Using an API to Commercialize an Evidence-Based Weight Loss Intervention
- Conditions
- Health BehaviorWeight Loss
- Interventions
- Behavioral: API AppBehavioral: Non-API AppBehavioral: fitness trackerBehavioral: scale
- Registration Number
- NCT02812264
- Lead Sponsor
- Coeus Health, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attention Control scale use of non-API app for weight loss over 12 months, plus fitness tracker and scale. API App API App use of API weight loss mobile application for 12 months, plus fitness tracker and scale. API App scale use of API weight loss mobile application for 12 months, plus fitness tracker and scale. API App fitness tracker use of API weight loss mobile application for 12 months, plus fitness tracker and scale. Attention Control fitness tracker use of non-API app for weight loss over 12 months, plus fitness tracker and scale. Attention Control Non-API App use of non-API app for weight loss over 12 months, plus fitness tracker and scale.
- Primary Outcome Measures
Name Time Method Weight change up to 12 months Change in body weight over course of study
- Secondary Outcome Measures
Name Time Method Automated Self-Administered 24-hour Dietary recall (ASA-24) baseline, 3-, 6-, 12-months Dietary patterns/24-hour dietary recall
Physical Activity baseline, 3-, 6-, 12-months Paffenbarger survey to capture physical activity patterns. Assesses self-report leisure time physical activity and weekly kilocalorie expenditure.
Fasting Lipid Profile baseline, 3-, 6-, 12-months finger stick blood samples will be collected, following an overnight fast, to analyze fasting lipid profile. Samples will be analyzed using the Cholestech LDX
Questionnaire of Eating and Weight Patterns baseline, 3-, 6-, 12-months Eight-item self-report measure of binge eating behaviors.
Blood Pressure baseline, 3-, 6-, 12-months 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.
Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R) baseline, 3-, 6-, 12-months 24-item self-report measure of disordered eating cognitions.
The Health and Work Performance Questionnaire (HPQ) baseline, 3-, 6-, 12-months Presenteeism/Absenteeism items from the self-report HPQ.
High Sensitivity C-Reactive Protein baseline, 3-, 6-, 12-months 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 baseline, 3-, 6-, 12-months Nine-item self-report assessment of depression severity.
Medical Outcomes Survey: Social Support baseline, 3-, 6-, 12-months 19-item self-report assessment of social support.
Plasma Glucose baseline, 3-, 6-, 12-months finger stick blood samples will be collected, following an overnight fast, to analyze plasma glucose. Samples will be analyzed using the Cholestech LDX
Weight Change - 3 months up to 3 months Initial weight change
Weight Change - 6 months up to 6 months mid-point weight change
Body Shape Questionnaire (BSQ) baseline, 3-, 6-, 12-months 8-item self-report questionnaire about concern with body shape.
EuroQOL Health Related Quality of Life Scale baseline, 3-, 6-, 12-months 16-item self-report assessment of health related quality of life.
App engagement through study completion, an average of 1 year Using technology on smart phones, we will monitor participants' app usage throughout the course of the study.
Trial Locations
- Locations (1)
Coeus Health Offices
🇺🇸State College, Pennsylvania, United States