Lifestyle Promotion Intervention for Obesity
(CIRCUIT Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: St. Justine's Hospital
Disqualifiers: Physical, psychological conditions, others
No Placebo Group
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.12345
Is the Lifestyle Promotion Intervention for Obesity safe for humans?
How is the Sensor-based Physical Activity Intervention for obesity different from other treatments?
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.
Trial 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 (Behavioral Intervention)
- Traditional PA counseling (Behavioral Intervention)
Trial OverviewThis 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
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CHU Sainte-JustineMontreal, Canada
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Who Is Running the Clinical Trial?
St. Justine's HospitalLead Sponsor
References
Primary care-based, targeted screening programme to promote sustained weight management. [2021]To identify overweight and obese subjects at increased cardiovascular risk in the community, and provide them with lifestyle counselling that is possible to implement in real life.
Modeling weight-loss maintenance to help prevent body weight regain. [2023]Lifestyle intervention can successfully induce weight loss in obese persons, at least temporarily. However, there currently is no way to quantitatively estimate the changes of diet or physical activity required to prevent weight regain. Such a tool would be helpful for goal-setting, because obese patients and their physicians could assess at the outset of an intervention whether long-term adherence to the calculated lifestyle change is realistic.
The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. [2019]Combined lifestyle interventions (CLIs) can be effective in reducing weight and improving lifestyle-related behaviours but it is unclear how CLIs can best be implemented in practice in order to achieve sustained lifestyle changes. The Coaching on Lifestyle programme (CooL) is a CLI in the Netherlands, in which professional lifestyle coaches counsel adults and children (and/or their parents) who are obese or at high risk of obesity to achieve a sustained healthier lifestyle. The CooL intervention consists of group and individual sessions addressing the topics of physical activity, dietary behaviours, sleep and stress. Our longitudinal one-group pre-post study aimed to identify lifestyle changes among participants (adults, children and their parents) at 8 and 18 months after initiation. We assessed constructs ranging from motivation and behaviour-specific cognitions to behaviours and health outcomes. Positive and sustained changes among adults were found regarding perceived autonomy, motivation, perceived barriers, lifestyle behaviours, quality of life and weight. Among children and their parents, few improvements were found regarding behaviours and quality of life. CooL has been successful in coaching adult participants towards sustained behavioural change during the intervention period. Mixed results and smaller effect sizes were found for children and their parents.
Weight Loss Strategies. [2022]Lifestyle interventions for weight loss combine support for changing diet and physical activity with weight management education and are considered the first line treatment for obesity. A variety of diet-focused interventions including time-restricted eating are also increasingly being promoted for weight management. This chapter reviews different types of interventions for weight management, their underlying health behavior change models, and effectiveness to date in randomized trials. The results justify increasing efforts to improve program effectiveness generally, and to personalize interventions to support long-term adherence. The high prevalence of obesity worldwide, combined with the known increase in risk of non-communicable diseases with duration of excess weight, provides a compelling justification for routine delivery of effective weight management interventions in the community and in clinical care.
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]Establish whether digital self-monitoring of diet and physical activity is effective at supporting weight loss, increasing physical activity and improving eating behavior in adults with obesity or overweight, and determine the intervention components that might explain variations in its effectiveness. A systematic search of MEDLINE, Embase, PsycINFO, Web of Science, Scopus, Cinahl, and CENTRAL identified 4068 studies, of which 12 randomized controlled trials were eligible and included in the review. A random-effect meta-analysis evaluated intervention effectiveness and subgroup analyses tested for effective intervention content. Twelve studies were included in the review and meta-analysis. Digital self-monitoring of both diet and physical activity had a statistically significant effect at supporting weight loss (mean difference [MD] = -2.87 [95% CI -3.78, -1.96], P < 0.001, I2  = 69%), improving moderate physical activity (standardized mean difference [SMD] = 0.44 [95% CI 0.26, 0.62], P < 0.001, I2  = 0%), and reducing calorie intake (MD = -181.71 [95% CI -304.72, -58.70], P < 0.01, I2  = 0%). Tailored interventions were significantly more effective than nontailored interventions (x2  = 12.92, P < 0.001). Digital self-monitoring of physical activity and diet is an effective intervention to support weight loss in adults with obesity or overweight. This effect is significantly associated with tailored advice. Future studies should use rigorous designs to explore intervention effectiveness to support weight loss as an adjunct to weight management services.
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]This randomized controlled trial tested a tailored, telephone-based physical activity coaching intervention for a predominantly African American group of women with severe obesity and mobility disability.
The Need for Objective Physical Activity Measurements in Routine Bariatric Care. [2022]This study aims to (1) quantify physical behavior through self-reports and sensor-based measures, (2) examine the correlation between self-reported and sensor-based physical activity (PA) and (3) assess whether bariatric patients adhere to PA guidelines.
Lifestyle modification for the management of obesity. [2022]Several expert panels have recommended that obese individuals attempt to lose 10% of their initial body weight through a combination of diet, physical activity, and behavior therapy (frequently referred to as lifestyle modification). This article reviews the short-and long-term results of lifestyle modification and methods to improve them. Randomized controlled trials were examined that compared different diet and activity interventions for inducing and maintaining weight loss. Studies that compared different methods of providing lifestyle modification, including on-site vs. Internet-based delivery, also were examined. A comprehensive lifestyle modification program was found to induce a loss of approximately 10% of initial weight in 16 to 26 weeks of group or individual treatment, delivered on-site. Comprehensive Internet-based programs induced a loss of approximately half this size. Patients' consumption of portion-controlled diets, including liquid meal replacements, was associated with significantly greater short-term weight loss than was the consumption of isocaloric diets comprised of conventional foods. Factors associated with long-term weight control included continued patient-practitioner contact (whether on-site or by e-mail), high levels of physical activity, and the long-term use of pharmacotherapy combined with lifestyle modification. In summary, lifestyle modification induces clinically significant weight loss that is associated with the prevention or amelioration of cardiovascular risk factors.
Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]The translation of an evidence-based lifestyle intervention to an online delivery format has the potential to provide an effective treatment option for obesity in primary care practice. Research is needed, however, to standardize e-counseling procedures to promote the training of health coaches and the dissemination to primary care settings. This article describes the development of an online lifestyle intervention coaching protocol adapted from the Diabetes Prevention Program lifestyle intervention curriculum.
Long-Term Adherence to Health Behavior Change. [2022]The utility of lifestyle-based health promotion interventions is directly impacted by participant adherence to prescribed behavior changes. Unfortunately, poor adherence to behaviors recommended in lifestyle interventions is widespread, particularly over the long-term; thus, the "adherence problem" represents a significant challenge to the effectiveness of these interventions. The current review provides an overview of the adherence problem and describes a theoretical framework through which the factors that impact adherence can be understood. To further understand the difficulties individuals face when adhering to health behavior changes, we focus our discussion on challenges associated with adherence to lifestyle behaviors recommended for weight loss and healthy weight management (i.e., reductions in dietary intake and increases in physical activity). We describe strategies that improve long-term adherence to health behaviors related to healthy weight management, including the provision of extended care, skills training, improving social support, and strategies specific to maintaining changes in dietary intake and physical activity. Finally, we discuss difficulties involved in implementing long-term weight management programs and suggest practical solutions for providers.
Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. [2020]Lifestyle interventions for obesity produce reductions in body weight that can decrease risk for diabetes and cardiovascular disease but are limited by suboptimal maintenance of lost weight and inadequate dissemination in low-resource communities.
Effectiveness of Australia's Get Healthy Information and Coaching Service: maintenance of self-reported anthropometric and behavioural changes after program completion. [2021]The Get Healthy Information and Coaching Service (GHS) is a population-wide telephone-based program aimed at assisting adults to implement lifestyle improvements. It is a relatively uncommon example of the translation of efficacious trials to up-scaled real-world application. GHS participants who completed the 6-month coaching program made significant initial improvements to their weight, waist circumference, Body Mass Index (BMI), physical activity and nutrition behaviours. This study examines the maintenance of anthropometric and behaviour change improvements 6-months after program completion.