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

Coeus Health

Status: Completed

Conditions: Weight Loss; Health Behavior

Treatments: Behavioral: scale; Behavioral: Non-API App; Behavioral: API App; Behavioral: fitness tracker

Study type: Interventional

Funder types: Industry

Identifiers

NCT02812264

4R44DK103519-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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209 participants in 2 patient groups

API App

Experimental group

Description:

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

Treatment:

Behavioral: fitness tracker

Behavioral: API App

Behavioral: scale

Attention Control

Active Comparator group

Description:

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

Treatment:

Behavioral: fitness tracker

Behavioral: Non-API App

Behavioral: scale