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Using an API to Commercialize an Evidence-Based Weight Loss Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812264
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Coeus Health, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Weight Loss Health Behavior Behavioral: API App Behavioral: Non-API App Behavioral: fitness tracker Behavioral: scale Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Participants will not know which arm they have been randomized to. Additionally, the investigators will be blinded to participant assignment. Randomization will be completed by the program manager.
Primary Purpose: Treatment
Official Title: Using an API to Commercialize an Evidence-Based Weight Loss Intervention
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: API App
use of API weight loss mobile application for 12 months, plus fitness tracker and scale.
Behavioral: API App
Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale

Behavioral: fitness tracker
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
Other Name: wearable

Behavioral: scale
Connected scale that will transfer weight information to app
Other Name: weight

Active Comparator: Attention Control
use of non-API app for weight loss over 12 months, plus fitness tracker and scale.
Behavioral: Non-API App
Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.

Behavioral: fitness tracker
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
Other Name: wearable

Behavioral: scale
Connected scale that will transfer weight information to app
Other Name: weight




Primary Outcome Measures :
  1. Weight change [ Time Frame: up to 12 months ]
    Change in body weight over course of study


Secondary Outcome Measures :
  1. Weight Change - 3 months [ Time Frame: up to 3 months ]
    Initial weight change

  2. Weight Change - 6 months [ Time Frame: up to 6 months ]
    mid-point weight change

  3. Automated Self-Administered 24-hour Dietary recall (ASA-24) [ Time Frame: baseline, 3-, 6-, 12-months ]
    Dietary patterns/24-hour dietary recall

  4. Physical Activity [ Time Frame: baseline, 3-, 6-, 12-months ]
    Paffenbarger survey to capture physical activity patterns. Assesses self-report leisure time physical activity and weekly kilocalorie expenditure.

  5. Blood Pressure [ Time Frame: baseline, 3-, 6-, 12-months ]
    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.

  6. Fasting Lipid Profile [ Time Frame: baseline, 3-, 6-, 12-months ]
    finger stick blood samples will be collected, following an overnight fast, to analyze fasting lipid profile. Samples will be analyzed using the Cholestech LDX

  7. Plasma Glucose [ Time Frame: baseline, 3-, 6-, 12-months ]
    finger stick blood samples will be collected, following an overnight fast, to analyze plasma glucose. Samples will be analyzed using the Cholestech LDX

  8. High Sensitivity C-Reactive Protein [ Time Frame: baseline, 3-, 6-, 12-months ]
    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

  9. Patient Health Questionnaire (PHQ) 9 [ Time Frame: baseline, 3-, 6-, 12-months ]
    Nine-item self-report assessment of depression severity.

  10. Body Shape Questionnaire (BSQ) [ Time Frame: baseline, 3-, 6-, 12-months ]
    8-item self-report questionnaire about concern with body shape.

  11. Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R) [ Time Frame: baseline, 3-, 6-, 12-months ]
    24-item self-report measure of disordered eating cognitions.

  12. Questionnaire of Eating and Weight Patterns [ Time Frame: baseline, 3-, 6-, 12-months ]
    Eight-item self-report measure of binge eating behaviors.

  13. Medical Outcomes Survey: Social Support [ Time Frame: baseline, 3-, 6-, 12-months ]
    19-item self-report assessment of social support.

  14. EuroQOL Health Related Quality of Life Scale [ Time Frame: baseline, 3-, 6-, 12-months ]
    16-item self-report assessment of health related quality of life.

  15. The Health and Work Performance Questionnaire (HPQ) [ Time Frame: baseline, 3-, 6-, 12-months ]
    Presenteeism/Absenteeism items from the self-report HPQ.

  16. App engagement [ Time Frame: through study completion, an average of 1 year ]
    Using technology on smart phones, we will monitor participants' app usage throughout the course of the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812264


Locations
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United States, Pennsylvania
Coeus Health Offices
State College, Pennsylvania, United States, 16801
Sponsors and Collaborators
Coeus Health, LLC
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Responsible Party: Coeus Health, LLC
ClinicalTrials.gov Identifier: NCT02812264    
Other Study ID Numbers: 4R44DK103519-02 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes