Overweight and ObesityNCT03136692
Analysis of De-identified Data From Commercially-available App Lose It!
An observational study of Overweight and Obesity, run by Johns Hopkins Bloomberg School of Public Health.
Trial summary
The study team analyzed de-identified user data provided by the commercial app Lose It!, an entity of FitNow, Inc. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Lose It! commercial weight loss app
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7,007 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: New app users located in the U.S. and Canada, between 18 and 80 years of age, that are overweight (25 < BMI < 30) or obese (BMI > 30), who actively used the app each month from January to May of 2016, defined as users who logged food at least 8 times during the first or second half of each month (January, February, March, April and May).
Who may be able to join
- New app users located in the U.S. and Canada, between 18 and 80 years of age, that are overweight (25 < BMI < 30) or obese (BMI > 30), who actively used the app each month from January to May of 2016, defined as users who logged food at least 8 times during the first or second half of each month (January, February, March, April and May).
Who cannot join
- -
About this study
The study team analyzed de-identified user data provided by the commercial app Lose It!, an entity of FitNow, Inc.
Read the detailed description
The study team analyzed de-identified user data collected by Lose It! for the purposes of investigating behavioral aspects of weight loss and maintenance, including engagement with the platform; user-reported data on diet, exercise, and other behaviors; data generated by Lose It! describing macronutrient or total calorie intake; periodicity of weight-related actions; user-reported demographic information; and any data from linked applications within Lose It!. All data was anonymized and exchanged as limited data sets.
- Conditions
- Overweight and Obesity
- Being tested
- Lose It! commercial weight loss app
- Keywords
- app, weight loss, diet, behavior
- Medical subject headings
- Overweight, Obesity, Alzheimer Disease, Weight Loss, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lose It! commercial weight loss appBehavioural
Lose It! is a commercial weight loss smart phone app designed for easy caloric tracking. It provides a free mobile and web interface for users to construct an individualized weight loss plan by entering their goal weight and desired weekly weight loss. Using the user's height, current weight, gender and age, the app generates a daily caloric budget designed for the user to reach their goal. Users can then log their caloric intake, exercise, and weight to track progress toward their goal.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent body weight lost
Percent body weight lost over first five months of 2016
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 May 2016
- Primary completion1 May 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- FitNow Inc
- Responsible party
- Sponsor
- Investigators
- Lawrence Cheskin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136692
- Sponsor's protocol ID
- Lose It! data analysis
- Status last verified
- Sep 2022
- First submitted
- 28 Apr 2017
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill C, Weir BW, Fuentes LW, Garcia-Alvarez A, Anouti DP, Cheskin LJ. Relationship Between Weekly Patterns of Caloric Intake and Reported Weight Loss Outcomes: Retrospective Cohort Study. JMIR Mhealth Uhealth. 2018 Apr 16;6(4):e83. doi: 10.2196/mhealth.8320.
PubMed 29661750
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of De-identified Data From Commercially-available App Lose It!
- ClinicalTrials.gov ID
- NCT03136692
- Acronym / sponsor ID
- Lose It! data analysis
- Conditions
- Overweight and Obesity
- Keywords
- app, weight loss, diet, behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,007 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- FitNow Inc
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study team analyzed de-identified user data provided by the commercial app Lose It!, an entity of FitNow, Inc.
Detailed description
The study team analyzed de-identified user data collected by Lose It! for the purposes of investigating behavioral aspects of weight loss and maintenance, including engagement with the platform; user-reported data on diet, exercise, and other behaviors; data generated by Lose It! describing macronutrient or total calorie intake; periodicity of weight-related actions; user-reported demographic information; and any data from linked applications within Lose It!. All data was anonymized and exchanged as limited data sets.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- New app users located in the U.S. and Canada, between 18 and 80 years of age, that are overweight (25 < BMI < 30) or obese (BMI > 30), who actively used the app each month from January to May of 2016, defined as users who logged food at least 8 times during the first or second half of each month (January, February, March, April and May).
Key inclusion criteria (1 listed)
- New app users located in the U.S. and Canada, between 18 and 80 years of age, that are overweight (25 < BMI < 30) or obese (BMI > 30), who actively used the app each month from January to May of 2016, defined as users who logged food at least 8 times during the first or second half of each month (January, February, March, April and May).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lose It! commercial weight loss appLose It! is a commercial weight loss smart phone app designed for easy caloric tracking. It provides a free mobile and web interface for users to construct an individualized weight loss plan by entering their goal weight and desired weekly weight loss. Using the user's height, current weight, gender and age, the app generates a daily caloric budget designed for the user to reach their goal. Users can then log their caloric intake, exercise, and weight to track progress toward their goal. | Behavioural | – |
Primary outcome
Percent body weight lost
Time frame: five months
Percent body weight lost over first five months of 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Results publication: PubMed 29661750Hill C, Weir BW, Fuentes LW, Garcia-Alvarez A, Anouti DP, Cheskin LJ. Relationship Between Weekly Patterns of Caloric Intake and Reported Weight Loss Outcomes: Retrospective Cohort Study. JMIR Mhealth Uhealth. 2018 Apr 16;6(4):e83. doi: 10.2196/mhealth.8320.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Cheskin, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent body weight lost (time frame: five months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.