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

Trial Summary

What is the purpose of this trial?

The Dyn@mo lifestyle intervention (CHU Sainte-Justine, Quebec, Canada) targets children and adolescents aged 6 to 17 years old with cardiometabolic risk factors, such as obesity, hypertension, disorders in glucose regulation or dyslipidemia. Its primary goal is to promote physical activity and reduce sedentary time to improve childrens' cardiometabolic profile. To do so, the intervention relies on gathering data on mobility and physical activity using wearable sensors. These data provide a detailed picture of real-life conditions and physical activity levels, improving the health care professional's ability to tailor counseling. The investigators are presently in the implementation phase of this intervention.

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 data supports the effectiveness of the treatment Sensor based PA intervention, Dyn@mo lifestyle intervention, Sensor-based Physical Activity Intervention, Traditional PA counseling, Physical Activity Counseling, Lifestyle Intervention for obesity?

Research shows that lifestyle interventions, which include support for changing diet and physical activity, are effective for weight loss and are considered the first line treatment for obesity. Digital self-monitoring of diet and physical activity has also been found to significantly support weight loss and improve physical activity in adults with obesity. ^{1 2 3 4 5}

Is the Lifestyle Promotion Intervention for Obesity safe for humans?

The studies reviewed indicate that lifestyle interventions, including physical activity and dietary changes, are generally safe for humans. These interventions have been shown to support weight loss and improve lifestyle behaviors without significant safety concerns. ^{2 3 6 7 8}

How is the Sensor-based Physical Activity Intervention for obesity different from other treatments?

The Sensor-based Physical Activity Intervention is unique because it uses technology to monitor and promote physical activity, providing real-time feedback and personalized support, which can enhance adherence to lifestyle changes compared to traditional counseling methods. ^{1 9 10 11 12}

Eligibility Criteria

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.

Inclusion Criteria

My child is between 6 to 18 years old and has a BMI above the 95th percentile for their age and sex.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. [2019]

3. England 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. [2021]

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

Primary care-based, targeted screening programme to promote sustained weight management. [2021]

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

Modeling weight-loss maintenance to help prevent body weight regain. [2023]

6. United States 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. [2022]

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

The Need for Objective Physical Activity Measurements in Routine Bariatric Care. [2022]

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

Lifestyle modification for the management of obesity. [2022]

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

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]

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

Long-Term Adherence to Health Behavior Change. [2022]

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

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. [2020]

12. England 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. [2021]