Active You: Walk, Dance, and Tone Your Abs to Reduce Your Risk of Diabetes
- Conditions
- Obesity
- Interventions
- Behavioral: PATH InterventionBehavioral: Control GroupDevice: Physical activity trackerBehavioral: Dietary education
- Registration Number
- NCT06127251
- Lead Sponsor
- Emory University
- Brief Summary
The phenomenon of physical activity (PA) avoidance in obesity has been detailed in the literature, but there is a lack of programs designed to address the root causes. In addition to common PA barriers such as lack of time, individuals with obesity face weight-related impediments, including stigma, shame, poor fitness, and low exercise self-efficacy, which reduce their engagement in PA. These impediments have been observed in white and minoritized populations. Numerous studies have suggested that individuals with obesity prefer activities that are enjoyable, less exhausting, and conveniently available in settings where they are not exposed to stigma. The studies also point to a need for programs that focus on the general health benefits of PA rather than weight loss, which although desirable, can be elusive.
Unmet weight loss expectations contribute to high dropout rates and non-adherence to the prescribed PA regimen among those with obesity. This is particularly consequential for minoritized populations including African Americans who tend to lose less weight in lifestyle interventions but achieve significant improvements in many cardiometabolic outcomes.
In this proposal, investigators present PA as a buffer against the deleterious effects of obesity, agnostic of weight loss status.
The Physical Activity for The Heart (PATH) program was intentionally designed to provide vicarious experiences for diverse individuals with obesity, by featuring their peers in body size, fitness level, and age engaging in PA.
The impact of the PATH intervention on these biomarkers will provide important insights into the mechanisms via which a combination of popular PA modalities improves cardiometabolic outcomes in the context of obesity.
- Detailed Description
The proposed research is significant because it will provide key evidence supporting the use of curated, openly sourced content to address PA barriers in obesity. Physical Activity for The Heart (PATH) intervention, which is anchored on the social cognitive theory's (SCT) premise that observing similar (i.e. body type, fitness level, age) others succeed can motivate action and help demonstrate a plan for success.
Thus proposal will examine the feasibility of using PATH in a weight-neutral context and the preliminary effects on adipocytokines that influence insulin resistance. If PATH improves PA and adipocytokines, it could provide a highly scalable tool for mitigating the risk of cardiometabolic disease, especially among those looking for weight-agnostic PA programs. The walking, dance, and abdominal core workouts to be examined in this proposal are extremely popular and abundant on YouTube, which makes it easy to access and curate content that can be tailored to individual preferences.
The highly scalable PATH program is accessible at any time in any setting and can lessen the impact of unpredictable barriers to PA such as inclement weather or pandemics.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- age ≥18 years, body mass index (BMI) ≥30kg/m2,
- regular access to the Internet,
- self-monitoring of PA via waist worn Actigraph during run-in (≥4 days with ≥10hrs wear time),
- self-reported non-adherence to PA Guidelines [<150 min of moderate to vigorous physical activities (MVPA/wk)].
- pregnancy/intention to become pregnant within 12 weeks,
- involvement in litigation related to a health issue, or a condition that requires supervised PA (e.g., stroke).
- Individuals with a history of cerebrovascular disease (CVD), type 2 diabetes (T2D),
- any affirmative response to any question in the Physical Activity Readiness Questionnaire (PAR-Q) will require primary care physician (PCP) clearance before enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PATH Intervention PATH Intervention Insufficiently active adults with obesity will be assigned to the PATH intervention. PATH Intervention Dietary education Insufficiently active adults with obesity will be assigned to the PATH intervention. Control Group Physical activity tracker Insufficiently active adults with obesity will be assigned to the attention control group. Control Group Control Group Insufficiently active adults with obesity will be assigned to the attention control group. PATH Intervention Physical activity tracker Insufficiently active adults with obesity will be assigned to the PATH intervention. Control Group Dietary education Insufficiently active adults with obesity will be assigned to the attention control group.
- Primary Outcome Measures
Name Time Method Retention Rate in each group 12 weeks Retention rate in each group at 12 weeks after enrollment
Participants' satisfaction of protocol procedures (acceptability) 12 weeks Satisfaction by participants will be measured with neutral messages/content collected via an end-of-study survey on user experience.
Adherence to protocol procedures 12 weeks Proportion of the sample who adhere to key study procedures (e.g., regular self-monitoring of PA, attendance of coaching sessions)
Attainment of recruitment goal 4 months after screening procedures start Percentage of recruitment goal achieved within 4 months
- Secondary Outcome Measures
Name Time Method Changes in Monocyte Chemoattractant Protein-1 (MCP-1) Baseline and 12 weeks MCP-1 is one of the key chemokines that regulate the migration and infiltration of monocytes/macrophages. MCP-1 will be collected via dry blood spot kits. A significant decline in MCP-1 will indicate improved adipocytokine and cardiometabolic risk profile and vice versa.
Changes in T2D risk score Baseline and 12 weeks The calculation of the American Diabetes Association (ADA) T2D risk score includes covariates such as age, sex, family history of diabetes, history of high blood pressure (BP), body mass index, and PA regimen (total score of 0-11). Scores ≥5 should be formally screened for diabetes per ADA guidelines.
Changes in adiponectin and leptin Baseline and 12 weeks Adiponectin is a hormone released by adipose tissue and other body tissues, which assists with insulin sensitivity and reduces inflammation. Normal ranges vary depending on sex and BMI and in general lower levels are associated with health conditions of obesity, Type 2 diabetes, and atherosclerosis. Adiponectin and leptin will be collected via dry blood spot kits. A significant increase in adiponectin and decline in leptin, and T2D risk score will indicate improved adipocytokine and cardiometabolic risk profile and vice versa.
Changes in proinflammatory cytokines Baseline and 12 weeks Proinflammatory cytokines: tumor necrosis factor Alpha (TNF-α), Interleukin-1 beta (IL1β), and Interleukin-6 (IL6) will be collected via dry blood spot kits. A significant decline in TNF-α, IL1β, and IL6 will indicate improved adipocytokine and cardiometabolic risk profile and vice versa.
Trial Locations
- Locations (1)
Emory University
🇺🇸Atlanta, Georgia, United States