Lifestyle Promotion Intervention for Obesity

(CIRCUIT Trial)

Overseen By Melanie Henderson, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Physical, psychological conditions, 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?

The trial aims to promote physical activity and reduce sedentary time in children and adolescents with health risks such as obesity, high blood pressure, or blood sugar issues. Wearable sensors gather data on movement and activity to help tailor a personalized plan. Participants join either a group using this sensor-based physical activity intervention or receive traditional physical activity counseling. Children aged 6 to 18 with a BMI above the 95th percentile (indicating obesity) may be suitable if they have no conditions preventing physical activity. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve health outcomes for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this lifestyle intervention is safe for children and adolescents?

Research has shown that using wearable sensors to track physical activity in children is generally safe. In past studies, children who used these devices experienced positive outcomes. For instance, one study found that participants had a lower body mass index (BMI) and increased activity levels, suggesting that the devices were well-received.

Another study examined safety and found no major problems linked to wearable technology. These sensors collect data like heart rate and movement, which helps create personalized activity plans. The technology has been used in similar programs without major safety concerns.

Overall, using wearable sensors in these programs appears safe and is well-liked by participants, making it a promising way to encourage physical activity in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Promotion Intervention for Obesity because it leverages technology to create a personalized approach to increasing physical activity. The sensor-based intervention equips children with devices like heart rate monitors and GPS trackers to gather real-time data, which is then used to develop a tailored activity plan based on their everyday environment. This data-driven, customized approach offers a fresh perspective compared to traditional physical activity counseling, which does not utilize sensor data for personalization. By integrating technology to provide a spatio-behavioral diagnosis, this method holds the promise of more effectively promoting physical activity among children.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that wearable sensors can help manage obesity and improve lifestyle habits. In this trial, one group of participants will receive the Sensor-based Physical Activity (PA) intervention, which uses these sensors to track activity and develop personalized lifestyle plans. Studies have found that such sensor-based interventions can lead to weight loss, a smaller waist size, and a noticeable drop in BMI (a measure of body fat based on height and weight), while also increasing daily activity levels. By personalizing lifestyle plans with these devices, participants can stay more committed and see better results. This evidence suggests that using sensors to monitor activity and provide tailored advice might help reduce obesity-related risks in children and teens. Meanwhile, another group in this trial will receive Traditional PA counseling, which does not rely on sensor data for intervention. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

The Dynamo trial is for children and teens aged 6 to 17 with obesity, specifically those with a BMI over the 95th percentile for their age and sex. It's not suitable for kids who have physical or mental health issues that would limit their ability to be active.

Exclusion Criteria

My child cannot participate in physical activities due to a condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Participants undergo the Dyn@mo lifestyle intervention, which includes wearing sensors to gather data on mobility and physical activity for a tailored plan

1 year

Initial setup and periodic follow-ups

Follow-up

Participants are monitored for changes in cardiometabolic risk factors such as blood pressure, lipid status, BMI, and glucose homeostasis

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Sensor based PA intervention
• Traditional PA counseling

Trial Overview

This study tests a lifestyle program aimed at increasing physical activity and reducing sitting time in young people with obesity-related health risks. Participants will either get standard advice on being active or use wearable sensors that help tailor this advice.

How Is the Trial Designed?

Group I: Traditional PA counseling Experimental Treatment 1 Intervention

In this arm, while children will wear the same sensors as in the intervention arm, the intervention will not rely on data gathered using the wearable sensors. Rather, a traditional physical activity counseling strategy will be adopted in this control group.

Group II: Sensor based PA intervention Experimental Treatment 1 Intervention

Children will be equipped with a heart rate monitor, a GPS receiver and an accelerometer for collection of heart rate, mobility and physical activity free-living data during a 7-day period. This will provide a 'spatio-behavioural diagnosis' using a map-based interactive web application. This data will be used to developed a tailored plan to promote physical activity in the child's every day environment.

Sensor based PA intervention is already approved in Canada for the following indications:

Approved in Canada as Dyn@mo lifestyle intervention for:

• Cardiometabolic risk factors in children and adolescents
• Obesity
• Hypertension
• Disorders in glucose regulation
• Dyslipidemia

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Published Research Related to This Trial

Digital self-monitoring of diet and physical activity is effective in promoting weight loss, with a mean difference of -2.87 kg and a significant reduction in calorie intake of approximately 182 calories per day, based on a meta-analysis of 12 randomized controlled trials involving adults with obesity or overweight.

Tailored interventions that provide personalized advice were found to be significantly more effective than non-tailored approaches, highlighting the importance of customization in digital self-monitoring programs for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does self-monitoring diet and physical activity behaviors using digital technology support adults with obesity or overweight to lose weight? A systematic literature review with meta-analysis. Berry, R., Kassavou, A., Sutton, S.[2021]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

A randomized clinical trial involving 445 participants showed that individual telephone counseling for obesity management significantly reduced weight regain compared to an email education control, with a posterior probability greater than 99%.

Participants receiving individual telephone counseling were more likely to achieve at least a 10% weight reduction (31.5%) compared to those in the control group (19.1%), indicating that personalized support can enhance long-term weight loss maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. Perri, MG., Shankar, MN., Daniels, MJ., et al.[2020]

A new mathematical model was developed to predict weight changes based on dietary energy intake, using data from 8 longitudinal studies with 157 participants, which showed strong accuracy in its predictions (R² values of 0.83 and 0.91).

This model can help obese patients and their doctors set realistic long-term weight maintenance goals by calculating the necessary dietary changes, making it a practical tool for weight management professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. Hall, KD., Jordan, PN.[2023]

Adherence to lifestyle-based health interventions, especially for weight loss and management, is a major challenge, with many participants struggling to maintain recommended behavior changes over the long term.

Strategies to improve long-term adherence include providing extended care, skills training, enhancing social support, and specific tactics for maintaining dietary and physical activity changes, which can help make these interventions more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Adherence to Health Behavior Change. Middleton, KR., Anton, SD., Perri, MG.[2022]

Participants in the Get Healthy Information and Coaching Service (GHS) maintained significant improvements in weight, waist circumference, and BMI six months after completing a 6-month coaching program, indicating the program's effectiveness in promoting long-term lifestyle changes.

While improvements in fruit and vegetable consumption were sustained, the increase in physical activity levels observed at the end of the program did not persist at the 12-month follow-up, suggesting a need for ongoing support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Australia's Get Healthy Information and Coaching Service: maintenance of self-reported anthropometric and behavioural changes after program completion. O'Hara, BJ., Phongsavan, P., Eakin, EG., et al.[2021]

A tailored, telephone-based physical activity coaching intervention significantly reduced Body Mass Index (BMI) by 7.4% in a higher support group of severely obese women, while the other groups either increased or showed minimal change in BMI.

Both the higher and lower support groups experienced substantial increases in physical activity (39% and 30%, respectively), demonstrating that coaching can effectively enhance physical activity levels in this population compared to a decline in the awareness group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to increase physical activity and reduce obesity in a predominantly African American group of women with mobility disabilities and severe obesity. Rimmer, JH., Rauworth, A., Wang, E., et al.[2022]

The Coaching on Lifestyle programme (CooL) effectively helped adults achieve sustained improvements in motivation, lifestyle behaviors, quality of life, and weight over an 18-month period.

While adults showed significant positive changes, the program had mixed results for children and their parents, indicating that different strategies may be needed to engage younger participants effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. van Rinsum, C., Gerards, S., Rutten, G., et al.[2019]

Bariatric patients were found to be highly sedentary, averaging only 5.6 minutes of moderate-to-vigorous physical activity (MVPA) per day, despite a daily step count of 7403 steps, indicating a need for increased physical activity post-surgery.

There was a significant discrepancy between self-reported and sensor-based physical activity, with only 17.1% of patients meeting the MVPA guidelines of 150 minutes per week based on objective measures, while 94.3% claimed adherence through self-reports, highlighting the importance of using sensor-based monitoring for accurate assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Need for Objective Physical Activity Measurements in Routine Bariatric Care. Kuipers, E., Timmerman, J., van Det, M., et al.[2022]

A comprehensive lifestyle modification program can lead to a significant weight loss of about 10% of initial body weight within 16 to 26 weeks, especially when delivered through group or individual on-site treatments.

Long-term weight control is enhanced by ongoing contact with healthcare providers, high physical activity levels, and the use of medications alongside lifestyle changes, which also help in reducing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification for the management of obesity. Wadden, TA., Butryn, ML., Wilson, C.[2022]

In a study involving 6013 participants aged 45-70, a community screening program successfully identified overweight and obese individuals at high cardiovascular risk, leading to lifestyle counseling aimed at achieving a weight reduction of at least 5%.

After three years, 18% of participants achieved the weight loss goal, while 70% maintained their weight, highlighting the effectiveness of community-based interventions; however, factors like depressive symptoms and alcohol use negatively impacted weight management success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care-based, targeted screening programme to promote sustained weight management. Korhonen, PE., Järvenpää, S., Kautiainen, H.[2021]

Citations

1.

ijbnpa.biomedcentral.com

ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-8-41

Electronic feedback in a diet- and physical activity-based ...

The primary aim of this study was to evaluate how continuous self-monitoring using the SWA affected weight loss and waist circumference ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12371298/

Guideline-Based Digital Exercise Interventions for Reducing ...

Digitally delivered physical exercise interventions are becoming increasingly popular in addressing the obesity epidemic.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8663673/

Digital Interventions on Healthy Lifestyle Management

This study aims to evaluate the impact of digital interventions on weight management in maintaining a healthy lifestyle.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667368125000336

Integrating digital health into pediatric obesity management

Participants in the intervention group showed a significant reduction in BMI z-score and percentage overweight, along with increased MVPA (+7.4 ​min/day) and ...

5.

bmcdigitalhealth.biomedcentral.com

bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00145-1

The association of physical activity, heart rate and sleep from ...

Personalizing lifestyle interventions by self-monitoring with wearable sensors can enhance adherence and improve intervention outcomes.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5480209/

the IDEA Randomized Clinical Trial - PMC

This randomized trial examined whether adding wearable technology to a behavioral intervention would improve weight loss across 24 months among ...

7.

nature.com

nature.com/articles/s41746-021-00539-9

Randomized trial of two artificial intelligence coaching ...

The wearable sensor transmitted 5 weeks' worth of physical activity data of each participant—1-week baseline physical activity data, and 4 weeks ...

8.

mhealth.jmir.org

mhealth.jmir.org/2019/10/e12612/

Assessment of the Efficacy, Safety, and Effectiveness of ...

Objective: The aim of this study was to identify efficacy, safety, and effectiveness criteria used to assess weight control, overweight, and ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8477296/

Smartphone-Based Interventions to Reduce Sedentary ...

This review aims to quantify the number of studies that have used dynamic models to develop smartphone-based interventions to promote PA and reduce SB.