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临床试验/NCT04784624
NCT04784624Unknown不适用

Virtual Lifestyle Programming to Limit Collateral Health Damage From COVID 19 Pandemic: an Evaluation

University of Manitoba1 个研究点 分布在 1 个国家入组 100 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Program adherence

研究概览

简要总结

This is a pilot study evaluating an online cardiometabolic and weight loss program which is offered by The Wellness Institute. The program is 16 weeks and is developed by a multidisciplinary team and delivered by a degreed health professional (health coach) to assist participants in achieving their personal wellness goals. This study will also investigate the impact of Coronavirus Disease (COVID-19) on participants lifestyles and access to lifestyle programs and supports.

详细描述

The Wellness Institute is offering a new cardiometabolic and weight loss program. It is a digital behavior change program designed to help clients achieve healthy weight reduction, thereby improving cardiometabolic risk. The target population is overweight or obese individuals at risk for or living with health conditions such as pre-diabetes, diabetes, hypertension and high cholesterol. The purpose of this study is to evaluate the program following a mixed methods quasi-experimental approach using focus groups, questionnaires, and data collected over the 16 week duration of the program. Participants will be asked to fill in a set of questionnaires to measure physical activity, diet, sleep and stress at the start and end of the program. Other outcomes include changes in body weight, body mass index (BMI), blood pressure, clinical chemistry, and medication intake over the 16 week program. At the end of the program, adherence will be measured though attendance and platform usage and acceptability will be measured by an exit questionnaire and virtual focus groups. This study will investigate the impact of COVID-19 on participants lifestyles and access to lifestyle programs and support. The impact of COVID-19 will be assessed through a Covid-19 questionnaire and virtual focus groups.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Program adherence

时间窗: 16 weeks

Participants will be qualified as adhering to the program if they attend a minimum of 3 out of 4 health coaching sessions and have at least 1 activity during weeks 12-18.

Impact of COVID-19 survey

时间窗: Start of the program - first week of enrollment

A COVID-19 wellbeing survey will be used to understand the impact of COVID-19 pandemic on lifestyle behaviours and programs and services have changed in response to COVID-19

次要结局

  • Insulin(16 weeks)
  • Dietary intake(16 weeks)
  • Low-density lipoprotein cholesterol (LDL-C)(16 weeks)
  • Triglycerides(16 weeks)
  • Total cholesterol/HDL ratio(16 weeks)
  • Total cholesterol(16 weeks)
  • Systolic blood pressure(16 weeks)
  • Cardiovascular assessment(16 weeks)
  • Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L)(16 weeks)
  • Dietary habits(16 weeks)
  • Stress(16 weeks)
  • Program acceptability - exit survey(Program completion at 16 weeks)
  • Dietary behavior(16 weeks)
  • Sleep(16 weeks)
  • Hemoglobin A1C(16 weeks)
  • BMI(16 weeks)
  • Medication intake(16 weeks)
  • Physical activity level - International Physical Activity Questionnaire-Short (IPAQ-S)(16 weeks)
  • High-density lipoprotein Cholesterol (HDL-C)(16 weeks)
  • Fasting blood glucose(16 weeks)
  • Body weight(16 weeks)
  • Diastolic blood pressure(16 weeks)
  • Impact of COVID-19-focus groups(First 3 months of program initiation)
  • Program acceptability - focus groups(Within 3 months of completing the program)
  • Evaluate participant's program engagement and learning(At the end of the study)

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Claudio Rigatto

Associate professor

University of Manitoba

研究点 (1)

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标识符

NCT 编号
NCT04784624
其他研究编号
HS24424(H2020:495)

日期

首次提交
(5年前)
首次发布
(5年前)
主要完成日期
(4年前)
研究完成日期
(4年前)
最近核实
最近更新
(4年前)

监管与共享

FDA 监管药物
否
是否有结果
否

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