Intensive

Less-Intensive BEHAVIORAL

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.

Less-Intensive

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Milton S. Hershey Medical Center: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.

  PMID: 12453955 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen McTigue, MD MS MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)