Weight LossNCT02812264
Using an API to Commercialize an Evidence-Based Weight Loss Intervention
A study testing API App, Non-API App and fitness tracker in people with Weight Loss and Health Behavior, run by Coeus Health, LLC at 1 site in United States.
Trial summary
This study will test the effectiveness of a mobile application that uses an Application Program Interface (API) to distribute evidence-based weight loss interventions. Half of the participants will receive this API-based application, and the other half of the participants will use a non API-based application. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Health Behavior
- What is being tested?
- API App, Non-API App and fitness tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2017to 1 Dec 2019
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- informed consent
- between 21-65 years old
- BMI between 25-40 kg/m2
- ownership and use of an Android smartphone during past 6 months with no plans to change phone/service during study
- consent for research team to monitor app utilization
Who cannot join
- use of weight loss medication
- prior or planned bariatric surgery
- psychiatric hospitalization in past 12 months
- pregnancy, nursing, or planned pregnancy during the study
- history of cardiovascular disease (CVD) event
- self-reported history of an eating disorder
Show all 11Show fewer
- use of medication for diabetes mellitus
- mobility restrictions for which exercise is contraindicated
- history of a condition (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated
- current participation in another weight treatment study and/or recent weight loss >10%
- investigator discretion for safety reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
Coeus Health Offices
State College, Pennsylvania, 16801
About this study
This study will test the effectiveness of a mobile application that uses an Application Program Interface (API) to distribute evidence-based weight loss interventions. Half of the participants will receive this API-based application, and the other half of the participants will use a non API-based application.
Read the detailed description
The purpose of this study is to test a weight loss app that uses an API to disseminate an evidence-based weight loss intervention. The investigators hypothesize that, over the course of 12 months, participants using the Leaner app will have lost more weight than those in the attention control group.
Participants (n=206) will be randomly assigned to use either the intervention app (intervention arm; n=103) or a weight loss app of their choosing (attention control arm; n=103) for 12 months. Assessments will take place at baseline, and 3, 6, and 12 months.
Statistical analysis: A linear mixed modeling approach will be used to test the hypothesis. Observed weight vs. time plots will be analyzed for all participants to discern general trends in weight change. The model will include an intervention effect, a time effect, an intervention by time interaction, and a random intercept.
In exploratory analysis, investigators will examine weight change across subgroups of interest; investigators will add the subgroup variable and its interaction with the intervention indicator to the primary model. All analyses will be evaluated at the 0.05 significance level.
- Conditions
- Weight Loss, Health Behavior
- Being tested
- API App, Non-API App, fitness tracker, scale
- Medical subject headings
- Weight Loss, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
API AppBehavioural
Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale
Non-API AppBehavioural
Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.
fitness trackerBehavioural
Also called wearable
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
scaleBehavioural
Also called weight
Connected scale that will transfer weight information to app
| Study group | Role | What they receive |
|---|---|---|
| API App | Experimental | use of API weight loss mobile application for 12 months, plus fitness tracker and scale. Receives: Behavioral: API App; Behavioral: fitness tracker; Behavioral: scale |
| Attention Control | Active comparator | use of non-API app for weight loss over 12 months, plus fitness tracker and scale. Receives: Behavioral: Non-API App; Behavioral: fitness tracker; Behavioral: scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Change in body weight over course of study
Measured: up to 12 months
Secondary outcomes (16)
Weight Change - 3 months
Initial weight change
Measured: up to 3 months
Weight Change - 6 months
mid-point weight change
Measured: up to 6 months
Automated Self-Administered 24-hour Dietary recall (ASA-24)
Dietary patterns/24-hour dietary recall
Measured: baseline, 3-, 6-, 12-months
Physical Activity
Paffenbarger survey to capture physical activity patterns. Assesses self-report leisure time physical activity and weekly kilocalorie expenditure.
Measured: baseline, 3-, 6-, 12-months
Blood Pressure
Using a blood pressure cuff, measured three times at 1-minute intervals after 5 minutes of quiet sitting. Average of final two measurements is used.
Measured: baseline, 3-, 6-, 12-months
Fasting Lipid Profile
finger stick blood samples will be collected, following an overnight fast, to analyze fasting lipid profile. Samples will be analyzed using the Cholestech LDX
Measured: baseline, 3-, 6-, 12-months
Plasma Glucose
finger stick blood samples will be collected, following an overnight fast, to analyze plasma glucose. Samples will be analyzed using the Cholestech LDX
Measured: baseline, 3-, 6-, 12-months
High Sensitivity C-Reactive Protein
finger stick blood samples will be collected, following an overnight fast, to analyze high sensitivity c-reactive protein. Samples will be analyzed using the Cholestech LDX
Measured: baseline, 3-, 6-, 12-months
Patient Health Questionnaire (PHQ) 9
Nine-item self-report assessment of depression severity.
Measured: baseline, 3-, 6-, 12-months
Body Shape Questionnaire (BSQ)
8-item self-report questionnaire about concern with body shape.
Measured: baseline, 3-, 6-, 12-months
Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)
24-item self-report measure of disordered eating cognitions.
Measured: baseline, 3-, 6-, 12-months
Questionnaire of Eating and Weight Patterns
Eight-item self-report measure of binge eating behaviors.
Measured: baseline, 3-, 6-, 12-months
Medical Outcomes Survey: Social Support
19-item self-report assessment of social support.
Measured: baseline, 3-, 6-, 12-months
EuroQOL Health Related Quality of Life Scale
16-item self-report assessment of health related quality of life.
Measured: baseline, 3-, 6-, 12-months
The Health and Work Performance Questionnaire (HPQ)
Presenteeism/Absenteeism items from the self-report HPQ.
Measured: baseline, 3-, 6-, 12-months
App engagement
Using technology on smart phones, we will monitor participants' app usage throughout the course of the study.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study start7 Jun 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coeus Health, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812264
- Sponsor's protocol ID
- 4R44DK103519-02
- Status last verified
- Jul 2020
- First submitted
- 10 Jun 2016
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an API to Commercialize an Evidence-Based Weight Loss Intervention
- ClinicalTrials.gov ID
- NCT02812264
- Acronym / sponsor ID
- 4R44DK103519-02
- Conditions
- Weight Loss, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Coeus Health, LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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.
This study will test the effectiveness of a mobile application that uses an Application Program Interface (API) to distribute evidence-based weight loss interventions. Half of the participants will receive this API-based application, and the other half of the participants will use a non API-based application.
Detailed description
The purpose of this study is to test a weight loss app that uses an API to disseminate an evidence-based weight loss intervention. The investigators hypothesize that, over the course of 12 months, participants using the Leaner app will have lost more weight than those in the attention control group.
Participants (n=206) will be randomly assigned to use either the intervention app (intervention arm; n=103) or a weight loss app of their choosing (attention control arm; n=103) for 12 months. Assessments will take place at baseline, and 3, 6, and 12 months.
Statistical analysis: A linear mixed modeling approach will be used to test the hypothesis. Observed weight vs. time plots will be analyzed for all participants to discern general trends in weight change. The model will include an intervention effect, a time effect, an intervention by time interaction, and a random intercept.
In exploratory analysis, investigators will examine weight change across subgroups of interest; investigators will add the subgroup variable and its interaction with the intervention indicator to the primary model. All analyses will be evaluated at the 0.05 significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| API App | Experimental | Behavioral: API App, Behavioral: fitness tracker, Behavioral: scaleuse of API weight loss mobile application for 12 months, plus fitness tracker and scale. |
| Attention Control | Active comparator | Behavioral: Non-API App, Behavioral: fitness tracker, Behavioral: scaleuse of non-API app for weight loss over 12 months, plus fitness tracker and scale. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- informed consent
- between 21-65 years old
- BMI between 25-40 kg/m2
- ownership and use of an Android smartphone during past 6 months with no plans to change phone/service during study
- consent for research team to monitor app utilization
Key exclusion criteria (11 listed)
- use of weight loss medication
- prior or planned bariatric surgery
- psychiatric hospitalization in past 12 months
- pregnancy, nursing, or planned pregnancy during the study
- history of cardiovascular disease (CVD) event
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 |
|---|---|---|
| API AppMobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale | Behavioural | API App |
| Non-API AppMobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale. | Behavioural | Attention Control |
| fitness trackerAlso: wearablefitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app | Behavioural | API App, Attention Control |
| scaleAlso: weightConnected scale that will transfer weight information to app | Behavioural | API App, Attention Control |
Primary outcome
Weight change
Time frame: up to 12 months
Change in body weight over course of study
16 secondary outcomes
Weight Change - 3 months
Time frame: up to 3 months
Weight Change - 6 months
Time frame: up to 6 months
Automated Self-Administered 24-hour Dietary recall (ASA-24)
Time frame: baseline, 3-, 6-, 12-months
Physical Activity
Time frame: baseline, 3-, 6-, 12-months
Blood Pressure
Time frame: baseline, 3-, 6-, 12-months
Fasting Lipid Profile
Time frame: baseline, 3-, 6-, 12-months
Plasma Glucose
Time frame: baseline, 3-, 6-, 12-months
High Sensitivity C-Reactive Protein
Time frame: baseline, 3-, 6-, 12-months
Patient Health Questionnaire (PHQ) 9
Time frame: baseline, 3-, 6-, 12-months
Body Shape Questionnaire (BSQ)
Time frame: baseline, 3-, 6-, 12-months
Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)
Time frame: baseline, 3-, 6-, 12-months
Questionnaire of Eating and Weight Patterns
Time frame: baseline, 3-, 6-, 12-months
Medical Outcomes Survey: Social Support
Time frame: baseline, 3-, 6-, 12-months
EuroQOL Health Related Quality of Life Scale
Time frame: baseline, 3-, 6-, 12-months
The Health and Work Performance Questionnaire (HPQ)
Time frame: baseline, 3-, 6-, 12-months
App engagement
Time frame: through study completion, an average of 1 year
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 14 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing API App, Non-API App and fitness tracker in people with Weight Loss and Health Behavior, run by Coeus Health, LLC at 1 site in United States.
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 5 inclusion and 11 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Weight change (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.