NCT01043757

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

June 24, 2015

Status Verified

January 1, 2010

Enrollment Period

3.2 years

First QC Date

January 6, 2010

Last Update Submit

June 23, 2015

Conditions

Keywords

Sedentary lifestylephysical exercisebehavioral economicsfinancial incentivesobesity

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    12 weeks

Secondary Outcomes (8)

  • RAND 36-item Health Survey

    3mo, 6mo, 9mo

  • Health Stress questionnaire

    3mo, 6mo, 9mo

  • Emotional, Work, and Financial Attitudes questionnaire

    3mo, 6mo, 9mo

  • Weight loss

    3mo, 6mo, 9mo

  • Hemoglobin A1C

    6mo

  • +3 more secondary outcomes

Study Arms (4)

Control

EXPERIMENTAL

1\) Control Group. Receives daily step goals via emails and has access to the study website to allow them to track their progress. Eligible for check-in incentives.

Behavioral: Financial incentives for increasing physical exercise

Fixed

EXPERIMENTAL

Receives control intervention plus are incentivized to attain their daily step goals through daily lotteries: Each day, we will draw a two-digit number. If the first digit OR the second digit of this daily number matches the participant's lucky number, they win the small jackpot. If both digits match, they receive the large jackpot. Participants who meet their step goal for the day and who upload their data will be entered into the same lottery each day, where the small jackpot is $10 and the large jackpot is $100.

Behavioral: Financial incentives for increasing physical exercise

Ascending

EXPERIMENTAL

Receives control intervention plus incentivized to attain daily step goals through lotteries: Each day, we will draw a two-digit number. If the first digit OR the second digit of this daily number matches the participant's lucky number, they win the small jackpot. If both digits match, they receive the large jackpot. Participants can increase their daily jackpots by meeting their step goals. Those who meet their goal for the first day of the week and who upload their data will be entered into a lottery where the small jackpot is $4 and the large jackpot is $40; if they successfully meet their step goal on the first day of the week, the jackpots for the second day increase to $6/$60, and so on such that if they reach their goals each day, the jackpots on day seven will reach $16/$160.

Behavioral: Financial incentives for increasing physical exercise

Decreasing

EXPERIMENTAL

Receives control intervention plus incentivized to attain daily step goals through lotteries: Daily drawing procedure same as Ascending condition; structure of incentives is different: Participants can decrease their daily jackpots by failing to meet their step goals. Those who meet their goal for the first day of the week and who upload their data will be entered into a lottery where the small jackpot is $16 and the large jackpot is $160; if they successfully meet their step goal on the first day of the week, the jackpots will remain at $16/$160; if they do not meet their goal the jackpots will decrease to $14/$140, and so on such that if they fail to reach their goals each day, the jackpots on day seven will decrease to $4/$40.

Behavioral: Financial incentives for increasing physical exercise

Interventions

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.

AscendingControlDecreasingFixed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genzyme

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorObesityMotor Activity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael I. Norton, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2013

Study Completion

October 1, 2013

Last Updated

June 24, 2015

Record last verified: 2010-01

Locations