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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02907164
Other study ID # 201608038
Secondary ID
Status Enrolling by invitation
Phase N/A
First received September 3, 2016
Last updated September 15, 2016
Start date September 2016
Est. completion date January 2017

Study information

Verified date September 2016
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators are interested in using social norms to motivate people to sign up for a 100-day exercise challenge and exploring how to make social norms messages more effective.


Description:

The investigators are interested in using social norms to motivate people to sign up for a 100-day exercise challenge and exploring how to make social norms messages more effective. Specifically, the primary purposes of this study are to test (a) whether social norms messages (i.e., information about how many people have signed up for the challenge) can increase signup rates and eventually lead people to exercise more and (b) whether such messages become more effective when they highlight different types of motivations (intrinsic vs. extrinsic motivations). Through a partnership with a university, the investigators are running a large-scale, randomized field controlled trial aimed at increasing sign-ups for the challenge and exercise frequencies during the challenge.

Benefits-eligible employees at the partner university are randomly assigned to one of four experimental conditions and receive the corresponding version of email message encouraging them to sign up for the challenge.

(1) In the control group, the email does not mention the number of people who have signed up. (2) In the norm condition, the email mentions the number of people who have signed up. (3) In the norm and health motive condition, the email mentions the number of people who have signed up, and highlights that the challenge is designed to help people to stay fit in a fun way. (4) In the norm and reward motive condition, the email mentions the number of people who have signed up, and highlights that the challenge is designed to help people to stay active and earn rewards.

The investigators hypothesize that Groups 2, 3, and 4 will have a higher sign-up rate and higher exercise frequencies on average than Group 1, because positive social norms should motivate people to engage in the target, desirable behavior. Also, the investigators will compare sign-up rates and exercise frequencies between Groups 2, 3, and 4 to examine whether highlighting intrinsic and extrinsic motives can further increase sign-up rates and overall exercise frequencies than only giving social norms information.

All benefits-eligible employees at the partner university for whom the Human Resource (HR) office has an email address on record receive invitation emails from HR. The invitation emails that contain the interventions are sent out one week AFTER the registration period has started, because HR needs to know how many people sign up in the first week and use this information to create a social norms message. Employees who sign up for the challenge during the first week of the registration period (i.e., prior to the implementation of the interventions) cannot be affected by the interventions. Thus, the investigators decide in advance that these employees will be excluded from analysis.

Employees will receive two emails that are sent eight days apart from each other. Thus, the investigators plan to examine both the sign-up rates within one week after each email goes out and the overall sign-up rates throughout the 50-day registration period.

The investigators plan to explore moderators based on (a) employees' demographics (age, gender, ethnicity, position), (b) employees' participation in previous challenges, and (c) employees' health condition and fitness level prior to the challenge (such as how actively they have been participating in other wellness activities, their health statistics).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 15000
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All benefits-eligible employees at partner university for whom the Human Resource office has an email address on record

Exclusion Criteria:

- Employees who sign up for the challenge prior to the implementation of the interventions will NOT be included in the analysis.

(The interventions are implemented one week after the registration period has started. The partner university has to send invitation emails to all benefits-eligible employees with an email address on record, including those who already signed up. However, employees who already signed up cannot be affected by the interventions and thus will be excluded from the analysis.)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Email invitation
Receive emails encouraging them to sign up
Social norm
Receive information about how many people have signed up
Intrinsic, health motive
Receive information about how the challenge helps people to stay fit in a fun way
Extrinsic, reward motive
Receive information about how the challenge helps people to stay active and earn rewards

Locations

Country Name City State
United States Hengchen Dai St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of people who sign up for the challenge Whether or not each person signs up for the challenge during the registration period During the registration period, 50 days No
Primary Activity level Number of steps taken each day, as recorded in participants' online portal Through study completion, 100 days No
Secondary Body Mass Index (BMI) most recent BMI in pounds (weight) and inches (height) as entered by participant, an expected average of 2 months after study start. Obtaining the data is dependent on the ability to obtain the data from the online portal. Most recent BMI as entered by participant, an expected average of 2 months after study start No
Secondary cholesterol Most recent total, low, and high cholesterol levels in mg/dl as entered by participant, an expected average of 2 months after study start. Obtaining the data is dependent on the ability to obtain the data from the online portal. Most recent cholesterol as entered by participant, an expected average of 2 months after study start No
Secondary blood pressure Most recent systolic and diastolic levels in mmHg as entered by participant, an expected average of 2 months after study start. Obtaining the data is dependent on the ability to obtain the data from the online portal. Most recent blood pressure as entered by participant, an expected average of 2 months after study start No
Secondary stress Most recent self-reported stress level on a 1-5 scale (with 1 indicating "Relaxed" and 5 indicating "Highly Stressed") as entered by participant, an expected average of 2 months after study start. Obtaining the data is dependent on the ability to obtain the data from the online portal. Most recent stress as entered by participant, an expected average of 2 months after study start No
Secondary Email open and click rates The rates at which people in each experimental condition read the invitation emails and click on links in the emails Through study completion, 100 days No
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