What side effects are associated with this type of intervention?

Common treatments for obesity that focus on increasing physical activity and reducing sedentary time, such as those in the Dyn@mo lifestyle intervention, generally have minimal side effects. However, some individuals may experience musculoskeletal injuries, fatigue, or exacerbation of pre-existing conditions if physical activity is not appropriately tailored to their fitness level. Behavioral interventions aimed at modifying diet and exercise habits can sometimes lead to psychological stress or frustration, particularly if weight loss goals are not met. Overall, these interventions are considered safe and beneficial when properly supervised.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, often in conjunction with lifestyle interventions that promote physical activity and reduce sedentary time. Notable examples include semaglutide, which has shown significant weight loss benefits when combined with lifestyle modifications, and liraglutide, which is also used to support weight loss through similar mechanisms. These drugs are often part of comprehensive treatment plans that include dietary changes and increased physical activity, aligning with the goals of the Dyn@mo lifestyle intervention.

What other types of research exist?

<ol> <li>Smartphone App-Based Lifestyle Interventions: These include wearable activity trackers, smartscales, food photography logs, and app-based behavioral coaching with peer support.</li> </ol> They have shown efficacy in promoting weight loss and physical activity. 2. Text Messaging-Assisted Interventions: Daily text messages prompting lifestyle goals, combined with coaching calls and group sessions, have demonstrated positive outcomes in weight management. 3. Web-Based Weight-Loss Programs: Structured programs supported by web platforms that provide tailored dietary and exercise prescriptions, often based on a Mediterranean diet, have shown promise in clinical trials.

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Lifestyle Promotion Intervention for Obesity (CIRCUIT Trial)

N/A

Recruiting

Research Sponsored by St. Justine's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children ages 6 to 18 years of age with a BMI > 95th percentile for age and sex

Be younger than 65 years old

Must not have

Children with a physical or psychological condition that would impair their ability to participate in physical activity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a lifestyle intervention that uses wearable sensors to gather data on a person's physical activity. The intervention is designed to promote physical activity and reduce sedentary time to improve cardiometabolic risk factors such as obesity, hypertension, and disorders in glucose regulation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve counseling and promoting physical activity, there are no direct medical side effects. However, increased activity could potentially lead to muscle soreness or injury if not properly supervised.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in physical activity levels

Secondary study objectives

Change in blood pressure

Change in body mass index

Change in glucose homeostasis

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Traditional PA counselingExperimental Treatment1 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 interventionExperimental Treatment1 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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, particularly those similar to the Dyn@mo lifestyle intervention, focus on increasing physical activity and reducing sedentary time through data-driven counseling. These interventions work by creating a caloric deficit, where energy expenditure exceeds caloric intake, leading to weight loss. Physical activity boosts energy expenditure, while dietary modifications help reduce caloric intake. Behavioral counseling supports these changes by addressing psychological and social factors, making it easier for patients to maintain a healthy lifestyle. This approach is vital for obesity patients as it not only promotes weight loss but also enhances overall cardiometabolic health, thereby reducing the risk of associated conditions like diabetes and cardiovascular disease.

The effectiveness of interventions to treat obesity in survivors of childhood brain tumors: a systematic review protocol.A randomised trial of an Internet weight control resource: the UK Weight Control Trial [ISRCTN58621669].