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Completed

NCT Number: NCT06127251

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PATH Intervention

Behavioral

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.

Other names: PATH

Control Group

Behavioral

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 ScanWatch. 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.

Physical activity tracker

Device

Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.

Other names: ScanWatch

Dietary Education

Behavioral

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

Primary outcomes

  1. Participants Enrolled Within 4 Months of Study Opening

    Time frame: 4 months after screening procedures start

    Number of participants enrolled within 4 months after the study opened to enrollment.

  2. Number of Participants Retained in Each Group

    Time frame: 12 weeks

    Number of participants (Retention rate) retained in each group at 12 weeks after enrollment

  3. The System Usability Scale

    Time frame: 12 weeks

    The System Usability Scale (SUS) is an industry-standard, 10-item questionnaire used to evaluate the perceived usability of a product, system, or service. It provides a quick, reliable, and quantifiable measure of ease of use and user satisfaction. Users rate their level of agreement or disagreement with 10 statements using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Responses are converted and summed according to standard SUS scoring and transformed to a total score ranging from 0 to 100. The average score is about 68. A score above 68 is considered above average/good; a score below 68 is below average. Acceptability Ranges: Scores above 70 are typically considered "Acceptable," while scores below 50 usually indicate a system with poorer usability that needs to be redesigned.

  4. Participants' Satisfaction of Protocol Procedures (Acceptability)

    Time frame: 12 weeks

    Participant satisfaction was assessed using an end-of-study user experience survey. Participants rated navigation ease (extremely easy/very easy) and overall satisfaction with the content and messaging.

    Navigation ease (extremely/very easy) Cultural appropriateness (very/somewhat appropriate) Workout access (extremely/very easy) Text reminders helpful (extremely/very helpful)

  5. Participants' Engagement

    Time frame: 12 weeks

    Participants who visited the PATH platform at least twice weekly.

Secondary outcomes

  1. Adiponectin and Leptin

    Time frame: 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.

  2. Monocyte Chemoattractant Protein-1 (MCP-1)

    Time frame: 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.

  3. Proinflammatory Cytokines

    Time frame: Baseline and 12 weeks

    Proinflammatory cytokines: tumor necrosis factor Alpha (TNF-α), Interleukin-1 beta (IL1β), and Interleukin-6 (IL6), and CRP 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.

  4. Insulin Levels

    Time frame: Baseline and 12 weeks

    Collected via Dried Blood Spot (DBS) kits

  5. Type 2 Diabetes (T2D) Risk Score

    Time frame: 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.

Other outcomes

  1. Change in Exercise Self-efficacy Questionnaire (EXSE)

    Time frame: Baseline and 12 weeks

    EXSE Scale assesses an individual's beliefs in their ability to continue exercising on a three-time-per-week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). The total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.

  2. Change in Exercise Self-regulation

    Time frame: Baseline and 12 weeks

    Exercise Self-regulation involves skills for planning, organizing, and managing exercise activities. will be measured by the Exercise Goal-Setting Scale (EGS) and the Exercise Planning and Scheduling Scale (EPS). Participants will rate 10 EGS items and 10 EPS items on a 5-point scale ranging from 1 (does not describe) to 5 (describes completely). Higher levels of self-regulatory skills, such as goal-setting, self-monitoring, planning, and problem-solving, may result in higher levels of PA.

  3. Change in the Physical Activity (PA) Enjoyment

    Time frame: Baseline and 12 weeks

    The Physical Activity Enjoyment Scale is an 18-item scale that assesses enjoyment of physical activity by asking participants to rate "how do you feel at the moment about the physical activity you have been doing" using a 7- point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate).

  4. Change in the Social Support Questionnaire (SSQ) Score

    Time frame: Baseline and 12 weeks

    SSQ has two-part answer questions. It asks to list up to 9 people who provide support that meets the criteria stated in the question. The support persons are listed by initials and relationship to the participant. Participants then rate their satisfaction (1 - very dissatisfied to 6 - very satisfied) with the support of each person stated in the first part. The support score (SSQN) is calculated by the average of the individual scores across the 27 items. A high score indicates more optimism about life than a low score. Low SSQ scores have a higher prevalence of negative life events and illness.

    Add the total number of people for all 27 items. (Max. is 243). Divide by 27 for the average item score=SSQ Number Score (SSQN) Add the total satisfaction scores for all 27 items. (Max is 162). Divide by 27 for the average item score=SSQ Satisfaction score (SSQS) Average the above for the total number of family members - this results in the SSQ family score

  5. Change in the Outcome Expectations for Exercise Scale Questionnaires.

    Time frame: Baseline and 12 weeks

    The Outcome Expectations for Exercise Scale (OEE) contains 9 statements rated by participants using a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree". The OEE was made primarily to study older adults with low expectations of the effects of exercise.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • American Diabetes Association
  • Georgia Center for Diabetes Translation Research
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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