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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812264
• Other study ID #: 4R44DK103519-02
• Status: Completed
• Phase: N/A
• Start date: June 7, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: July 2020
• Source: Coeus Health, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Health Behavior
• Weight Loss

Intervention

Behavioral:
• API App
Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale
• 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.
• fitness tracker
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
• scale
Connected scale that will transfer weight information to app

Locations

Country	Name	City	State
United States	Coeus Health Offices	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Coeus Health, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change	Change in body weight over course of study	up to 12 months
Secondary	Weight Change - 3 months	Initial weight change	up to 3 months
Secondary	Weight Change - 6 months	mid-point weight change	up to 6 months
Secondary	Automated Self-Administered 24-hour Dietary recall (ASA-24)	Dietary patterns/24-hour dietary recall	baseline, 3-, 6-, 12-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Health Questionnaire (PHQ) 9	Nine-item self-report assessment of depression severity.	baseline, 3-, 6-, 12-months
Secondary	Body Shape Questionnaire (BSQ)	8-item self-report questionnaire about concern with body shape.	baseline, 3-, 6-, 12-months
Secondary	Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)	24-item self-report measure of disordered eating cognitions.	baseline, 3-, 6-, 12-months
Secondary	Questionnaire of Eating and Weight Patterns	Eight-item self-report measure of binge eating behaviors.	baseline, 3-, 6-, 12-months
Secondary	Medical Outcomes Survey: Social Support	19-item self-report assessment of social support.	baseline, 3-, 6-, 12-months
Secondary	EuroQOL Health Related Quality of Life Scale	16-item self-report assessment of health related quality of life.	baseline, 3-, 6-, 12-months
Secondary	The Health and Work Performance Questionnaire (HPQ)	Presenteeism/Absenteeism items from the self-report HPQ.	baseline, 3-, 6-, 12-months
Secondary	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