- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05123989
Evaluating the Impact of Personalized Move Goals on Physical Activity
Evaluating the Impact of Personalized Move Goals in a Mobile App on Physical Activity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Welltory app sends users messages with move goals to help people move smarter. Adapted daily based on each user's historical data and overall wellbeing, Welltory's move goals gradually increase physical activity levels, motivating sedentary people to move more without demanding drastic lifestyle changes.
This randomized controlled study will assess if messages with personalized move goals in the Welltory mobile app help increase physical activity among adults.
Participants include individuals aged 30-65 who use iPhones, wear an Apple Watch, and lead sedentary lifestyles (their median daily step count does not exceed 6,000). Participants are selected among active Wellotry mobile app users who had previously not received any messages with move goals.
All participants are randomly assigned to 3 groups:
- Participants in group 1 receive daily messages with personalized move goals in the Welltory mobile app. Personalized move goals are computed based on each participant's historical physical activity data and their daily wellbeing.
- Participants in group 2 receive daily messages with a static move goal of 10,000 steps per day in the Welltory mobile app.
- Participants in group 3 use the Welltory mobile app but don't receive any messages with move goals.
For all participants, steps and workouts are automatically registered by their Apple Watch wearable devices and the Welltory mobile app. Additionally, participants regularly measure their body weight and manually record it in the Welltory mobile app.
This study's duration spans a total of 24 weeks for each participant.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Using an iPhone smartphone
- Using an Apple Watch
- Willing to use the Welltory app every day for 6 months
- Median daily step count is less than 6,000 in the month before the beginning of this study
Exclusion Criteria:
- Already participating in another physical activity study
- Known medical conditions or physical problems that require special attention in an exercise program
- Pregnant/gave birth in the past 6 month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Personalized move goals
Participants will be sent daily messages in the Welltory mobile app with personalized move goals that are based on each participant's historical physical activity data and their daily wellbeing
|
Personalized move goals delivered by the Welltory mobile app
|
Active Comparator: Constant move goals
Participants will be sent daily messages in the Welltory mobile app with a static move goal of 10,000 steps per day
|
Static move goal delivered by the Welltory mobile app
|
No Intervention: No intervention
Participants will not be sent any messages with move goals in the Welltory mobile app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline Average Steps per Day at 4 weeks
Time Frame: Baseline, 4 weeks
|
Baseline, 4 weeks
|
Change from Baseline Average Steps per Day at 8 weeks
Time Frame: Baseline, 8 weeks
|
Baseline, 8 weeks
|
Change from Baseline Average Steps per Day at 12 weeks
Time Frame: Baseline, 12 weeks
|
Baseline, 12 weeks
|
Change from Baseline Average Steps per Day at 24 weeks
Time Frame: Baseline, 24 weeks
|
Baseline, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Body Weight at 12 weeks
Time Frame: Baseline, 12 weeks
|
Body weight in kilograms
|
Baseline, 12 weeks
|
Change from Baseline Body Weight at 24 weeks
Time Frame: Baseline, 24 weeks
|
Body weight in kilograms
|
Baseline, 24 weeks
|
Workouts at 4 weeks
Time Frame: 4 weeks
|
Total number of workouts over 20 minutes during first 4 weeks of intervention
|
4 weeks
|
Workouts at 8 weeks
Time Frame: 8 weeks
|
Total number of workouts over 20 minutes during first 8 weeks of intervention
|
8 weeks
|
Workouts at 12 weeks
Time Frame: 12 weeks
|
Total number of workouts over 20 minutes during first 12 weeks of intervention
|
12 weeks
|
Workouts at 24 weeks
Time Frame: 24 weeks
|
Total number of workouts over 20 minutes during 24 weeks of intervention
|
24 weeks
|
Active calories during workouts at 4 weeks
Time Frame: 4 weeks
|
All active calories burned during workouts over 20 minutes
|
4 weeks
|
Active calories during workouts at 8 weeks
Time Frame: 8 weeks
|
All active calories burned during workouts over 20 minutes
|
8 weeks
|
Active calories during workouts at 12 weeks
Time Frame: 12 weeks
|
All active calories burned during workouts over 20 minutes
|
12 weeks
|
Active calories during workouts at 24 weeks
Time Frame: 24 weeks
|
All active calories burned during workouts over 20 minutes
|
24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WELLTORY-CT001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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