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临床试验/NCT01646086
NCT01646086已完成不适用

Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care

University of Minnesota1 个研究点 分布在 1 个国家目标入组 339 人开始时间: 2012年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
339
试验地点
1
主要终点
Change in Body Weight Over Time

研究概览

简要总结

To achieve the long term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternative mode of care (no weight tracking).

The investigators postulate that daily weight tracking will boost ongoing awareness of and engagement in dietary intake and physical activity monitoring, thus improving weight loss outcomes. The central hypothesis of the study is that daily weight tracking will improve weight loss processes and outcomes relative to less frequent weight tracking, without adverse effects.

详细描述

Given the pernicious reach of obesity and the evidence that current behavioral treatments are modestly effective at changing weight, efforts to refine behavioral recommendations in order to improve weight loss interventions are crucial. Frequency of tracking body weight presents itself as a prime target for behavioral enhancement during weight loss. Daily self-monitoring (e.g., of dietary intake and physical activity) is already well-established as a central component of the behavioral weight loss process. However, the current standard of care in behavioral weight loss with regard to weighing is weekly tracking of weight, and some programs caution against any weight tracking. It has been suggested that frequent weight tracking may have a negative impact on mental health and outcomes during weight loss, but there are minimal data that address this concern experimentally in the context of an active weight loss program. Observational evidence from behavioral weight control trials and community studies suggests that greater frequency of tracking weight is associated with better weight outcomes. Stronger experimental evidence is needed to establish a causal link between weight tracking and weight outcomes and to elucidate the impact on mental health during weight loss. To achieve the long-term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternate model of care with very limited data (no weight tracking). In pursuit of study goals, 336 overweight and obese adults will be recruited and randomized to one of three 12-month weight loss interventions with a 12-month follow-up (24 months total time in study): the standard of care (weekly weight tracking during weight loss), an enhanced condition (daily weight tracking during weight loss), or a comparison condition (no weight tracking during weight loss). The rationale behind this proposal is that within the context of social ecology and a social-cognitive framework of behavior change, enhancement of this key environmental feature (i.e., the weight tracking environment) during weight loss will contribute to success by promoting self-efficacy for this critical behavior. Specific aims of the study will seek to determine the effects of weight tracking frequency on the weight loss process and outcomes, as well as to elucidate the effects of weight tracking frequency on mental health during weight loss. This study will have the expected outcome of enhancing the standard of care for weight loss, leading to better weight control for overweight and obese adults and thus directly mitigating the public health impact of the obesity crisis.

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 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •women and men
  • •18-64 years of age
  • •BMI between 25.0 and 39.9 kg/m2 (overweight to obese)
  • •interest in joining a weight loss program
  • •have a computer, email, and wifi connection at home
  • •live in the Minneapolis/Saint Paul, Minnesota area

排除标准

  • •weight in the underweight to low normal (BMI < 22) or morbidly obese (BMI > 35) ranges
  • •current eating disorder or history of eating disorders
  • •current major depression or psychotic disorder diagnosis
  • •current cardiovascular disease or diabetes diagnosis
  • •current participation in a weight loss program
  • •current pregnancy
  • •previous weight loss surgery

研究组 & 干预措施

weekly weight tracking

Experimental

12 month behavioral weight loss intervention

干预措施: 12 month behavioral weight loss intervention (Behavioral)

daily weight tracking

Active Comparator

12 month behavioral weight loss intervention

干预措施: 12 month behavioral weight loss intervention (Behavioral)

no weight tracking

Active Comparator

12 month behavioral weight loss intervention

干预措施: 12 month behavioral weight loss intervention (Behavioral)

结局指标

主要结局

Change in Body Weight Over Time

时间窗: baseline, 6 months, 12 months, 18 months, and 24 months

Weight (in kilograms) will be measured by study staff using a calibrated digital scales with participants wearing light clothing and no shoes. Height (in centimeters) will be measured by study staff at baseline only using a portable stadiometer. BMI (kg/m2) will be calculated from these measurements

次要结局

  • Weight Tracking and Self-Monitoring Adherence(throughout intervention)
  • Routine Health Habits(baseline, 12 months, and 24 months)
  • Dietary Intake(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Body Image(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Self-Esteem(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Anxiety(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Demographic Measures(baseline)
  • Self-Efficacy for Weight Loss Behaviors(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Barriers to Weight Tracking(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Depression(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Mood States(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Perceptions of Weight Tracking(6 months, 12 months, 18 months, and 24 months)
  • Eating Disorder Symptoms(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Physical Activity(baseline, 6 months, 12 months, 18 months, and 24 months)
  • Life Events(baseline, 12 months, and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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