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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01043757
Other study ID # HBS-MN01
Secondary ID
Status Withdrawn
Phase N/A
First received January 6, 2010
Last updated June 23, 2015
Start date January 2010
Est. completion date October 2013

Study information

Verified date January 2010
Source Harvard University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Participants will be employees of Genzyme who volunteer to participate in a study on motivating healthy behaviors, involving giving them goals for taking a certain number of steps per day, and increasing that number over time. Participants will wear pedometers and upload their data to a website that allows them to monitor their progress, and have the opportunity to win money based on meeting their step goals.

Interested employees will schedule a day and time to complete a health screening at a "Health Fair" at their place of employment, to ensure that they are healthy enough to participate; at this time participants will also complete the investigators baseline dependent measures, and receive a pedometer. After a one-week baseline period during which they wear the pedometer and the investigators establish their typical number of steps per day, eligible participants will then be assigned to one of four treatments - a "no incentive" control condition, and three conditions in which they are entered into different kinds of monetary lotteries if they have met their step goals for that day. Participants' initial goal will be based on their steps during the baseline period, and the goal will increase by 250 steps each week, for a total of 12 weeks. After these 3 months, the incentives portion of the experiment ends, but participants continue to wear their pedometers and upload their data for an additional 6 months. At 3 months, 6 months, and then at the study end at 9 months, participants again complete the investigators dependent measures at follow-up Health Fairs at their place of employment.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- BMI of 28 or higher

- Pass the Par-Q

- answer "No" to all Par-Q questions

- at least 18 years of age

- has computer at home or work with compatible operating system (i.e. windows 2000, windows xp, windows vista, osX 10.3-10.5), internet access, and usb port

Exclusion Criteria:

- Anyone who does not meet all of the inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial incentives for increasing physical exercise
Throughout the 12-week intervention, participants will receive step goals. The step goals will increase by 250 steps per week, The intervention will last a total of 12 weeks. After each seven-day week, step goals will increase by an additional 250 steps - thus over the 12 weeks, participants will be asked to increase their daily step count by 3,000. Participants will receive financial incentives to attain these step goals; the incentive schemes differ according to intervention arm.

Locations

Country Name City State
United States Genzyme Cambridge Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Harvard University Blue Cross Blue Shield, Genzyme, a Sanofi Company, Partners HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity 12 weeks No
Secondary RAND 36-item Health Survey 3mo, 6mo, 9mo No
Secondary Health Stress questionnaire 3mo, 6mo, 9mo No
Secondary Emotional, Work, and Financial Attitudes questionnaire 3mo, 6mo, 9mo No
Secondary Weight loss 3mo, 6mo, 9mo No
Secondary Hemoglobin A1C 6mo No
Secondary Health behaviors questionnaire 3mo, 6mo, 9mo No
Secondary Word of mouth 6mo, 9mo No
Secondary Physical activity 6mo, 9mo No
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