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Completed

NCT Number: NCT01043718

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

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).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in body weight (kg)

    Time frame: 6 months, 12 months, 18 months

Secondary outcomes

  1. Percentage of body weight lost

    Time frame: 6 months, 12 months, 18 months

  2. Change in blood pressure (mm Hg)

    Time frame: 6 months, 12 months, 18 months

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

    Time frame: 6 months, 12 months, 18 months

  4. Change in physical activity (steps per day)

    Time frame: 6 months, 12 months, 18 months

  5. Change in dietary pattern

    Time frame: 6 months, 12 months, 18 months

  6. Satisfaction with program

    Time frame: 6 months, 12 months, 18 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 7, 2010
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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