Physical Activity for Sedentary Lifestyle

Overseen By Rebecca E Hasson, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Iron, Metformin, Chemotherapy

Disqualifiers: Uncontrolled asthma, Heart condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Adherence refers to how well a person follows a recommended and agreed-upon course of action. Adherence is necessary for desired clinical outcomes and can include attending appointments, making lifestyle changes, and following home-based regimens for themselves or someone for whom they care for. Adherence to home exercise programs can be as low as 50%, directly impacting program effectiveness. There are many reasons why an individual may struggle to adhere, which may include perceived barriers such as not having enough time, reduced self-efficacy, the belief that the program is ineffective, or seeing early positive results so they then feel they do not need to continue with the program. For children, low skill level and lack of parental support are additional barriers to program adherence. A Sequential Multiple Assignment Randomized Trial (SMART) intervention is an intervention design that guides the adaptation of treatments over time. Adaptation refers to the use of dynamic information about a person (or family) to decide whether and how to intervene. SMART interventions are intended to address the unique and changing needs of individuals. The proposed study will examine the feasibility of using a 12-week (60-day) adaptive intervention design to optimize child adherence to a home exercise program. To advance equitable adherence to home exercise programs, there is a pressing need to develop strategies that support all children and families. The proposed study will provide new knowledge regarding the utility of adaptive interventions to optimize participation engagement in behavioral interventions in community contexts.

Do I have to stop taking my current medications to join the trial?

Yes, if you are currently taking medications like iron, metformin, or chemotherapeutic agents that could impact your ability to engage in physical activity, you will not be eligible to participate in the trial.

What data supports the idea that Physical Activity for Sedentary Lifestyle is an effective treatment?

The available research shows that interrupting prolonged sitting with physical activity can be beneficial for health. For example, a study on overweight and obese adults found that breaking up sitting time was feasible and could be measured effectively. Another study focused on older adults, who tend to sit the most, and explored different strategies to interrupt sitting time, suggesting potential health benefits. Additionally, a study involving older adults at risk of heart disease found that combining exercise with a technology-based intervention to reduce sitting time could improve health outcomes like blood pressure and waist circumference. These findings indicate that reducing sitting time and increasing physical activity can be an effective treatment for improving health. ^{1 2 3 4 5}

What safety data exists for the treatment of reducing sedentary behavior?

The provided research does not directly address safety data for the specific treatment of reducing sedentary behavior, such as the InPACT at Home study. However, it highlights the health risks associated with prolonged sitting and the potential benefits of interventions aimed at reducing sitting time. The studies emphasize the need for well-designed trials to test the efficacy and safety of such interventions, but specific safety data from these trials is not detailed in the abstracts provided. ^{3 5 6 7 8}

Is the treatment 'Interrupting Prolonged Sitting With ACTivity (InPACT) at Home' a promising treatment for a sedentary lifestyle?

Yes, the InPACT at Home treatment is promising because it focuses on reducing sitting time, which is important for health. Studies show that sitting too much can harm your heart and metabolism, even if you exercise regularly. By encouraging breaks from sitting, this treatment can help improve health and reduce risks associated with a sedentary lifestyle. ^{8 9 10 11 12}

Research Team

Rebecca E Hasson, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals who struggle with sticking to home exercise programs, possibly due to time constraints, low confidence in their abilities, or doubts about the program's effectiveness. It aims to help those who start exercising but stop when they see early results or think it's not necessary anymore. Children participating need parental support.

Inclusion Criteria

Participants must have access to a computer and internet at home

I am a child aged 8-12 from Michigan, or I am their parent/guardian.

Participants must be proficient in English

Exclusion Criteria

Potential participants who are ineligible will be informed during their screening call and will not be enrolled.

Children answering 'YES' to any question on the Physical Activity Readiness Questionnaire (PAR-Q)22 indicating heart condition, high BP, chest pains, dizziness during daily activities, or requiring a doctor's recommendation for supervision during exercise

My child has a disability that requires adult help for communication and following instructions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants engage in the InPACT at Home exercise program, completing three 8-minute exercise videos per day, five days a week.

4 weeks

Online engagement with exercise videos

Stage 2 Treatment

Participants continue with InPACT at Home, with some receiving additional support through text message reminders or personalized activity calendars.

4 weeks

Online engagement with exercise videos and additional support

Stage 3 Treatment

Participants receive further support through Tailoring or Coaching, based on previous assignments.

4 weeks

Online engagement with exercise videos and further support

Follow-up

Participants are monitored for adherence and effectiveness of the intervention.

1 week

Treatment Details

Interventions

• Interrupting Prolonged Sitting With ACTivity (InPACT) at Home Optimization Study

Trial Overview The study tests a new way of keeping people on track with their home exercises using a SMART intervention over 12 weeks. This method adapts the exercise plan based on how well someone is doing and tries to make sure that each person gets the right kind of encouragement and changes needed over time.

Participant Groups

Group I: Calendars + Tailored calendar Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars).

Group II: Calendars + Pings + Tailored Calendar Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars and text message pings).

Group III: Calendars + Pings + Pings Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars and text message pings).

Group IV: Calendars + Pings + Coaching Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars and text message pings) and virtually (coaching).

Group V: Calendars + Pings Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars and text message pings).

Group VI: Calendars Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars).

Group VII: Calendar + Tailored calendars + Pings Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars and text message pings).

Group VIII: Calendar + Tailored calendars + Coaching Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars) and virtually (coaching).

Group IX: Calendar + Tailored calendars Experimental Treatment 1 Intervention

Intervention is administered online (electronic calendars).

Interrupting Prolonged Sitting With ACTivity (InPACT) at Home Optimization Study is already approved in United States for the following indications:

Approved in United States as InPACT at Home for:

• Promoting physical activity in children and families

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

A pilot study involving 30 older adults (ages 50-70) showed that reducing daily sitting time by 2 hours was feasible and effective, while increasing sit-to-stand transitions did not change overall sitting time.

Participants in the sit-to-stand transition group successfully increased their transitions, indicating that specific behavioral goals can be targeted to reduce sedentary behavior in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults. Kerr, J., Takemoto, M., Bolling, K., et al.[2022]

This study aims to evaluate the effectiveness of combining structured exercise with a technology-based intervention to reduce sedentary behavior in older adults at risk for cardiovascular disease, addressing a significant public health concern.

By focusing on participants aged 60 and older with moderate to high risk of coronary heart disease, the research will assess various health outcomes, including daily activity patterns and cardiovascular function, to inform future large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable technology to reduce sedentary behavior and CVD risk in older adults: design of a randomized controlled trial. Krehbiel, LM., Layne, AS., Sandesara, B., et al.[2020]

A 1-week intervention using hourly prompts and behavioral strategies successfully reduced sitting time by an average of 1.85 hours per day in overweight/obese adults, while also increasing standing and stepping time.

Despite the reduction in sitting time, participants did not increase the frequency of sit/stand transitions, indicating a preference to remain standing longer rather than frequently interrupting sitting, which may inform future intervention designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot of an intervention to reduce and break-up overweight/obese adults' overall sitting-time. Júdice, PB., Hamilton, MT., Sardinha, LB., et al.[2018]

In a pilot study involving 10 sedentary, overweight or obese postmenopausal women, brief interruptions of sitting time (like standing for 2 minutes every 20 minutes or walking for 2 minutes every hour) showed potential benefits in lowering blood sugar responses after meals.

The 10-minute standing every hour condition significantly improved endothelial function, indicating vascular benefits compared to prolonged sitting, suggesting that different modalities of interrupting sitting can have specific health advantages for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute glucoregulatory and vascular outcomes of three strategies for interrupting prolonged sitting time in postmenopausal women: A pilot, laboratory-based, randomized, controlled, 4-condition, 4-period crossover trial. Kerr, J., Crist, K., Vital, DG., et al.[2020]

Sedentary behavior, especially prolonged sitting, is linked to increased risks of cardiovascular disease, highlighting the need for effective public health guidelines to reduce sitting time.

The review emphasizes the necessity for well-designed randomized controlled trials to test specific strategies for reducing sitting behavior, as current guidelines lack specificity due to insufficient evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Primer on Repeated Sitting Exposure and the Cardiovascular System: Considerations for Study Design, Analysis, Interpretation, and Translation. Stoner, L., Barone Gibbs, B., Meyer, ML., et al.[2023]

In a study of 727 adults, it was found that on average, people had 55 interruptions in their sitting time each day, but only about 20 of these were considered 'active' (involving at least 5 minutes of standing or 2 minutes of stepping).

Older adults, those with obesity, and individuals with diabetes had significantly fewer interruptions and less stepping time during active interruptions, suggesting that these groups may be less physically active in their daily routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive Epidemiology of Interruptions to Free-Living Sitting Time in Middle-Age and Older Adults. Blankenship, JM., Winkler, EAH., Healy, GN., et al.[2023]

Sedentary behavior, characterized by prolonged sitting, is linked to negative effects on cardiometabolic health and increased risk of premature mortality, highlighting the need for interventions to reduce sitting time.

Recent studies suggest that breaking up long periods of sitting can improve health outcomes, indicating that both primary prevention and disease management strategies should focus on reducing sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing sedentary behavior to reduce the risk of diabetes and cardiovascular disease. Dempsey, PC., Owen, N., Biddle, SJ., et al.[2022]

Sitting for long periods has harmful effects on cardiovascular and metabolic health, even for those who meet physical activity guidelines, highlighting the need to address sedentary behavior as a serious health risk.

Emerging evidence suggests that the physiological effects of inactivity are distinct from those of regular exercise, indicating that reducing sitting time and increasing breaks from sitting should be considered in health recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Too Little Exercise and Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on Sedentary Behavior. Hamilton, MT., Healy, GN., Dunstan, DW., et al.[2022]

Individuals with chronic health conditions, such as COPD and stroke, spent significantly more time being sedentary compared to healthy adults, with COPD patients averaging 62% of their waking hours sedentary.

The study found that the level of physiological impairment was a strong predictor of sedentary time, suggesting that targeted interventions could help reduce sedentary behavior in those with chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary Behavior in People with and without a Chronic Health Condition: How Much, What and When? Lewis, LK., Hunt, T., Williams, MT., et al.[2022]

The GIH stationary single-item question (SED-GIH) demonstrated good concurrent validity, showing a significant correlation with device-measured stationary time, making it a reliable tool for assessing sedentary behavior in the general population.

The SED-GIH also showed strong convergent validity with other commonly used sedentary questionnaires, indicating it can effectively identify individuals with high levels of stationary time, which is crucial for public health assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SED-GIH: A Single-Item Question for Assessment of Stationary Behavior-A Study of Concurrent and Convergent Validity. Kallings, LV., Olsson, SJG., Ekblom, Ö., et al.[2020]

Tailored counseling for office workers effectively reduced muscle inactivity time by an average of 33 minutes, leading to an increase in light muscle activity by 21 minutes, indicating a positive shift towards more active behavior.

The intervention also resulted in a 13% increase in average muscle activity during work, suggesting that even simple counseling can have significant short-term health benefits by encouraging movement and reducing sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle inactivity and activity patterns after sedentary time--targeted randomized controlled trial. Pesola, AJ., Laukkanen, A., Haakana, P., et al.[2022]

A review of 26 studies found that interventions aimed at reducing sedentary behavior in adults were categorized as very promising (39%), quite promising (21%), and non-promising (39%), with worksite-based interventions being the most common.

The most effective strategies included environmental restructuring and self-monitoring techniques, suggesting that future interventions should focus on modifying environments and enhancing self-regulatory skills to reduce sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. Gardner, B., Smith, L., Lorencatto, F., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Wearable technology to reduce sedentary behavior and CVD risk in older adults: design of a randomized controlled trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot of an intervention to reduce and break-up overweight/obese adults' overall sitting-time. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Acute glucoregulatory and vascular outcomes of three strategies for interrupting prolonged sitting time in postmenopausal women: A pilot, laboratory-based, randomized, controlled, 4-condition, 4-period crossover trial. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Primer on Repeated Sitting Exposure and the Cardiovascular System: Considerations for Study Design, Analysis, Interpretation, and Translation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Descriptive Epidemiology of Interruptions to Free-Living Sitting Time in Middle-Age and Older Adults. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Managing sedentary behavior to reduce the risk of diabetes and cardiovascular disease. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Too Little Exercise and Too Much Sitting: Inactivity Physiology and the Need for New Recommendations on Sedentary Behavior. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Sedentary Behavior in People with and without a Chronic Health Condition: How Much, What and When? [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The SED-GIH: A Single-Item Question for Assessment of Stationary Behavior-A Study of Concurrent and Convergent Validity. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Muscle inactivity and activity patterns after sedentary time--targeted randomized controlled trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. [2023]