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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05123989
Other study ID # WELLTORY-CT001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Welltory Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of personalized move goals in the Welltory mobile app on daily step count among adults from 30 to 65 years old. The study also aims to assess how personalized move goals impact workout quality and frequency.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Personalized move goals
Personalized move goals delivered by the Welltory mobile app
Constant move goals
Static move goal delivered by the Welltory mobile app

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Welltory Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Average Steps per Day at 4 weeks Baseline, 4 weeks
Primary Change from Baseline Average Steps per Day at 8 weeks Baseline, 8 weeks
Primary Change from Baseline Average Steps per Day at 12 weeks Baseline, 12 weeks
Primary Change from Baseline Average Steps per Day at 24 weeks Baseline, 24 weeks
Secondary Change from Baseline Body Weight at 12 weeks Body weight in kilograms Baseline, 12 weeks
Secondary Change from Baseline Body Weight at 24 weeks Body weight in kilograms Baseline, 24 weeks
Secondary Workouts at 4 weeks Total number of workouts over 20 minutes during first 4 weeks of intervention 4 weeks
Secondary Workouts at 8 weeks Total number of workouts over 20 minutes during first 8 weeks of intervention 8 weeks
Secondary Workouts at 12 weeks Total number of workouts over 20 minutes during first 12 weeks of intervention 12 weeks
Secondary Workouts at 24 weeks Total number of workouts over 20 minutes during 24 weeks of intervention 24 weeks
Secondary Active calories during workouts at 4 weeks All active calories burned during workouts over 20 minutes 4 weeks
Secondary Active calories during workouts at 8 weeks All active calories burned during workouts over 20 minutes 8 weeks
Secondary Active calories during workouts at 12 weeks All active calories burned during workouts over 20 minutes 12 weeks
Secondary Active calories during workouts at 24 weeks All active calories burned during workouts over 20 minutes 24 weeks
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