Clinical trial NCT02812264: 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
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Health Behavior
Lead sponsor: Coeus Health, LLC
Sponsor class: INDUSTRY
First posted: 2016-06-24
Enrollment: 209
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight change
timeFrame: up to 12 months
Secondary outcomes:
measure: Weight Change - 3 months
timeFrame: up to 3 months
measure: Weight Change - 6 months
timeFrame: up to 6 months
measure: Automated Self-Administered 24-hour Dietary recall (ASA-24)
timeFrame: baseline, 3-, 6-, 12-months
measure: Physical Activity
timeFrame: baseline, 3-, 6-, 12-months
measure: Blood Pressure
timeFrame: baseline, 3-, 6-, 12-months
measure: Fasting Lipid Profile
timeFrame: baseline, 3-, 6-, 12-months
measure: Plasma Glucose
timeFrame: baseline, 3-, 6-, 12-months
measure: High Sensitivity C-Reactive Protein
timeFrame: baseline, 3-, 6-, 12-months
measure: Patient Health Questionnaire (PHQ) 9
timeFrame: baseline, 3-, 6-, 12-months
measure: Body Shape Questionnaire (BSQ)
timeFrame: baseline, 3-, 6-, 12-months
measure: Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)
timeFrame: baseline, 3-, 6-, 12-months
measure: Questionnaire of Eating and Weight Patterns
timeFrame: baseline, 3-, 6-, 12-months
measure: Medical Outcomes Survey: Social Support
timeFrame: baseline, 3-, 6-, 12-months
measure: EuroQOL Health Related Quality of Life Scale
timeFrame: baseline, 3-, 6-, 12-months
measure: The Health and Work Performance Questionnaire (HPQ)
timeFrame: baseline, 3-, 6-, 12-months
measure: App engagement
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: State College
country: United States
facility: Coeus Health Offices
state: Pennsylvania
Study officials:
References: