Sedentary Reduction Strategies for Sedentary Lifestyle

(START Trial)

Not currently recruiting at 1 trial location

Overseen By Meredith Dobrosielski, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Diabetes, Alcohol/drug issues, Mobility, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways for older adults to reduce sitting time and increase activity. Researchers compare two methods: one replaces sitting with a single 30-minute walk each day, and the other involves three 10-minute walks spread throughout the day. The study aims to determine which method is easier to maintain and whether increased activity can improve mood, reduce stress and pain, and aid inflammation and metabolism. This trial suits older adults who feel fatigued, have low activity levels, or have experienced unintentional weight loss, and are willing to work up to walking 30 minutes a day.

As an unphased trial, this study offers participants a unique opportunity to contribute to understanding how simple lifestyle changes can enhance well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing physical activity rather than medication changes.

What prior data suggests that these sedentary reduction strategies are safe for older adults?

Research shows that sitting less can be safe and beneficial for older adults. Studies have found that programs designed to reduce sitting time are usually well-received. For instance, one study showed that participants reduced their sitting time by about 40 to 50 minutes each day without major issues.

These programs often lead to positive health outcomes. They can enhance overall health by lowering risks associated with excessive sitting, such as heart problems or high blood pressure. Evidence also indicates that sitting less can improve mood and energy levels.

Regarding safety, studies focused on reducing sitting time have reported no major negative effects. This suggests that these strategies are generally safe for most people, including those who may be frail. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these strategies for reducing sedentary lifestyles because they offer practical, everyday solutions to a common health issue. Unlike traditional advice, which often centers on general exercise recommendations, these interventions focus on breaking up sedentary time with manageable, light-intensity walking sessions. The bouted approach encourages three short, 10-minute walks throughout the day, while the continuous method suggests a single 30-minute walk. These strategies are easy to integrate into daily life, making them accessible for people who struggle with long periods of inactivity. The hope is that by nudging people to move more in small, consistent ways, these interventions could lead to significant improvements in overall health and well-being.

What evidence suggests that this trial's sedentary reduction strategies could be effective for reducing sedentary behavior?

Research shows that sitting less can improve health. This trial will compare two strategies for reducing sedentary time. Participants in one group will follow a structured intervention to replace sedentary time with three daily 10-minute light-intensity walking sessions. Studies have found that short active breaks like these can reduce sitting time by about 24 minutes each day, helping to lower blood pressure and improve overall well-being. Alternatively, participants in the other group will engage in one daily 30-minute light-intensity walking session. This method also reduces sitting time and can increase activity levels, potentially reducing stress and fatigue. ^{1 6 7 8 9}

Who Is on the Research Team?

Amal Wanigatunga, PhD

Principal Investigator

Johns Hopkins Blomberg School of Public Health

Are You a Good Fit for This Trial?

The START Trial is for adults aged 65 or older who are at risk of becoming frail but can still walk. They should be somewhat inactive, doing less than 20 minutes of physical activity per day, and willing to increase their walking time. People with severe health issues like uncontrolled high blood pressure, cognitive impairment, or those needing help to walk aren't eligible.

Inclusion Criteria

I am somewhat frail, experiencing minor weight loss, fatigue, or low activity.

I am 65 years old or older.

Exclusion Criteria

Participation in another clinical trial

Plan to move out of the area within 6 months

I cannot drive myself to study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized into one of two sedentary reduction behavior programs to replace sedentary time with walking over 60 days

8 weeks

Remote monitoring

Follow-up

Participants are monitored for changes in sedentary behavior, physical activity, and health outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bouted sedentary reduction intervention
• Continuous sedentary reduction intervention

Trial Overview This trial tests two programs designed to reduce sitting time in seniors: one replaces it with a single daily 30-minute walk; the other splits this into three shorter walks throughout the day. The study will see which method is better over a period of 60 days for improving activity levels and overall well-being.

How Is the Trial Designed?

Group I: Continuous sedentary reduction intervention Active Control 1 Intervention

Structured intervention to progressively replace sedentary time with one daily 30-minute light-intensity walking bout

Group II: Bouted sedentary reduction intervention Active Control 1 Intervention

Structured intervention to progressively replace sedentary time with three daily 10-minute light-intensity walking bouts

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

This systematic review aims to evaluate process evaluations of randomized controlled trials (RCTs) that measure sedentary behavior in adults, focusing on understanding effective intervention strategies and participant experiences.

The review will exclude interventions delivered in schools, colleges, or workplaces, and will contribute to developing a community-based intervention specifically aimed at reducing sedentary behavior in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protocol for a systematic review of process evaluations of interventions investigating sedentary behaviour in adults. Corepal, R., Hall, JF., English, C., et al.[2021]

The workshop emphasized the need for standardized, objective measures of physical activity and sedentary behavior in cohort studies to improve the quality and comparability of research findings.

It recommended creating a network of connected studies and health systems to enhance research efficiency and access to data, while also focusing on high-risk populations and comparative effectiveness designs to better translate findings into practical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel strategies for sedentary behavior research. Rosenberg, DE., Lee, IM., Young, DR., et al.[2022]

The Core Research Outcomes for Sedentary Behaviour Interventions (CROSBI) study established a standardized core outcome set (COS v1.0) consisting of 53 data items across 12 domains to improve the consistency of reporting in sedentary behavior research.

The consensus emphasizes the importance of using devices that measure posture and sedentary behavior accurately, which will help enhance the quality and comparability of future intervention studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Standardised Core Outcome Set for Measurement and Reporting Sedentary Behaviour Interventional Research: The CROSBI Consensus Study. Curran, F., Dowd, KP., Peiris, CL., et al.[2022]

Interventions that use self-monitoring techniques significantly reduce total sedentary time in adults, with a moderate effect size (Hedges g = 0.32) based on a systematic review of 19 studies involving 2800 participants.

The most effective self-monitoring interventions were those that utilized objective tools and specifically targeted sedentary behavior, indicating that the method of monitoring plays a crucial role in achieving behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions using self-monitoring to reduce sedentary behavior in adults: a systematic review and meta-analysis. Compernolle, S., DeSmet, A., Poppe, L., et al.[2020]

A systematic review of 18 randomized clinical trials involving 2298 sedentary individuals found that digital behavior change interventions (DBCIs) effectively improve physical activity and reduce sedentary behavior, with follow-up durations ranging from 5 weeks to 3 years.

The most frequently employed behavior change techniques (BCTs) in these interventions included goal setting, self-monitoring, and social support, indicating that structured planning and feedback are key components for success in modifying sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior Change Techniques and the Effects Associated With Digital Behavior Change Interventions in Sedentary Behavior in the Clinical Population: A Systematic Review. Martín-Martín, J., Roldán-Jiménez, C., De-Torres, I., et al.[2021]

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]

A systematic review of 7 randomized controlled trials found that interventions specifically targeting sedentary behavior can reduce daily sitting time by an average of 32.4 minutes, while increasing standing time by 31.75 minutes and stepping time by 9.5 minutes.

Effective interventions often included behavior change techniques such as 'feedback on behavior' and 'goal setting', indicating that these strategies are crucial for successfully reducing sedentary behavior in healthy adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, characteristics, behavioural models and behaviour change strategies, of non-workplace interventions specifically targeting sedentary behaviour; a systematic review and meta-analysis of randomised control trials in healthy ambulatory adults. Curran, F., Blake, C., Cunningham, C., et al.[2021]

A systematic review of nine studies involving 394 cancer patients or survivors found that interventions aimed at reducing sedentary behaviors (SB) showed promise, with participants often reducing SB and increasing moderate-to-vigorous physical activity.

Most studies focused on feasibility and utilized wearable devices to encourage behavior change, but there is a need for more high-quality randomized controlled trials to better understand effective strategies for reducing SB in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Reduce Sedentary Behavior in Cancer Patients and Survivors: a Systematic Review. Belcher, BR., Kang, DW., Yunker, AG., et al.[2023]

This systematic review aims to evaluate the effectiveness of interventions designed to reduce sedentary behavior in older adults (aged 60 and above) living in long-term care facilities, where sedentary behavior is particularly prevalent, averaging 9.4 hours per day.

The review will follow rigorous methods, including the PRISMA guidelines and risk of bias assessments, to ensure reliable results that could inform future interventions aimed at improving health outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Interventions for Reducing Sedentary Behaviour in Older Adults Living in Long-Term Care Facilities: A Protocol for a Systematic Review. Karkauskiene, E., Tully, MA., Dudoniene, V., et al.[2023]

Older adults often lack awareness and knowledge about sedentary behavior, which can hinder efforts to reduce it, as highlighted in a systematic review of 15 qualitative studies.

Sedentary behavior is deeply ingrained in the daily routines of older adults and is often associated with positive feelings, making it challenging to change; this suggests that interventions need to be enjoyable and convenient to be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults' Perceptions of Sedentary Behavior: A Systematic Review and Thematic Synthesis of Qualitative Studies. Compernolle, S., De Cocker, K., Cardon, G., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03307343

Effect of Reducing Sedentary Behavior on Blood Pressure This is a 2-arm, 3-month randomized trial comparing a novel sedentary behavior intervention vs. control in working adults (n=271). The primary outcome is ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10379966/

Effectiveness of Interventions for Reducing Sedentary ... Effectiveness of interventions for reducing sedentary behaviour in older adults living in long-term care facilities: a protocol for a systematic review.

3. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-023-01419-z

main outcomes of the SIT LESS randomised clinical trial This clinical trial investigated the effectiveness of a sedentary behaviour intervention as a personalised secondary prevention strategy (SIT LESS) on changes ...

4. withpower.com withpower.com/trial/phase-frailty-9-2023-536c6

Sedentary Reduction Strategies for ... The goal of this behavioral clinical trial is to compare two different ways of becoming less sedentary and more active in 60 older adults at elevated risk ...

5. sjweh.fi sjweh.fi/show_abstract.php?abstract_id=4224&fullText=1

Effectiveness of short active breaks for reducing sedentary ... Results At the one-year follow-up assessment, sedentary behaviors during working hours in the intervention group decreased by 24.4 minutes (95% ...

6. clinicaltrials.gov clinicaltrials.gov/show/NCT03307343

Effect of Reducing Sedentary Behavior on Blood Pressure The primary outcome is resting systolic blood pressure (SBP) at 3 months; secondary outcomes will be resting diastolic blood pressure (DBP), ambulatory blood ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4362870/

Interventions to Reduce Sedentary Behavior - PMC This paper reports on presentations and discussion from the working group on “Influences on Sedentary Behavior & Interventions”

8. sedentarybehaviour.org sedentarybehaviour.org/sedentary-research-database/

Sedentary Research Database - The ... High volumes of sedentary behavior may increase the risk of future hospitalization. Our results support the public health message "sit less and move more".

9. bjsm.bmj.com bjsm.bmj.com/content/55/3/144

Effects of sedentary behaviour interventions on biomarkers ... Our review of interventions targeting sedentary behaviour reductions alone, or combined with increases in physical activity, found evidence of effectiveness.