Weight Loss, Health Behavior
Conditions
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.
Interventions
BEHAVIORALAPI App
Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale
BEHAVIORALNon-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.
BEHAVIORALfitness tracker
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
BEHAVIORALscale
Connected scale that will transfer weight information to app
Sponsors
Coeus Health, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants will not know which arm they have been randomized to. Additionally, the investigators will be blinded to participant assignment. Randomization will be completed by the program manager.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | up to 12 months | Change in body weight over course of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change - 6 months | up to 6 months | mid-point weight change |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| Weight Change - 3 months | up to 3 months | Initial weight change |
| Body Shape Questionnaire (BSQ) | baseline, 3-, 6-, 12-months | 8-item self-report questionnaire about concern with body shape. |
| Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R) | baseline, 3-, 6-, 12-months | 24-item self-report measure of disordered eating cognitions. |
| Questionnaire of Eating and Weight Patterns | baseline, 3-, 6-, 12-months | Eight-item self-report measure of binge eating behaviors. |
| Medical Outcomes Survey: Social Support | baseline, 3-, 6-, 12-months | 19-item self-report assessment of social support. |
| EuroQOL Health Related Quality of Life Scale | baseline, 3-, 6-, 12-months | 16-item self-report assessment of health related quality of life. |
| The Health and Work Performance Questionnaire (HPQ) | baseline, 3-, 6-, 12-months | Presenteeism/Absenteeism items from the self-report HPQ. |
| 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. |
| Patient Health Questionnaire (PHQ) 9 | baseline, 3-, 6-, 12-months | Nine-item self-report assessment of depression severity. |
Countries
United States
Outcome results
None listed