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

Primary Purpose

Weight Loss, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
API App
Non-API App
fitness tracker
scale
Sponsored by
Coeus Health, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Coeus Health Offices

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

API App

Attention Control

Arm Description

use of API weight loss mobile application for 12 months, plus fitness tracker and scale.

use of non-API app for weight loss over 12 months, plus fitness tracker and scale.

Outcomes

Primary Outcome Measures

Weight change
Change in body weight over course of study

Secondary Outcome Measures

Weight Change - 3 months
Initial weight change
Weight Change - 6 months
mid-point weight change
Automated Self-Administered 24-hour Dietary recall (ASA-24)
Dietary patterns/24-hour dietary recall
Physical Activity
Paffenbarger survey to capture physical activity patterns. Assesses self-report leisure time physical activity and weekly kilocalorie expenditure.
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.
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
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
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
Patient Health Questionnaire (PHQ) 9
Nine-item self-report assessment of depression severity.
Body Shape Questionnaire (BSQ)
8-item self-report questionnaire about concern with body shape.
Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)
24-item self-report measure of disordered eating cognitions.
Questionnaire of Eating and Weight Patterns
Eight-item self-report measure of binge eating behaviors.
Medical Outcomes Survey: Social Support
19-item self-report assessment of social support.
EuroQOL Health Related Quality of Life Scale
16-item self-report assessment of health related quality of life.
The Health and Work Performance Questionnaire (HPQ)
Presenteeism/Absenteeism items from the self-report HPQ.
App engagement
Using technology on smart phones, we will monitor participants' app usage throughout the course of the study.

Full Information

First Posted
June 10, 2016
Last Updated
July 13, 2020
Sponsor
Coeus Health, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02812264
Brief Title
Using an API to Commercialize an Evidence-Based Weight Loss Intervention
Official Title
Using an API to Commercialize an Evidence-Based Weight Loss Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coeus Health, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Health Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
API App
Arm Type
Experimental
Arm Description
use of API weight loss mobile application for 12 months, plus fitness tracker and scale.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
use of non-API app for weight loss over 12 months, plus fitness tracker and scale.
Intervention Type
Behavioral
Intervention Name(s)
API App
Intervention Description
Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale
Intervention Type
Behavioral
Intervention Name(s)
Non-API App
Intervention Description
Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.
Intervention Type
Behavioral
Intervention Name(s)
fitness tracker
Other Intervention Name(s)
wearable
Intervention Description
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
Intervention Type
Behavioral
Intervention Name(s)
scale
Other Intervention Name(s)
weight
Intervention Description
Connected scale that will transfer weight information to app
Primary Outcome Measure Information:
Title
Weight change
Description
Change in body weight over course of study
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Weight Change - 3 months
Description
Initial weight change
Time Frame
up to 3 months
Title
Weight Change - 6 months
Description
mid-point weight change
Time Frame
up to 6 months
Title
Automated Self-Administered 24-hour Dietary recall (ASA-24)
Description
Dietary patterns/24-hour dietary recall
Time Frame
baseline, 3-, 6-, 12-months
Title
Physical Activity
Description
Paffenbarger survey to capture physical activity patterns. Assesses self-report leisure time physical activity and weekly kilocalorie expenditure.
Time Frame
baseline, 3-, 6-, 12-months
Title
Blood Pressure
Description
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.
Time Frame
baseline, 3-, 6-, 12-months
Title
Fasting Lipid Profile
Description
finger stick blood samples will be collected, following an overnight fast, to analyze fasting lipid profile. Samples will be analyzed using the Cholestech LDX
Time Frame
baseline, 3-, 6-, 12-months
Title
Plasma Glucose
Description
finger stick blood samples will be collected, following an overnight fast, to analyze plasma glucose. Samples will be analyzed using the Cholestech LDX
Time Frame
baseline, 3-, 6-, 12-months
Title
High Sensitivity C-Reactive Protein
Description
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
Time Frame
baseline, 3-, 6-, 12-months
Title
Patient Health Questionnaire (PHQ) 9
Description
Nine-item self-report assessment of depression severity.
Time Frame
baseline, 3-, 6-, 12-months
Title
Body Shape Questionnaire (BSQ)
Description
8-item self-report questionnaire about concern with body shape.
Time Frame
baseline, 3-, 6-, 12-months
Title
Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)
Description
24-item self-report measure of disordered eating cognitions.
Time Frame
baseline, 3-, 6-, 12-months
Title
Questionnaire of Eating and Weight Patterns
Description
Eight-item self-report measure of binge eating behaviors.
Time Frame
baseline, 3-, 6-, 12-months
Title
Medical Outcomes Survey: Social Support
Description
19-item self-report assessment of social support.
Time Frame
baseline, 3-, 6-, 12-months
Title
EuroQOL Health Related Quality of Life Scale
Description
16-item self-report assessment of health related quality of life.
Time Frame
baseline, 3-, 6-, 12-months
Title
The Health and Work Performance Questionnaire (HPQ)
Description
Presenteeism/Absenteeism items from the self-report HPQ.
Time Frame
baseline, 3-, 6-, 12-months
Title
App engagement
Description
Using technology on smart phones, we will monitor participants' app usage throughout the course of the study.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Coeus Health Offices
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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