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Evaluation of a Commercial Program on Weight Loss and Health Outcomes 2

2018年4月3日 更新者:Renee J. Rogers、University of Pittsburgh

There is a body of evidence that has evaluated the effect of Weight Watchers, a commercially available weight loss program, on changes in body weight. The current investigation aims to add to this body of evidence by providing additional data on changes in body weight and enhance the current evidence-base in regards to evaluating other health-related outcomes.

There is little evidence that demonstrates whether or not the weight loss as a result of the Weight Watchers program elicits changes in health-related functional outcomes such as aerobic capacity, flexibility, sleep, and other psychological measures. Additionally, within a scientific research protocol, measures of adherence and satisfaction will also be evaluated evaluated. This study will evaluate these outcomes beyond weight changes achieved across the 24-week program.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15261
        • University of Pittsburgh

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male or female ages 18-75 years. Set "soft quotas" on the number of male and female participants. The desire is to have an 80% female/20% male split.
  • Willing to enroll in the Weight Watchers Program
  • With or without previous Weight Watchers experience Set maximum quota on the number of participants with previous Weight Watchers experience at 65%.
  • Self-reported height/weight resulting in a Body Mass Index (BMI) of 25 to 43 (will re-screen at facility).
  • Self report that he/she feels the need to lose weight.
  • Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement.
  • Willing to follow recommendations required by study protocol.
  • Willing to include demographic information (e.g., ethnicity, income and education).
  • Use of a personal iPhone on a daily basis

    1. iPhone must have iOS 8.0 or later
    2. Must have at least 600 MB of available storage to accommodate the size of the app
  • The willingness and ability to navigate and use applications on their iPhone on a daily basis (minimum training will be provided)
  • Reliable home Wi-Fi access
  • Ability to commit to attending up to 27 study visits in approximately 26 weeks:

    1. Ability to commit (to best of their ability) to attending weekly meetings, 30-60 minutes in duration, on the same day and at the same time each week for 24 consecutive weeks.
    2. Ability to commit to up to 3 additional study visits at Weeks 0, 12 and 24, with each visit being 60-90 minutes in duration to complete assessments (height, weight, questionnaires, physical measures).

Exclusion Criteria:

  • Currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs such as 5-2, or Atkins) or a structured weight-loss program (e.g., at a medical center, university, commercial programs)
  • A member of Weight Watchers within the past 12 months.
  • Involved in any other related research studies and self-report agreeing to not enroll in other studies that may affect weight or health outcomes over the next 12 months.
  • Pregnant or nursing, or planning on becoming pregnant over the next 9 months.
  • Weight loss of ≥ 5 kg in the previous 6 months.
  • History of clinically diagnosed eating disorder.
  • Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
  • Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
  • Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of Selective Serotonin Reuptake Inhibitors (SSRIs) for 6 months
  • Diuretic use for hypertension over 1.5mg per day
  • Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome acceptable).
  • History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
  • Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
  • Diagnosis of type 1 or type 2 diabetes.
  • Previous surgical procedure for weight loss.
  • Major surgery within the previous 6 months.
  • Presence of implanted cardiac defibrillator or pacemaker.
  • History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
  • Hospitalization for psychiatric problems during the past 12 months.
  • Consuming more than 14 alcoholic drinks per week or not more than 3 drinks per day.
  • Planning to relocate in the next 9 months.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention
Weight Watchers Intervention
Weight Watchers Intervention

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Body Weight Change
大体时间:Baseline, 3 months, and 6 months
To examine the effect of a 24-week commercially available weight loss program on weight change.
Baseline, 3 months, and 6 months

次要结果测量

结果测量
措施说明
大体时间
Change in Aerobic Capacity
大体时间:Baseline, 3 months, and 6 months
Aerobic Capacity: Participants will complete a 6 minute walk test on a designated walking course. The 6 minute walk test is a measure of functional and aerobic capacity. Participants will asked to walk at a brisk, yet comfortable pace for a total of 6 minutes.
Baseline, 3 months, and 6 months
Change in Flexibility
大体时间:Baseline, 3 months, and 6 months
Flexibility: Lower body flexibility will be assessed through the sit and reach test. The sit and reach is a common test to measure lower back and lower body flexibility.
Baseline, 3 months, and 6 months
Change in Sleep Quality and Duration
大体时间:Baseline, 3 months, and 6 months
Sleep quality and duration. Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) at baseline, Months 3 and 6. The PSQI is a validated self-report measure of sleep duration and sleep quality.
Baseline, 3 months, and 6 months
Change in Happiness
大体时间:Baseline, 3 months, and 6 months
Participants will be asked to complete the Oxford Happiness Questionnaire at baseline, Months 3 and 6. The OHQ is a validated self-report measure for broad personal happiness. Respondents rate 29 sentences on a 6 point Likert scale (1, strongly disagree; 6, strong agree).
Baseline, 3 months, and 6 months
Change in Food Cravings
大体时间:Baseline, 3 months, and 6 months
The Food Craving Inventory-II (FCI-II) is a validated self-report measure for general cravings and cravings for specific types of foods and will be completed at baseline, Months 3 and 6. Respondents rate the frequency of cravings since the last time they completed the survey for each of 33 food items using a five-point Likert scale (1, never; 2, rarely; 3, sometimes; 4, often; 5, always/almost every day). The FCI-II consists of 5 scales (sweets, high fats, carbohydrates/starches, fast food fats, and fruits & vegetables) that constitute the higher order construct of food cravings (the total score).
Baseline, 3 months, and 6 months
Program Adherence
大体时间:Baseline, 3 months, and 6 months
Data on adherence (attendance at meetings and use of the points system) will also be collected. Attendance data will be recorded by Weight Watchers staff at every meeting. These data will be confirmed by a member of the research staff that will be attending the weekly Weight Watchers meetings. In addition, the weekly weights obtained at the intervention sessions will be provided to the investigators by the intervention staff to allow for examination of the trajectory of weight loss.
Baseline, 3 months, and 6 months
Program Satisfaction
大体时间:3 months and 6 months

Program Satisfaction:

Participants will be asked to complete a program Satisfaction Survey. The Satisfaction Survey is a self-administered survey scored on a 5-point Likert scale.

3 months and 6 months
Program Satisfaction - Open-ended Survey
大体时间:6 months

Program Satisfaction:

Open-ended Satisfaction Survey. Participants will be asked to complete a Open-ended Satisfaction survey that consist of 2 open-ended questions, and asked respondents to report on their satisfaction with the program.

6 months
Change in Weight-related Quality of Life
大体时间:Baseline, 3 months, and 6 months
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life and will be completed at baseline, Months 3 and 6. Respondents rate the degree to which their weight affects them on 31 items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4, usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function, self-esteem, sexual life, public distress, and work).
Baseline, 3 months, and 6 months
Change in Hunger
大体时间:Baseline, 3 months, and 6 months
The most commonly used tool to measure subjective sensations of hunger is the Visual Analogue Scale (VAS). A VAS measures sensations that range across a continuum of values and cannot be easily directly measured. Operationally, the VAS is a horizontal line measuring exactly 100 mm in length, anchored by word descriptors (i.e., Not at all hungry, Extremely hungry) at each end. At baseline, Months 3 and 6, participants will be asked to complete a three item VAS by placing a mark on the line at the point they feel represents their response to the question.
Baseline, 3 months, and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Renee J. Rogers, Ph.D.、University of Pittsburgh

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月15日

初级完成 (实际的)

2017年9月18日

研究完成 (实际的)

2017年9月18日

研究注册日期

首次提交

2017年2月27日

首先提交符合 QC 标准的

2017年3月8日

首次发布 (实际的)

2017年3月14日

研究记录更新

最后更新发布 (实际的)

2018年4月4日

上次提交的符合 QC 标准的更新

2018年4月3日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PRO17010232

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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