Sedentary Reduction Strategies for Sedentary Lifestyle

(START Trial)

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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for reducing sedentary behavior?

Research shows that interventions specifically targeting sedentary behavior, such as those involving self-monitoring and environmental changes, are promising in reducing sitting time. These strategies have been effective in various settings, including among cancer patients and older adults, suggesting they could be beneficial for sedentary lifestyle interventions. ^{1 2 3 4 5}

Is the sedentary reduction intervention safe for humans?

The research does not provide specific safety data for sedentary reduction interventions, but these interventions generally focus on reducing sitting time, which is unlikely to pose significant safety risks for healthy individuals. ^{2 3 4 6 7}

How is the sedentary reduction treatment different from other treatments for a sedentary lifestyle?

This treatment is unique because it specifically targets reducing sedentary behavior as its main goal, rather than focusing on increasing physical activity. It uses strategies like self-monitoring and environmental changes to help people become more aware of and reduce their sitting time. ^{4 5 8 9 10}

What is the purpose of this trial?

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 of becoming frail. The main question this project aims to answer are whether participants in each intervention are able to gradually replace 30 minutes of sedentary (sitting-like) behavior with very light walking over 60 days. There are other questions this project aims to answer that include: 1. whether it is easier to replace sedentary behavior with one 30-minute walking bout or three 10-minute walking bouts 2. whether becoming less sedentary and more active leads to feeling better, have less stress, pain, and fatigue and have more confidence in becoming more regularly active 3. whether becoming less sedentary and more active leads to better regulation of inflammation and metabolism Participants will be randomized into one of two sedentary reduction behavior programs; one program that gradually replaces sedentary time with one 30-minute walking bout and the other program that gradually replaces sedentary time with three 10-minute walking bouts in the morning, afternoon, and evening. Researchers will compare both programs to see which one is easier to achieve and maintain over 60 days.

Research Team

Amal Wanigatunga, PhD

Principal Investigator

Johns Hopkins Blomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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]

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]

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]

References

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

Interventions to Reduce Sedentary Behavior in Cancer Patients and Survivors: a Systematic Review. [2023]

2. Switzerland 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. [2023]

3. Switzerland 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. [2021]

4. United States 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. [2021]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

A protocol for a systematic review of process evaluations of interventions investigating sedentary behaviour in adults. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Standardised Core Outcome Set for Measurement and Reporting Sedentary Behaviour Interventional Research: The CROSBI Consensus Study. [2022]

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

Novel strategies for sedentary behavior research. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions using self-monitoring to reduce sedentary behavior in adults: a systematic review and meta-analysis. [2020]

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

Older Adults' Perceptions of Sedentary Behavior: A Systematic Review and Thematic Synthesis of Qualitative Studies. [2021]