Clinical trial NCT06127251: Active You: Walk, Dance, and Tone Your Abs to Reduce Your Risk of Diabetes
Official title: A Pilot Randomized Clinical Trial of Walking, Dance, and Abdominal Core Workouts to Improve Adipocytokines Among Insufficiently Active Adults With Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Physical Activity
Workouts
Adipocytokines
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Center for Diabetes Translation Research
name: American Diabetes Association
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-11-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Attainment of recruitment goal
timeFrame: 4 months after screening procedures start
measure: Participants' satisfaction of protocol procedures (acceptability)
timeFrame: 12 weeks
measure: Adherence to protocol procedures
timeFrame: 12 weeks
measure: Retention Rate in each group
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in adiponectin and leptin
timeFrame: Baseline and 12 weeks
measure: Changes in Monocyte Chemoattractant Protein-1 (MCP-1)
timeFrame: Baseline and 12 weeks
measure: Changes in proinflammatory cytokines
timeFrame: Baseline and 12 weeks
measure: Changes in T2D risk score
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change in exercise self-efficacy questionnaire (EXSE)
timeFrame: Baseline and 12 weeks
measure: Change in exercise self-regulation
timeFrame: Baseline and 12 weeks
measure: Change in the physical activity (PA) enjoyment
timeFrame: Baseline and 12 weeks
measure: Change in the social support questionnaire (SSQ) score
timeFrame: Baseline and 12 weeks
measure: Change in the Outcome Expectations for Exercise Scale questionnaires.
timeFrame: Baseline and 12 weeks
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Jacob Kariuki, PhD, NP
role: PRINCIPAL_INVESTIGATOR
References: