Noom Health for Weight Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in Weight From Baseline
研究概览
简要总结
The goals of the study are to use the Noom mobile app to help individuals with weight loss and weight loss maintenance. This project will test the comparative efficacy of Noom Health vs. Noom Digital Health for weight loss, quality of life, psychosocial functioning, and self-reported health status. It is expected that use of Noom Health will show post-intervention success relative to Noom Digital Health as well as long-term success with weight loss maintenance. Data is expected to show that participants who are older, have less support, have more health conditions, and with more psychosocial problems will benefit more from Noom Health. It is also expected that confidence in the ability to lose weight will produce more successful results in Noom Health vs. Noom Digital Health.
详细描述
A total of 600 subjects will be enrolled in a randomized-controlled trial comparing the Noom app (Noom Health) to a digital control (Noom Digital Health) with 6 months of intervention and 6 months active maintenance in both groups. Measures will include demographics, psychosocial measures, height/weight, waist circumference, weight loss history/practices, health care practices/utilization, and quality of life.
Participants will complete informed consent and interviews via a HIPAA-compliant videoconference (Zoom) and other questionnaires via a REDCap interface. All participants will complete screening/baseline procedures to determine eligibility and initial information. Subsequently, they will be randomized to one of the groups for a 6-month intervention and 6- month maintenance period (12 months total).
In Noom Health, participants will be encouraged to use the app multiple times per day to log eating episodes, physical activity and weight. Coaches will also interact with participants directly through the app. In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.
During the intervention, participants will complete monthly satisfaction surveys. Additionally, follow-up measures will be conducted at 7 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months).
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be interested in the Noom app
- •BMI > 27 kg/m2
- •Ages of 18 and 60 at entry to the study
- •Speak English
排除标准
- •Contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a smartphone)
- •Acute suicide risk
- •Pregnant or planning to become pregnant during the study
- •Current Noom use
结局指标
主要结局
Change in Weight From Baseline
时间窗: Baseline, 6 months and 30 Months
Weight at 6 months and 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale.
次要结局
- Percent of Successful Technological Fixes(Baseline and 12 Months)
- Change in CDC NCHS National Health Interview Survey(Baseline and 30 Months)
- Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months(Baseline and 30 Months)
- Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months(Baseline and 30 Months)
- Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months(Baseline and 30 Months)
- Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months(Baseline and 30 Months)
- Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months(Baseline and 30 Months)
- Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months(Baseline and 30 Months)
- Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months(Baseline and 30 Months)
- Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months(Baseline and 30 Months)
- Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months(Baseline and 30 Months)
- Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months(6 Months)
- Number of Participants With 12-Month Completion Status(12 Months)
- Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months(Baseline and 30 Months)
- Percent of Successful Technological Fixes(Baseline and 12 Months)
- Change in CDC NCHS National Health Interview Survey(Baseline and 30 Months)
研究者
Tom Hildebrandt
Associate Professor and Chief of the Division of Eating & Weight Disorders
Icahn School of Medicine at Mount Sinai