Behavioral Intervention for Increasing Walking in Cardiovascular Disease Risk

Overseen By Karina Davidson, PhD, MASc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwell Health

Disqualifiers: Heart attack, Stroke, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

624 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized, factorial experiment using the basic Science of Behavior Change (SOBC) approach to efficiently test the effects of four distinct behavior change techniques (BCTs), goal setting, action planning, self- monitoring and feedback, thought to engage one key behavioral mechanism of action (MoA) for improving daily walking by at least 1000 steps per day in persons who have been objectively verified as sedentary and are at risk for cardiovascular disease.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Action Planning, Behavioral Intervention for Walking, and Feedback on Behavior for increasing walking in people at risk of cardiovascular disease?

Research shows that frequent prompting, such as regular phone calls, can significantly increase exercise adherence, with 46% of participants meeting walking goals compared to 13% with less frequent prompts. Additionally, reinforcement interventions, like offering prizes, helped older adults meet walking goals on 82.5% of days, suggesting that these strategies can effectively promote walking. ^{1 2 3 4 5}

Is the behavioral intervention for increasing walking safe for humans?

The research does not report any safety concerns for the behavioral interventions aimed at increasing walking, suggesting they are generally safe for humans. ^{2 3 6 7 8}

How is the behavioral intervention for increasing walking in cardiovascular disease risk different from other treatments?

This treatment is unique because it combines several behavioral strategies like action planning, feedback, and goal setting to specifically increase walking in people at risk for cardiovascular disease. Unlike other treatments that may focus on general physical activity, this intervention is tailored to enhance walking through structured behavioral techniques. ^{2 3 6 7 9}

Research Team

Karina W Davidson, PhD, MASc

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for adults aged 18-74 who are sedentary, generally healthy, at risk for cardiovascular disease (CVD), and have not been advised against low-intensity walking. Participants must own a smartphone and email account. Excluded are those with poor health, mobility issues, serious heart conditions, cognitive impairments or major mental health diagnoses.

Inclusion Criteria

Report they are in good general health and have never been informed by a clinician that it was not advisable/safe to participate in a low-intensity walking program

I am between 18 and 74 years old.

I am mostly inactive in my daily life.

Exclusion Criteria

Pregnancy

Inability to comply with study protocol during 4 week baseline period

I have had a heart attack, stroke, peripheral vascular disease, or received a stent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Continuous monitoring via Fitbit and survey completion

Intervention

Participants receive daily text messages with behavior change techniques to increase daily walking by 1,000 steps

8 weeks

Daily virtual engagement via text messages

Follow-up

Participants are monitored for changes in physical activity and self-efficacy after the intervention

12 weeks

Continuous monitoring via Fitbit and bi-weekly surveys

Treatment Details

Interventions

• Action Planning
• Feedback on Behavior
• Goal Setting
• MoST-Influenced Behavioral Intervention for Walking
• Self-Monitoring of Behavior

Trial Overview The study tests four behavior change techniques: goal setting, action planning, self-monitoring of behavior, and feedback on behavior to increase daily walking by at least 1000 steps in sedentary individuals at risk for CVD. It's a randomized experiment that assigns participants to different combinations of these techniques.

Participant Groups

Group I: Self-Monitoring and Feedback Experimental Treatment 2 Interventions

Participants in this arm will receive daily text messages that include the Self-Monitoring and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group II: Self-Monitoring Experimental Treatment 1 Intervention

Participants in this arm will receive daily text messages with the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group III: Goal Setting and Self-Monitoring and Feedback Experimental Treatment 3 Interventions

Participants in this arm will receive daily text messages that include the Goal Setting, Self-Monitoring, and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group IV: Goal Setting and Self-Monitoring Experimental Treatment 2 Interventions

Participants in this arm will receive daily text messages that include the Goal Setting and Self-Monitoring behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group V: Goal Setting and Feedback Experimental Treatment 2 Interventions

Participants in this arm will receive daily text messages that include the Goal Setting and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group VI: Goal Setting and Action Planning, and Self-Monitoring Experimental Treatment 3 Interventions

Participants in this arm will receive daily text messages that include the Goal Setting, Action Planning, and Self-Monitoring behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group VII: Goal Setting and Action Planning and Self-Monitoring and Feedback Experimental Treatment 4 Interventions

Participants in this arm will receive daily text messages that include the Goal Setting, Action Planning, Self-Monitoring, and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group VIII: Goal Setting and Action Planning and Feedback Experimental Treatment 3 Interventions

Participants in this arm will receive daily text messages that include the Goal Setting, Action Planning, and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group IX: Goal Setting and Action Planning Experimental Treatment 2 Interventions

Participants in this arm will receive daily text messages that include the Goal Setting and Action Planning behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group X: Goal Setting Experimental Treatment 1 Intervention

Participants in this arm will receive daily text messages with the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group XI: Feedback Experimental Treatment 1 Intervention

Participants in this arm will receive daily text messages with the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group XII: Action Planning and Self-Monitoring, and Feedback Experimental Treatment 3 Interventions

Participants in this arm will receive daily text messages that include the Action Planning, Self-Monitoring, and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group XIII: Action Planning and Self-Monitoring Experimental Treatment 2 Interventions

Participants in this arm will receive daily text messages that include the Action Planning and Self-Monitoring behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group XIV: Action Planning and Feedback Experimental Treatment 2 Interventions

Participants in this arm will receive daily text messages that include the Action Planning and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group XV: Action Planning Experimental Treatment 1 Intervention

Participants in this arm will receive daily text messages with the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.

Group XVI: Control Active Control 1 Intervention

Participants in this arm will not receive any daily BCT text messages. Instead, individuals receive daily text messages with the text "Please acknowledge that you have received this text message."

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study of 135 participants in a walking program, those who received weekly phone prompts were significantly more likely to meet exercise goals (46%) compared to those prompted every three weeks (13%).

The structure of the prompts (high vs. low) did not show a significant difference in effectiveness, indicating that the frequency of reminders is more crucial for improving exercise adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking to meet health guidelines: the effect of prompting frequency and prompt structure. Lombard, DN., Lombard, TN., Winett, RA.[2019]

A 12-week reinforcement intervention using pedometers and monetary incentives significantly increased walking among 45 sedentary older adults with hypertension, with participants walking an average of 2,000 more steps per day compared to a control group.

The reinforcement group not only met their walking goals on 82.5% of days but also experienced greater reductions in blood pressure and weight, indicating that such interventions could effectively promote healthier lifestyles in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized study of reinforcing ambulatory exercise in older adults. Petry, NM., Andrade, LF., Barry, D., et al.[2022]

A study involving 125 sedentary ethnic minority women showed that both a behavioral intervention and a brief educational intervention significantly increased walking time over 2 months, with participants walking an average of 86 and 81 minutes more per week, respectively.

At a 30-month follow-up, both groups continued to report increased walking compared to their baseline levels, but the behavioral intervention did not prove to be more effective than the educational condition, suggesting that simpler strategies may be sufficient for promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home-based behavioral intervention to promote walking in sedentary ethnic minority women: project WALK. Chen, AH., Sallis, JF., Castro, CM., et al.[2021]

A study involving 248 initially sedentary women identified two distinct groups based on their response to a walking intervention: responders and nonresponders, highlighting the variability in how individuals react to the same program.

The research suggests that interventions should be personalized, taking into account each woman's physical, psychosocial, and environmental factors, as well as their specific goals for physical activity and mood improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responders and nonresponders to a walking intervention for sedentary women. Nies, MA., Sun, Y.[2016]

A systematic review of 52 studies identified 46 behavior change techniques (BCTs) linked to 21 mechanisms of action (MoAs) that enhance physical activity and dietary behavior in adults with chronic conditions.

Key long-term facilitators for effective planning interventions included self-monitoring, problem-solving, and providing instructions, with successful interventions showing higher scores in intention and behavioral regulation according to the Health Action Process Approach (HAPA) model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour change techniques that constitute effective planning interventions to improve physical activity and diet behaviour for people with chronic conditions: a systematic review. Lin, H., Xu, D., Yang, M., et al.[2022]

A six-month internet-based walking program using web-enhanced pedometers led to significantly greater weight loss (-1.9 kg) in 255 male Veterans at risk for cardiovascular disease compared to time-based (-0.7 kg) and simple pedometer-based walking goals (-0.6 kg).

The study involved participants with a mean age of 56.3 years and a BMI of 36.3, showing that technology-enhanced self-monitoring can effectively improve adherence and outcomes in walking programs for individuals with cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Effectiveness Trial of Three Walking Self-monitoring Strategies. Richardson, CR., Goodrich, DE., Larkin, AR., et al.[2020]

The WalkIT Trial is a 4-month randomized controlled trial designed to evaluate whether adaptive components in walking interventions can lead to greater increases in physical activity among inactive, overweight, or obese adults compared to static components.

Using a factorial design, the study aims to understand the effectiveness of different goal-setting and reward strategies delivered via text messages, which could inform future health promotion efforts and mobile health (mHealth) initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults. Hurley, JC., Hollingshead, KE., Todd, M., et al.[2020]

A review of 984 articles identified 304 relevant studies on technology-enabled interventions for cardiovascular disease (CVD) prevention, highlighting the importance of using health behavior change techniques like self-monitoring and feedback, which were the most common techniques employed.

Over half of the intervention studies utilized established health behavior theories, with Social Cognitive Theory being the most frequently cited, suggesting that integrating these theories with various evidence-based techniques can enhance the effectiveness of CVD interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Behavior Change Techniques and Theory in Technologies for Cardiovascular Disease Prevention and Treatment in Adults: A Comprehensive Review. Winter, SJ., Sheats, JL., King, AC.[2022]

Both self-help print materials and telephone-assisted counseling effectively increased the amount of time participants walked for exercise, with significant improvements in both intervention groups (399 participants total).

The addition of telephone support helped participants engage more with the print materials, but it did not lead to a greater increase in walking compared to the print-only program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of print and telephone delivered interventions to influence walking. Humpel, N., Marshall, AL., Iverson, D., et al.[2015]

References

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

Walking to meet health guidelines: the effect of prompting frequency and prompt structure. [2019]

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

A randomized study of reinforcing ambulatory exercise in older adults. [2022]

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

A home-based behavioral intervention to promote walking in sedentary ethnic minority women: project WALK. [2021]

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

Responders and nonresponders to a walking intervention for sedentary women. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Behaviour change techniques that constitute effective planning interventions to improve physical activity and diet behaviour for people with chronic conditions: a systematic review. [2022]

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

A Comparative Effectiveness Trial of Three Walking Self-monitoring Strategies. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults. [2020]

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

The Use of Behavior Change Techniques and Theory in Technologies for Cardiovascular Disease Prevention and Treatment in Adults: A Comprehensive Review. [2022]

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

Trial of print and telephone delivered interventions to influence walking. [2015]