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OpenTrials
Completed

NCT Number: NCT00792207

The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults

Hypothesis: Overweight subjects using a Virtual Coach will demonstrate improved adherence to an exercise regime.

This study is designed to examine the effect of a computer program called a "Virtual Coach" and find out if it helps people become more active. This program acts as a kind of a personal trainer and will give you feedback. All participants in the study will receive an activity monitor to wear during the study and a website to use to track activity. Half of the participants will also receive the virtual coach software. This software will have to be downloaded onto your computer, and we will ask that you check in with the coach using the software three times a week for 12 weeks. The group you will be placed in will be selected by chance.

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Key information

Conditions

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

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Partners Health Care Center for Connected Health

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults age 20-55 inclusive
  • BMI between 25 and 35 inclusive (overweight and Class 1 obese subjects)
  • PC Computer with an available USB port, speakers and high-speed internet access in a secure setting (home or private office)
  • Fluency in English (spoken and written)
  • Have a Primary Care Physician
  • Answer "No" to all 7 questions on PAR-Q OR have letter from PCP clearing them to take part in study

Exclusion criteria

  • Disability, medical or surgical condition preventing or precluding moderate physical activity.
  • Cognitive impairment.

Treatment and study plan

Virtual Coach software

Other

The intervention being tested, the Virtual Coach, is an automated empathic computer agent which will run on patient's home computer and engage the patient in dialogues to deliver personalized feedback, education and coaching based on physiological data.

Activity monitor and website

Other

The control group will use an activity monitor and a website to track activity levels.

Primary outcomes

  1. The primary outcome being measured is the level of activity monitored by the activity monitor. Control and Intervention subjects will be encouraged to wear the activity monitor on a daily basis for the 12 week course of the study.

    Time frame: 12 weeks

Secondary outcomes

  1. Change in subject weight. Subjects will be weighed at their first study visit and their final visit.

    Time frame: 12 weeks

  2. Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit

    Time frame: 12 weeks

  3. Subject rating on the working alliance inventory score

    Time frame: 12 weeks, assessed at the end of the study

  4. Changes in self-efficacy, quality of or readiness to change (as measured through surveys at the beginning and end of the study).

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • FitSense/FitLinxx
  • Northeastern University

Registry information

Acronym: StepUp

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 17, 2008
Registry last updated
Dec 4, 2009

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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