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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Health Behavior
• Intervention / Treatment: Behavioral: API App; Behavioral: fitness tracker; Behavioral: scale; Behavioral: Non-API App

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 Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Coeus Health Offices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: wearable; Behavioral: scale; Connected scale that will transfer weight information to app; Other Names: weight
Active Comparator: Attention Control; use of non-API app for weight loss over 12 months, plus 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 Names: wearable; Behavioral: scale; Connected scale that will transfer weight information to app; Other Names: weight; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Change in body weight over course of study	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change - 3 months	Initial weight change	up to 3 months
Weight Change - 6 months	mid-point weight change	up to 6 months
Automated Self-Administered 24-hour Dietary recall (ASA-24)	Dietary patterns/24-hour dietary recall	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.	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.	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	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	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	baseline, 3-, 6-, 12-months
Patient Health Questionnaire (PHQ) 9	Nine-item self-report assessment of depression severity.	baseline, 3-, 6-, 12-months
Body Shape Questionnaire (BSQ)	8-item self-report questionnaire about concern with body shape.	baseline, 3-, 6-, 12-months
Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)	24-item self-report measure of disordered eating cognitions.	baseline, 3-, 6-, 12-months
Questionnaire of Eating and Weight Patterns	Eight-item self-report measure of binge eating behaviors.	baseline, 3-, 6-, 12-months
Medical Outcomes Survey: Social Support	19-item self-report assessment of social support.	baseline, 3-, 6-, 12-months
EuroQOL Health Related Quality of Life Scale	16-item self-report assessment of health related quality of life.	baseline, 3-, 6-, 12-months
The Health and Work Performance Questionnaire (HPQ)	Presenteeism/Absenteeism items from the self-report HPQ.	baseline, 3-, 6-, 12-months
App engagement	Using technology on smart phones, we will monitor participants' app usage throughout the course of the study.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Coeus Health, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 4R44DK103519-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No