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临床试验/NCT06963736
NCT06963736招募中不适用

WatchWell: Simple and Practical Strategies to Reduce the Negative Health Impact of Sedentary Screen Time

Arizona State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Changes in Evening Sedentary Screen Time

研究概览

简要总结

The purpose of this study is to determine the feasibility, acceptability, efficacy, and participant adherence in using home-based technologies and wearable devices and simple, practical strategies to reduce the negative impact that evening screen time may have on your health.

详细描述

Sedentary screen time (SST) is the most common discretionary activity among all US age and race/ethnic groups. SST is associated with poor health outcomes, including cardiovascular disease (CVD). Recreational SST (rSST) is 2-3X more detrimental to health than other forms of sedentary behavior (e.g., workplace sitting, traveling). Elucidating the mechanisms that lead to elevated harm resulting from rSST is critical. Impact of the COVID-19 pandemic to increase rSST amplifies the urgency of understanding rSST-related mechanisms that lead to detrimental health outcomes. Previous SST studies are limited in scope of intervention and outcomes. There are vital gaps in knowledge about how rSST and rSST-associated behaviors lead to increased CVD risk. Interventions applied in ecologically valid, real-world settings are urgently needed to develop the most potent interventions that address and attenuate critical mechanistic pathways that mediate rSST-associated health risks. WatchWell is a pilot study designed to achieve three important goals that will support our obtaining funding for this research and is responsive to reviewer comments on our previously submitted NIH/NHLBI P01 Program Project: 1) demonstrate feasibility and participant acceptability of study design 2) demonstrate participant acceptability of measurement devices; 3) generate preliminary data to estimate outcome effect sizes.

In the course of WatchWell, the team of investigators will intervene on 3 behavioral mechanisms that are likely primary drivers of dSST CVD risk based on their prominent co-occurrence with rSST and individual contributions to CVD risk: blue light at night, nighttime food intake and prolonged evening sitting time. The investigators hypothesize that these 3 behavioral mechanisms impact CVD risk via downstream biological mechanisms including diurnal sleep/wake and body temperature rhythms, glucose metabolism, and autonomic balance (including heart rate variability, HRV). These biological mechanisms have not been assessed concurrently nor in the real-time, real-world context of rSST-related behaviors.

For this WorkWell pilot, the team of investigators will test 2 of the 3 behavioral mechanisms compared to the baseline control condition per participant using a 3-condition randomized controlled crossover design. [In the full trial to be resubmitted to the NIH, we will conduct a 4-condition crossover RCT, testing all 3 behavioral mechanisms compared to the baseline control condition per participant.] The investigators will recruit adults with overweight and at least 2 criteria of the metabolic syndrome (goal of N=18 completers, up to 30 enrollees total), who have elevated CVD risk. Impact. Recreational SST is a highly prevalent, modifiable risk factor for CVD. WorkWell will be the first to intervene on rSST-associated evening/nighttime blue light, food intake, and prolonged sitting in a real-world setting and to concurrently measure downstream CVD-related biological mechanisms. The WorkWell study design is informed by and will contribute to the translational application of circadian biology.

Aim 1. Assess the study feasibility and participant acceptability of delivering three behavioral strategies (avoiding dietary intake after 8p; blocking blue-light exposure after 8p; and breaking up prolonged sitting with standing after 5p) to reduce negative health exposures associated with rSST over two-week conditions in a randomized crossover study design.

Aim 2. Assess protocol compliance and participant acceptability of a suite of wearable sensors and home-based technologies during the feasibility trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •≥26 years of age
  • •BMI ≥ 27 kg/m2*; ≥25 kg/m2, if Asian (full or multiple race)**
  • •Insufficiently active (per US National Guidelines for Physical Activity of 150 minutes of MVPA/Week)
  • •Reporting an average of ≥3 hours of recreational sedentary screen time (rSST) per day, that usually extends at least until 9:00pm.
  • •On a typical night, consumes calories (food and/or drink) after 8:00pm.
  • •Meet at least 2 criteria for metabolic syndrome
  • •Central adiposity: waist circumference >40 inches (men); >35 inches (women)
  • •Elevated blood pressure: SBP >130 mmHg and/or DBP >85 mmHg OR controlled with medication
  • •Low high density lipoprotein (HDL) cholesterol: <40 mg/dL (men); <50 mg/dL (women)
  • •Elevated triglycerides: >150 mg/dL OR controlled with medication
  • •Elevated fasting glucose: ≥100 mg/dL OR controlled with medication

排除标准

  • •Conditions related to sleep disruption, including lactation, pregnancy, mid-night care providers, sleep disorders, severe sleep apnea
  • •History of hypoglycemia
  • •Pacemaker
  • •Caffeine consumption in excess and/or after 5pm (excess equals >4 cups of coffee per day or equivalent)
  • •Involvement in other physical activity, diet, or weight loss programs/studies
  • •Weight change of 5% up or down in the last three months.
  • •Drug abuse
  • •THC use (smoking, edibles)
  • •Excessive alcohol use (for women, 8 or more drinks per week; for men, 15 or more drinks per week)
  • •Current smoker or user of any nicotine source - any amount or form (vapor/e-cig/tobacco/patch, gum, etc.)
  • •Medications that markedly impact glucose metabolism and sleep (insulin, corticosteroids, growth hormone, melatonin)
  • •Previous or current diagnosis of a clinical eating disorder (e.g., night eating syndrome, anorexia, bulimia, binge eating disorder); or self-report eating disorder behaviors
  • •Unstable or poorly controlled blood glucose (e.g., hypoglycemia, fasting glucose greater than 125 mg/dL)
  • •Chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease)
  • •Shift work
  • •Recent or upcoming jetlag (travel 3 months prior and during study that is >1 time zone away from Arizona)
  • •Current practice of evening and nighttime blue light blocking.
  • •Poorly controlled hypertension (SBP ≥165 or DBP ≥100)
  • •Any condition or circumstance that would prevent compliance to the protocol
  • •Use non-android phone as their primary/personal phone

研究组 & 干预措施

Standing-Blue Light

Experimental

Intervention 1: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.

Intervention 2: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.

干预措施: Standing (Behavioral)

Standing-Eating

Experimental

Intervention 1: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.

Intervention 2: Participants will be encouraged to stop eating at 8pm.

干预措施: Eating (Behavioral)

Standing-Eating

Experimental

Intervention 1: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.

Intervention 2: Participants will be encouraged to stop eating at 8pm.

干预措施: Standing (Behavioral)

Blue light-Eating

Experimental

Intervention 1: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.

Intervention 2: Participants will be encouraged to stop eating at 8pm.

干预措施: Blue light (Behavioral)

Blue light-Eating

Experimental

Intervention 1: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.

Intervention 2: Participants will be encouraged to stop eating at 8pm.

干预措施: Eating (Behavioral)

Blue light-standing

Experimental

Intervention 1: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.

Intervention 2: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.

干预措施: Blue light (Behavioral)

Blue light-standing

Experimental

Intervention 1: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.

Intervention 2: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.

干预措施: Standing (Behavioral)

Eating-Standing

Experimental

Intervention 1: Participants will be encouraged to stop eating at 8pm. Intervention 2: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.

干预措施: Eating (Behavioral)

Eating-Standing

Experimental

Intervention 1: Participants will be encouraged to stop eating at 8pm. Intervention 2: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.

干预措施: Standing (Behavioral)

Eating-Blue Light

Experimental

Intervention 1: Participants will be encouraged to stop eating at 8pm. Intervention 2: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.

干预措施: Blue light (Behavioral)

Eating-Blue Light

Experimental

Intervention 1: Participants will be encouraged to stop eating at 8pm. Intervention 2: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.

干预措施: Eating (Behavioral)

Standing-Blue Light

Experimental

Intervention 1: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.

Intervention 2: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.

干预措施: Blue light (Behavioral)

结局指标

主要结局

Changes in Evening Sedentary Screen Time

时间窗: 2 weeks

Minutes per week of screen time after 5p as measured by WatchWell app and activPAL

Treatment acceptability

时间窗: 2 weeks

Intervention acceptability will be assessed using the Treatment Evaluation Questionnaire (TEQ) to measure acceptability of the three experimental conditions following the completion of each condition. Scale Range: 0 to 4. Higher scores indicate greater acceptability.

Change in evening postprandial glycemic control (5pm - 5am)

时间窗: 2 weeks

Participants will be asked to wear the Dexcom G6 Pro continuous glucose monitor during baseline and experimental conditions. Glycemic control will be calculated by averaging all glucose readings from 5pm - 5am during each of the conditions.

次要结局

未报告次要终点

研究者

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

Matthew P Buman, PhD

Professor

Arizona State University

研究点 (1)

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