Evaluating the Impact of Personalized Move Goals on Physical Activity

May 1, 2023 updated by: Welltory Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: Personalized move goals
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
Behavioral: Constant move goals
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Welltory Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WELLTORY-CT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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