Behavior Change Techniques for Physical Inactivity

Overseen By Ashley Goodwin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Unsafe walking, No smartphone, No email, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized text-message program, part of the Behavior Change Technique Package, can help caregivers of individuals with Alzheimer's or related dementias develop a walking habit. The program encourages participants to walk at least 1,000 steps in a one-hour period each day for a week, using daily messages for goal setting and self-monitoring. Caregivers who struggle with physical activity and can commit to regular walking might find this trial suitable. As an unphased trial, it offers caregivers a unique opportunity to enhance their health through innovative support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavior change technique is safe?

Research shows that behavior change techniques (BCTs) are generally safe for participants. These techniques promote healthy habits, such as increasing exercise. Studies have found that BCTs can encourage people to sit less without causing harm.

In this trial, personalized text messages will help participants build a walking habit. This method is non-invasive, as it doesn't involve medical procedures or medications. Instead, it uses strategies like setting goals and tracking progress to motivate change. Previous studies have not reported any negative effects from similar methods. Therefore, the researchers expect the techniques used in this trial to be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavior Change Technique Package because it offers a personalized, habit-focused approach to tackling physical inactivity. While traditional options often include exercise programs or general guidelines, this treatment provides a daily, tailored combination of four techniques: Goal Setting, Action Planning, Self-Monitoring, and Prompt/Cue. These elements are designed to integrate into daily life, fostering long-term physical activity habits based on habit formation theory. By focusing on personal behavior change, this approach could lead to more sustainable lifestyle improvements compared to standard exercise recommendations.

What evidence suggests that this behavior change technique is effective for increasing physical activity?

Research has shown that strategies like setting goals, making action plans, tracking progress, and using reminders can help people become more active. Studies have found these methods effective in forming habits, such as walking more each day and sitting less. For instance, a review found that digital tools using these strategies successfully increased activity levels in less active adults. Another study showed that combining these strategies often leads to better results in encouraging regular exercise. These techniques work by gradually integrating physical activity into daily life. Participants in this trial will receive a 12-week, single-arm, multi-component, personalized Behavior Change Technique (BCT) intervention, incorporating these strategies to support habit formation and increased physical activity. ^{6 7 8 9 10}

Who Is on the Research Team?

Mark Butler, PhD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for caregivers of individuals with Alzheimer's Disease or related disorders who are not regularly active. They must be willing to follow a personalized walking plan aiming for habitual physical activity, specifically walking.

Inclusion Criteria

Self-report low levels of physical activity or walking

I primarily speak English or Spanish.

Identify as a caregiver (formal/paid or informal/unpaid) for persons with Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD)

Exclusion Criteria

Lives outside the United States

Does not own or cannot regularly access a smartphone capable of receiving text messages or accessing the internet

My doctor says it's unsafe for me to participate in walking activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 12-week, multi-component, personalized BCT intervention to encourage habitual physical activity

12 weeks

Daily text-message interventions

Follow-up

Participants are monitored for habit formation and changes in automaticity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavior Change Technique Package

Trial Overview The study tests a behavior change technique delivered through personalized text messages over 12 weeks. It aims to establish regular walking habits (1,000 steps during an hour on consecutive days) in participants.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This will be a 12-week, single-arm, multi-component, personalized BCT intervention. We will provide participants with 4 BCTs daily (Goal Setting, Action Planning, Self-Monitoring, and Prompt/Cue) that have been associated with habit formation theory and development of physical activity habits in prior research.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8521816/

Behavior Change Techniques and the Effects Associated ... This study aimed to do a systematic review of the evidence concerning the most frequently used BCTs in digital health and the effect associated with DBCIs for ...

2. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-020-01001-x

Which behaviour change techniques are effective to promote ... This study provides indications that different (combinations of) BCTs may be effective to promote PA and reduce SB.

3. academic.oup.com academic.oup.com/tbm/article/9/1/147/4913688

Are physical activity interventions for healthy inactive adults ... This review showed that interventions aiming to increase physical activity in healthy inactive adults are effective in promoting behavior change and behavior ...

4. mhealth.jmir.org mhealth.jmir.org/2022/5/e35920/

mHealth Interventions to Reduce Physical Inactivity and ... This review and meta-analysis investigated the effectiveness of mHealth interventions on IPA and SB, with a special focus on the age and level of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405457722002893

Sedentary behavior, physical inactivity, abdominal obesity ... We found elevated rates of sedentary behavior and physical inactivity in individuals with obesity and a positive risk association.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6194316/

Tackling Youth Inactivity and Sedentary Behavior in an ... Primary outcomes were physical activity and sedentary behavior. Secondary outcome was BMI z-score. Physical activity did not change (0; 95%CI:-2.7–2.8 min/day; ...

7. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-020-00957-0

The effectiveness and complexity of interventions targeting ... Accumulating evidence suggests that SB is associated with poor health outcomes [3, 4]. These relationships appear to remain after statistical ...

8. mdpi.com mdpi.com/2076-328X/14/12/1224

A Systematic Review with Meta-Analyses This systematic review and meta-analysis demonstrated the effectiveness of physical activity interventions and highlighted effective and negative components.

9. bmjopensem.bmj.com bmjopensem.bmj.com/content/7/1/e000960

Changes in physical activity and sedentary behaviours ... The coprimary outcomes were changes in physical activity and/or sedentary behaviour captured via device-based measures or self-report tools.

10. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012784.pub2/full

Interventions for reducing sedentary behaviour in ... The evidence suggests that interventions to change sedentary behaviour in community‐dwelling older adults may reduce sedentary time.