Using an API to Commercialize an Evidence-Based Weight Loss Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Weight change
时间窗: up to 12 months
Change in body weight over course of study
次要结局
- Blood Pressure(baseline, 3-, 6-, 12-months)
- Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)(baseline, 3-, 6-, 12-months)
- The Health and Work Performance Questionnaire (HPQ)(baseline, 3-, 6-, 12-months)
- Automated Self-Administered 24-hour Dietary recall (ASA-24)(baseline, 3-, 6-, 12-months)
- Physical Activity(baseline, 3-, 6-, 12-months)
- Fasting Lipid Profile(baseline, 3-, 6-, 12-months)
- Questionnaire of Eating and Weight Patterns(baseline, 3-, 6-, 12-months)
- High Sensitivity C-Reactive Protein(baseline, 3-, 6-, 12-months)
- Patient Health Questionnaire (PHQ) 9(baseline, 3-, 6-, 12-months)
- Medical Outcomes Survey: Social Support(baseline, 3-, 6-, 12-months)
- Plasma Glucose(baseline, 3-, 6-, 12-months)
- Weight Change - 3 months(up to 3 months)
- Weight Change - 6 months(up to 6 months)
- Body Shape Questionnaire (BSQ)(baseline, 3-, 6-, 12-months)
- EuroQOL Health Related Quality of Life Scale(baseline, 3-, 6-, 12-months)
- App engagement(through study completion, an average of 1 year)