Using an API to Commercialize an Evidence-Based Weight Loss Intervention
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 2/1/2019 |
| Start Date: | June 7, 2017 |
| End Date: | December 2019 |
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.
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.
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.
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.
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
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