ObesityNCT06127251
Active You: Walk, Dance, and Tone Your Abs to Reduce Your Risk of Diabetes
A study testing PATH Intervention, Physical activity tracker and Dietary education in people with Obesity, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- PATH Intervention, Physical activity tracker and Dietary education
- Type of treatment
- Vaccines, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to 18 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)].
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Clinical Trial of Walking, Dance, and Abdominal Core Workouts to Improve Adipocytokines Among Insufficiently Active Adults With Obesity
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.
Read more
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- PATH Intervention, Control Group, Physical activity tracker, Dietary education
- Keywords
- Physical Activity, Workouts, Adipocytokines
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH InterventionBehavioural
Also called PATH
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.
Control GroupBehavioural
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 trackerDevice
Also called ScanWatch
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.
Dietary educationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| PATH Intervention | Experimental | Insufficiently active adults with obesity will be assigned to the PATH intervention. Receives: Behavioral: PATH Intervention; Device: Physical activity tracker; Behavioral: Dietary education |
| Control Group | Other | Insufficiently active adults with obesity will be assigned to the attention control group. Receives: Behavioral: Control Group; Device: Physical activity tracker; Behavioral: Dietary education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Enrolled Within 4 Months of Study Opening
Number of participants enrolled within 4 months after the study opened to enrollment.
Measured: 4 months after screening procedures start
Number of Participants Retained in Each Group
Number of participants (Retention rate) retained in each group at 12 weeks after enrollment
Measured: 12 weeks
The System Usability Scale
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.
Measured: 12 weeks
Participants' Satisfaction of Protocol Procedures (Acceptability)
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)
Measured: 12 weeks
Participants' Engagement
Participants who visited the PATH platform at least twice weekly.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
Proinflammatory Cytokines
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.
Measured: Baseline and 12 weeks
Insulin Levels
Collected via Dried Blood Spot (DBS) kits
Measured: Baseline and 12 weeks
Type 2 Diabetes (T2D) Risk Score
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start11 Apr 2024
- Primary completion18 May 2025
- Study completion18 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research, American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jacob Kariuki, Emory University
- Investigators
- Jacob Kariuki, PhD, NP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127251
- Sponsor's protocol ID
- STUDY00006632
- Other IDs
- P30DK111024
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2023
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be made available for the main study outcomes. All the deidentified data will be available for sharing if other researchers submit a data request form that will be approved by the principal investigator (PI)
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Clinical Trial of Walking, Dance, and Abdominal Core Workouts to Improve Adipocytokines Among Insufficiently Active Adults With Obesity
- ClinicalTrials.gov ID
- NCT06127251
- Acronym / sponsor ID
- STUDY00006632
- Conditions
- Obesity
- Keywords
- Physical Activity, Workouts, Adipocytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research, American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 18 May 2025 (actual)
- Study completion
- 18 May 2025 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Posted 22 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATH Intervention | Experimental | Behavioral: PATH Intervention, Device: Physical activity tracker, Behavioral: Dietary educationInsufficiently active adults with obesity will be assigned to the PATH intervention. |
| Control Group | Other | Behavioral: Control Group, Device: Physical activity tracker, Behavioral: Dietary educationInsufficiently active adults with obesity will be assigned to the attention control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)].
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PATH InterventionAlso: PATHThe 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. | Behavioural | PATH Intervention |
| Control GroupStudy 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. | Behavioural | Control Group |
| Physical activity trackerAlso: ScanWatchParticipants 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. | Device | Control Group, PATH Intervention |
| Dietary educationThe 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 | Behavioural | Control Group, PATH Intervention |
Primary outcome
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.
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
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.
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)
Participants' Engagement
Time frame: 12 weeks
Participants who visited the PATH platform at least twice weekly.
5 secondary outcomes
Adiponectin and Leptin
Time frame: Baseline and 12 weeks
Monocyte Chemoattractant Protein-1 (MCP-1)
Time frame: Baseline and 12 weeks
Proinflammatory Cytokines
Time frame: Baseline and 12 weeks
Insulin Levels
Time frame: Baseline and 12 weeks
Type 2 Diabetes (T2D) Risk Score
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be made available for the main study outcomes. All the deidentified data will be available for sharing if other researchers submit a data request form that will be approved by the principal investigator (PI)
Related trials for Obesity
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of Exercise Training on Breastmilk Composition
Obesity
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Kariuki, PhD, NP principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATH Intervention, Physical activity tracker and Dietary education in people with Obesity, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Enrolled Within 4 Months of Study Opening (time frame: 4 months after screening procedures start). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.