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临床试验/NCT04044794
NCT04044794已完成不适用

Daily Self-Weighing for Obesity Management in Primary Care

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2020年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
396
试验地点
1
主要终点
Change in body weight from baseline to month 18

研究概览

简要总结

Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.

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
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 19-65 years
  • Body mass index (BMI) 30 - 50 kg/m2
  • Receives care at one of the participating primary care clinics
  • Resides in one location at least 5 days each week
  • Possesses a smartphone with data plan
  • Wi-Fi or Bluetooth internet connection in home

排除标准

  • Pregnancy or anticipating pregnancy during study duration. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
  • Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments
  • Likely to relocate and no longer be seen at UAB primary care in the next 2 years
  • Weight loss ≥5% of body weight in past 6 months (other than postpartum)
  • Weight >180 kg (396lbs) due to the limitation of the scale being used.
  • Current participation in another weight loss study
  • Bariatric surgery or revision in the past two years
  • Prescription weight loss medications within the past 6 months
  • Another household member already participating in the study
  • Potential participants living farther than 50 miles driving distance from UAB will be excluded from the study. It is expected that those living farther away will be more difficult to retain as study participants.

结局指标

主要结局

Change in body weight from baseline to month 18

时间窗: 18 months

Body weight measured to the nearest 0.1 kg using a calibrated electronic scale

Change in body weight from baseline to month 6

时间窗: 6 months

Body weight measured to the nearest 0.1 kg using a calibrated electronic scale

Change in body weight from baseline to month 12

时间窗: 12 months

Body weight measured to the nearest 0.1 kg using a calibrated electronic scale

Change in body weight from baseline to month 24

时间窗: 24 months

Body weight measured to the nearest 0.1 kg using a calibrated electronic scale

次要结局

  • Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24(month 18 to month 24)
  • Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12(month 6 to month 12)
  • Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6(baseline to month 6)
  • Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18(month 12 to month 18)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gareth R. Dutton PhD

Professor

University of Alabama at Birmingham

研究点 (1)

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