Step Counts for Obesity

Overseen By Brian Kliszczewicz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kennesaw State University

Must be taking: Hypertension, Osteoarthritis

Must not be taking: Glucose regulators, Metabolism affectors

Disqualifiers: Cardiovascular, Metabolic, Renal, Pulmonary, others

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

Compensation: Varies

Number of Visits: 5

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how daily step counts can help individuals who are overweight or obese achieve weight loss and improve heart health. Participants will track their steps with a pedometer over eight months, aiming for step goals tailored to their body weight and composition. The researchers aim to develop a model for prescribing physical activity more effectively for weight management. Suitable candidates include those who are otherwise healthy, have a stable weight, and do not regularly engage in structured exercise like jogging or cycling. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to more effective weight management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medication to regulate blood sugar or affect metabolism, you cannot participate.

What prior data suggests that this method is safe for weight management?

Research shows that tracking daily steps can safely and effectively manage weight and improve health. Studies have found that individuals who monitor their steps and aim for daily targets, often around 10,000 steps, tend to lose weight and reduce health risks. For instance, one study found that using devices to track steps led to noticeable weight loss and improvements in body mass index (BMI), a measure of body fat based on height and weight.

Another study suggested that taking more steps each day is linked to a lower risk of death from any cause and fewer heart-related issues. These findings indicate that increasing daily steps is generally safe and doesn't cause serious side effects.

Overall, using step counts to encourage physical activity appears to be a safe method for most people seeking to manage weight and improve health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of using step count targets as a tool for weight loss and improving heart health in a predictable way. Unlike conventional treatments for obesity, which often involve medications or surgical options, this approach focuses on a natural lifestyle change by encouraging regular physical activity. By setting a specific step count goal, participants may achieve a 5% reduction in body weight, which can significantly improve their overall health. This method not only promotes physical activity but also empowers individuals to take charge of their health in an accessible and non-invasive manner.

What evidence suggests that step counts are effective for obesity?

Research shows that tracking steps and aiming for a daily target can aid in weight loss and health improvement. In this trial, participants will follow a regimen of regular step count targets to achieve predictable weight loss. Studies have found that using devices to count steps can result in noticeable weight loss and reduced body fat. One study discovered that increasing daily steps could halve the risk of obesity over five years. Another review found that these step-count goals can increase activity levels. This evidence suggests that setting step goals can lead to expected improvements in weight and health. ^{5 6 7 8 9}

Who Is on the Research Team?

Robert Buresh, PhD

Principal Investigator

Kennesaw State University

Are You a Good Fit for This Trial?

This trial is for overweight or obese adults of various age groups who are experiencing conditions like hypertension, chronic inflammation, diabetic dyslipidemia, metabolic syndrome, type 2 diabetes, high cholesterol, and high blood pressure. The study aims to include a diverse range of participants from young to elderly (20-80+ years old).

Inclusion Criteria

I am 20 years old or older.

Sedentary people, or people who report engaging in regular walking (no regular structured exercise for at least the past six months)

Relatively stable weight over the previous 6 months (less than 5% fluctuation in body weight)

Exclusion Criteria

Current smokers

People who have engaged in a program of structured exercise other than walking (e.g., weight training, jogging, swimming, cycling) within the last six months

I have a diagnosed heart, lung, kidney disease, or cognitive issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Baseline Assessment

Initial assessment of body composition, cardiometabolic risk factors, and step count prescription

1 day

1 visit (in-person)

Phase One: Step Count Monitoring

Participants carry pedometers to record daily step counts and undergo body composition and CMR assessment

4 weeks

2 visits (in-person)

Phase Two: Step Count Intervention

Participants follow step count targets for weight loss and body composition improvement

8 months

Regular check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in body composition and cardiometabolic risk factors after intervention

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Step counts for predictable changes in body weight/composition and cardiometabolic risk

Trial Overview The trial is testing if prescribing daily step counts based on body weight/composition can predictably change body composition and reduce cardiometabolic risk factors in adults. Participants will follow targeted step count goals over eight months while eating normally.

How Is the Trial Designed?

Group I: Regular accumulation of step count targets to achieve predictable weight loss Experimental Treatment 1 Intervention

Participants will be provided a step count goal that may be expected to result in a weight loss of 5% of body weight, and will carry a pedometer for 8 months while striving to consistently reach the step count target.

Who Is Running the Clinical Trial?

Kennesaw State University

Lead Sponsor

Trials

14

Recruited

860+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07221279

Prescription of Step Counts for Targeted Changes in Body ... Participants will be provided a step count goal that may be expected to result in a weight loss of 5% of body weight, and will carry a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11325471/

Effectiveness of utilizing step-monitoring devices to prevent ... Our results showed that step-monitoring device-based interventions led to statistically significant reductions in BMI-Z (–0.06) and body weight ...

3. nature.com nature.com/articles/s41591-022-02012-w

Association of step counts over time with the risk of chronic ... This increase in step counts resulted in a 50% reduction in cumulative incidence of obesity at 5 years from 16% (95% CI 11, 20) at the 25th ...

4. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-020-01020-8

The effects of step-count monitoring interventions on physical ... This review demonstrated that step-count monitoring interventions can lead to sustained increases in people's walking, but that fitness trackers ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076251374249

Effectiveness of step-count monitoring interventions in ... Step-count monitoring interventions may be appropriate and effective for increasing total physical activity and reducing SB in children and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5970037/

Pattern of Daily Steps is Associated with Weight Loss The results show that those individuals achieving ≥10% weight loss at 18 months were engaging in approximately 10,000 total steps·day−1, which ...

7. medrxiv.org medrxiv.org/content/10.1101/2024.10.23.24315952v2.full-text

Step Counts and Physical Activity Trends: A 3-Month ... This study examined daily step count data using wearable devices and fitness Applications to assess activity patterns, consistency, and goal ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/14/10/e088524

Objectively measured daily steps and health outcomes The results of this study suggest that daily steps are associated with a lower risk of all-cause mortality and cardiovascular events.

9. healthyfood.com healthyfood.com/advice/tracking-daily-step-counts-can-be-a-useful-tool-for-weight-management-an-exercise-scientist-parses-the-science/

Tracking daily step counts can be a useful tool for weight ... We have used our data to develop a model that predicts average daily step counts per unit of fat mass from body fat percentage. We believe that this model can ...