Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Physical Activity: Step Count
研究概览
简要总结
This early-phase trial will test intervention strategies to influence affective mechanisms underlying physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese.
详细描述
This ORBIT model phase 1 trial will examine whether affective mechanisms (1) can be experimentally manipulated in real-world settings; and (2) mediate the relationship between interventions and physical activity behavior. A novel physical activity intervention will be optimized by efficiently disentangling the effects of its core component and two enhancement components on affective mechanisms associated with physical activity engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 years
- •Reside in the United States
- •Self-reported BMI ≥ 25
- •Current structured physical activity engagement < 60 minutes per week
- •Own a personal smartphone device
- •Reside in an area with Internet or Wi-Fi connectivity during the study period
- •Able to speak and read in English
- •Interested and willing to start a physical activity program
- •Willing to wear a Fitbit Versa smartwatch provided by the study team everyday continuously (including at work and during physical activity), in place of any Fitbits or smartwatches previously worn, for the duration of the study period
- •Able to read the small font on a smartwatch screen without glasses, or willing to carry reading glasses during physical activity for the purpose of reading the smartwatch screen
排除标准
- •Inability to provide informed consent due to cognitive disability
- •Inability to engage in one or more key treatment components, including those with medical conditions that preclude physical activity engagement or who cannot wear an accelerometer on the wrist or answer brief surveys on the smartwatch for any reason
- •Current pregnancy
- •Referred to the study by another participant or from Reddit.
研究组 & 干预措施
Affect (no enhancements) > Intensity
Participants receive affect-based goals for the first 8-weeks, then cross-over to receive intensity-based goals for the second 8-weeks. No enhancements are added to the standard mHealth intervention.
干预措施: Physical Activity Goals mHealth Intervention (Behavioral)
Intensity > Affect (no enhancements)
Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. No enhancements are added to the standard mHealth intervention.
干预措施: Physical Activity Goals mHealth Intervention (Behavioral)
Affect (+ SAVOR + TYPE/CONTEXT) > Intensity
Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.
干预措施: TYPE/CONTEXT enhancement (Behavioral)
Affect (+ SAVOR + TYPE/CONTEXT) > Intensity
Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.
干预措施: SAVOR enhancement (Behavioral)
Affect (+ SAVOR + TYPE/CONTEXT) > Intensity
Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.
干预措施: Physical Activity Goals mHealth Intervention (Behavioral)
Intensity > Affect (+ SAVOR + TYPE/CONTEXT)
Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition.
干预措施: SAVOR enhancement (Behavioral)
Intensity > Affect (+ SAVOR + TYPE/CONTEXT)
Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition.
干预措施: Physical Activity Goals mHealth Intervention (Behavioral)
Intensity > Affect (+ SAVOR + TYPE/CONTEXT)
Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition.
干预措施: TYPE/CONTEXT enhancement (Behavioral)
Affect (+SAVOR) > Intensity
Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.
干预措施: Physical Activity Goals mHealth Intervention (Behavioral)
Affect (+SAVOR) > Intensity
Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.
干预措施: SAVOR enhancement (Behavioral)
Intensity > Affect (+SAVOR)
Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition.
干预措施: Physical Activity Goals mHealth Intervention (Behavioral)
Intensity > Affect (+SAVOR)
Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition.
干预措施: SAVOR enhancement (Behavioral)
Affect (+TYPE/CONTEXT) > Intensity
Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.
干预措施: TYPE/CONTEXT enhancement (Behavioral)
Affect (+TYPE/CONTEXT) > Intensity
Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks.
干预措施: Physical Activity Goals mHealth Intervention (Behavioral)
Intensity > Affect (+TYPE/CONTEXT)
Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition.
干预措施: Physical Activity Goals mHealth Intervention (Behavioral)
Intensity > Affect (+TYPE/CONTEXT)
Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition.
干预措施: TYPE/CONTEXT enhancement (Behavioral)
结局指标
主要结局
Physical Activity: Step Count
时间窗: Daily total for weeks 1-19
Daily steps will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis.
Physical Activity: Minutes
时间窗: Daily total for weeks 1-19
Daily minutes of light, moderate, and vigorous physical activity will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis.
次要结局
- Affective Response(Max 2 per 60-min physical activity period during weeks 2-9 and weeks 12-19)
- Affectively-Charged Motivations(Up to once daily for weeks 2-9 and weeks 12-19)
- Anticipated Affect(Up to once daily for weeks 2-9 and weeks 12-19)
研究者
Genevieve Dunton
Chief, Division of Health Behavior Research and Director, USC Real-Time Eating Activity and Children's Health (REACH) Lab
University of Southern California