Six-Month Randomized Controlled Trial of Text-Based Mobile Health and Wellness Coaching for Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Weight
研究概览
简要总结
The objective of this study was to assess the effectiveness of a 6-month text-based mobile health and wellness (mHWC) intervention, as compared to usual care (UC), for weight loss in adults. Participants were randomly assigned to one of the two groups (mHWC or UC). At the beginning of the study, both groups were given a Fitbit wearable device, and a weight scale. All participants also received a counseling session from a dietician focused on diet, physical activity, and sleep, and were set up on the Nudge app, a commercially-available mHWC platform. Participants in the mHWC group received text-based coaching messages via Nudge and did not return to the clinic for the duration of the 6-month intervention. Those in the UC group met once a month with a pharmacist or dietician for 6 months. In both groups, the focus was on facilitating health behavior change related to diet, physical activity, and sleep to promote weight loss.
We hypothesized that weight loss at 6 months would be greater in the mHWC group vs. the UC group.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥27 kg/m^2
- •Waist circumference ≥35 inches (women) or ≥40 inches (men)
- •Own an Android smartphone or iPhone capable of running the Nudge and Fitbit applications.
- •Indicate sending at least one text-based (e.g., SMS, Facebook, Twitter) message via their smartphone on most days
排除标准
- •Pacemaker or other electronic implant
- •Weight ≥400 pounds
- •Weight loss ≥5% of bodyweight in previous 6 months
- •High cardiovascular risk, as determined by Physical Activity Readiness Questionnaire (PAR-Q) and physician review, as needed.
结局指标
主要结局
Change in Weight
时间窗: 6 months (mean 193 ± 21 days)
Assessed at baseline and follow-up
次要结局
- Change Waist Circumference(6 months (mean 193 ± 21 days))
- Change in Self-Reported Sleep Quantity(6 months (mean 193 ± 21 days))
- Change in Self-Reported Physical Activity(6 months (mean 193 ± 21 days))
- Change in Self-Reported Daily Caloric Consumption(6 months (mean 193 ± 21 days))