Evaluating the Impact of Personalized Move Goals on Physical Activity

Physical Activity Clinical Trial

Official title:

Evaluating the Impact of Personalized Move Goals in a Mobile App on Physical Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05123989
• Other study ID #: WELLTORY-CT001
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Physical Activity
• Sedentary Lifestyle

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