Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06023342 |
Other study ID # |
123207 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 1, 2023 |
Est. completion date |
August 1, 2024 |
Study information
Verified date |
August 2023 |
Source |
Western University, Canada |
Contact |
Marc Mitchell, PhD |
Phone |
519-661-2111 |
Email |
marc.mitchell[@]uwo.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This will be a 24-week prospective study that will incorporate user base data of WayBetter
Inc.'s app, "WayBetter," to examine user mHealth app engagement. The primary objective of
this study is to examine predictors (i.e., socio-demographics, past health behaviours,
psychological determinants, app engagement metrics) of (a) initial six-month subscription and
b) subscription renewal rates at six months for the WayBetter app. The secondary objective is
to characterize WayBetter app engagement over the first 24 weeks of app use.
Participants will be asked to complete a survey that aims to collect the information
regarding individual-level socio-demographics, previous health behaviours, and
behavioural/personality traits. App engagement metrics will be collected from the WayBetter
app.
Description:
This will be a 24-week prospective study that will incorporate user base data of WayBetter
Inc.'s app, "WayBetter," to examine user mHealth app engagement. The primary objective of
this study is to examine predictors (i.e., socio-demographics, past health behaviours,
psychological determinants, app engagement metrics) of (a) initial six-month subscription and
b) subscription renewal rates at six months for the WayBetter app. The secondary objective is
to characterize WayBetter app engagement over the first 24 weeks of app use. Our study sample
will consist of approximately 400 adult users (aged ≥18 years old), who are new app users
(who have engaged in a 7-day free trial). As users may have varying registration dates, the
data collected will only include the first 24 weeks of an individual's interaction with the
platform.
WayBetter is a wellness lifestyle mHealth app available to anyone who wants to improve their
overall well-being. All users are asked to accept the company's privacy policy and are
prompted to fill out personal data including (but not limited to) [email address, weight]
when creating an account. All users are given a one-week free trial as well as $10 USD to use
as a deposit towards any WayBetter app game, courtesy of WayBetter Inc. Users can complete
any of the games they signed up for during their free trial, even if they decide not to
continue to their membership. To continue to participate in games, users must subscribe to a
six-month membership ($69 USD total). In general, users can join up to ten games at a time.
The app has a game directory ("explore" tab) that includes 60+ games each week in three
categories: fitness, nutrition, and mindset. New games start on Mondays, Wednesdays, and
Fridays. Each game lasts between 1-4 weeks and requires players to achieve a specific
behavioral goal (e.g., 5K Steps Per Day requires that they walk at least 5,000 steps per day
on at least 4 days per week for 2 weeks). Upon joining a game, players have an option to make
a deposit, called a "financial commitment" of $10-30, depending on the game. Multiple methods
are used to validate goal achievement. Some games require players to verify their physical
activity data by connecting their WayBetter app account (i.e., syncing) to a wearable device
or step tracking app. Other games require participants to verify their behavior by submitting
photos (e.g., photo from their wearable device or step tracking app showing that they met the
game's daily step goal; photo of meals they ate). Each game also has a social feed, where
users can view each other's posts and photo submissions and share anything related to their
fitness journey (e.g., progress, inspiration, something they are proud of). All players who
achieve the game's goal are declared "winners." Winners who made deposits are rewarded by
splitting the total pot of deposits evenly, such that they earn back their original deposit
plus addition profit, dependent on how many users 'lost'. The app incorporates an additional
gamification aspect by introducing levels; players are required to win 3 games to advance a
level (one from each category; they can choose any games they want)
WayBetter will send out a recruitment email to WayBetter users five days after they enter
into a seven-day free trial. In the email, participants will be invited to complete a study
survey via the Qualtrics link provided. After clicking on the link, participants will first
be prompted to read and respond to the study LOI. Thereafter, participants will be asked to
complete the survey which will aim to collect information about individual-level
socio-demographics (i.e., household income, rural or urban living status, gender, age, race,
and ethnicity), previous health behaviours (i.e., previous fitness, nutrition, stress, weight
loss), determinants of behavioural intentions to use health and fitness apps, and
behavioural/personality traits (i.e., risk taking traits, healthy behaviour self-efficacy,
personality traits). Participants who complete the survey will earn a $10 USD e-gift card,
distributed directly to participant provided email via the Tango Card rewards platform
(https://www.tangocard.com).
Any games that did not utilize deposit wagers (i.e., accountability partners or no
motivational booster) will not be included in the analysis. Our primary outcomes are rates of
(a) initial six-month subscription and b) subscription renewal rates at six months, for the
WayBetter app. User' specific metrics, 'psychological' metrics, and app engagement
('WayBetter' and 'Industry' specific) metrics of users who sign up for the 6-month
subscription will be used to identify underlying homogenous subgroups of individuals using
Latent Class Analysis (LCA). Next, we will examine associations between the subgroups (termed
'latent classes') to determine which users are more likely to sign-up, subscribe, and renew
subscription to the WayBetter app. We will use linear regressions and Cox Proportional Hazard
regression models to examine engagement correlates. Post Hoc analysis will be used to
determine between which users the statistical differences lie. The secondary objective is to
describe WayBetter app engagement over 24 weeks using 'WayBetter' and 'Industry' specific
engagement metrics. We will use descriptive statistics to summarize engagement patterns and
Kaplan-Meier survival curves to illustrate time to non-usage attrition and app resumption. A
repeated measures ANOVA will be used to demonstrate if statistically significant differences
exist between the user 'latent classes' and app engagement metrics. Regression equations and
a linear probability model will be formed to predict engagement metrics using latent classes
and individual-level factors (sociodemographic, previous health behaviours, determinants of
behavioural intentions to use health and fitness apps, and behavioural/personality traits) as
predictor variables. A sensitivity analysis will be completed to examine the effects of
methods of WayBetter account creation, 1) via the WayBetter online quiz (Group A) or 2)
direct download of the app on primary outcomes (Group B).