Active You: Walk, Dance, and Tone Your Abs to Reduce Your Risk of Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Randomized Clinical Trial of Walking, Dance, and Abdominal Core Workouts to Improve Adipocytokines Among Insufficiently Active Adults With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: PATH Intervention
* Behavioral: Control Group
* Device: Physical activity tracker
* Behavioral: Dietary education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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)]. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PATH Intervention<br>Insufficiently active adults with obesity will be assigned to the PATH intervention. | Behavioral: PATH Intervention<br>* The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions on how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week. Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.<br>* Other names: PATH;Device: Physical activity tracker<br>* Participants will be asked to wear a Fitbit tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.<br>* Other names: Fitbit;Behavioral: Dietary education<br>* The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks<br>|
| Other: Control Group<br>Insufficiently active adults with obesity will be assigned to the attention control group. | Behavioral: Control Group<br>* Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using Fitbit. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.<br>Device: Physical activity tracker<br>* Participants will be asked to wear a Fitbit tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.<br>* Other names: Fitbit;Behavioral: Dietary education<br>* The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment of recruitment goal | Percentage of recruitment goal achieved within 4 months | 4 months after screening procedures start | 
| Acceptability of protocol procedures | Satisfaction with weight neutral messages/content collected via an end of study survey on user experience. | 12 weeks | 
| Adherence to protocol procedures | Proportion of the sample who adhere to key study procedures (e.g., regular self-monitoring of PA, attendance of coaching sessions) | 12 weeks | 
| Retention Rate in each group | Retention rate in each group at 12 weeks after enrollment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in adiponectin and leptin | 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. | Baseline and 12 weeks | 
| Changes in Monocyte Chemoattractant Protein-1 (MCP-1) | 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. | Baseline and 12 weeks | 
| Changes in proinflammatory cytokines | 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. | Baseline and 12 weeks | 
| Changes in T2D risk score | The calculation of the American Diabetes Association (ADA) T2D risk score that includes covariates such as age, sex, family history of diabetes, history of high blood pressure (BP), body mass index, and PA regimen. Scores ≥5 should be formally screened for diabetes per ADA guidelines. | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Workouts, Physical Activity, Adipocytokines