Cardiovascular DiseasesNCT05803304
Web-based Physical Activity Intervention to Promote Physical Activity
A study testing PATH Intervention, Physical activity tracker and Dietary education in people with Cardiovascular Diseases, run by Emory University at 1 site in United States.
Trial summary
In this study insufficiently active adults with obesity will be assigned to either the Physical Activity for The Heart (PATH) intervention or an attention control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- PATH Intervention, Physical activity tracker and Dietary education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 13 Mar 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
- Regular access to the Internet
- BMI ≥30kg/m^2
- Successful self-monitoring of PA (≥4 days with ≥10hrs wear time) via waist worn Actigraph
- Non-adherence to the PA Guidelines (<150 min of MVPA/week)
Who cannot join
- Pregnancy or intention to become pregnant within 6 months
- Mobility restrictions, or any condition that requires supervised PA (e.g., stroke)
- Individuals with history of heart disease, diabetes, or those who respond in affirmative to any question in the Physical Activity Readiness Questionnaire will be required to obtain Primary Care Provider (PCP) clearance before enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Novel Web-based Physical Activity Intervention Designed to Promote Adherence to Physical Activity Guidelines in Adults With Obesity
In this study insufficiently active adults with obesity will be assigned to either the Physical Activity for The Heart (PATH) intervention or an attention control group.
Read the detailed description
The United States' 2018 Physical Activity Guidelines recommend that American adults should achieve ≥150 min of moderate intensity physical activity (PA), 75 min of vigorous PA, or an equivalent combination of both moderate and vigorous physical activity (MVPA) weekly. Yet, adherence to these Guidelines is low, with 26% of adults with normal weight and 14% of adults with obesity attaining the minimum recommended PA levels. The low PA levels are associated with the rising prevalence of obesity and increase the relative risk of stroke, coronary heart disease, and diabetes by 60%2, 45%, and 30%, respectively. Since individuals with obesity are more vulnerable to cardiovascular disease (CVD) and its risk factors, weight loss is recommended. Yet, even without weight-loss, PA significantly reduces CVD risk. However, individuals with obesity face complex multifaceted barriers that reduce their engagement in PA.
Barriers to PA associated with obesity include stigma, shame, poor fitness, and low self-efficacy. These evoke fear of embarrassment and pain, contributing to aversion of PA. To mitigate these barriers, web-based PA programs targeting adults with obesity have been developed. Preliminary data suggest improved retention, but the effects on PA are heterogeneous. Limitations of these interventions include lack of human contact, 'one-size-fits-all' strategies, unmet weight-loss expectations, and generic content that fails to address the barriers associated with obesity. Researchers have reported that individuals with obesity prefer programs that are convenient, fun to engage in, and feature people who they can relate to in body size, fitness level, and age. Yet, there is a paucity of PA interventions intentionally designed to flexibly incorporate these preferences.
To address the limitations of previous interventions, the research team of this study designed the web-based Physical Activity for The Heart (PATH) intervention. PATH leverages openly accessible platforms, such as YouTube, to provide workout videos that match the specific preferences expressed in formative studies and the extant literature. In developing PATH, the researchers employed an iterative bottom-up approach where the target population was engaged in the selection and rating of the workout videos. Then, highly rated workouts (≥3.5/5 stars) were vetted by the study team for content relevance and safety, and then curated on the PATH website in 3 intensity levels (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA. The researchers added backend features that enable a remote health coach to help users set their PA goals and select a PA regimen that is safe for their fitness level. Each PATH user has a personalized dashboard displaying their recommended workouts and progress towards their PA goals.
In this pilot feasibility trial, 88 insufficiently active adults with obesity are assigned to either the PATH intervention or the attention control group for 6 months. The primary aims of the study are to examine feasibility and acceptability of the PATH intervention.
- Conditions
- Cardiovascular Diseases
- Being tested
- PATH Intervention, Attention Control Intervention, Physical activity tracker, Dietary education
- Keywords
- Physical activity
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH InterventionBehavioural
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support long-term adherence to the minimum threshold of PA Guidelines (150 MVPA minutes per week). The health coach provides participants with access to the PATH website and a detailed orientation 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 by about 10 minutes per week. The PA prescription process begins by identifying a suitable PATH level for each participant. 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. The coach also guides participants to select activities with intensity to help them progress along the PA continuum (i.e., from inactive to light PA and then MVPA).
Attention Control InterventionBehavioural
A health coach will have a zoom meeting with each control group participant where they will be provided with an electronic copy of the "Be Active Your Way" booklet, developed by the Centers for Disease Control and Prevention (CDC) to help individuals integrate PA into their daily lives. The coach will orient the participants to the key strategies used in the booklet and encourage them to use it regularly and to self-monitor PA using the Fitbit during the entire course of the study. In addition, the group will be introduced to www.health.com, a jargon free website that focuses on general health topics and latest medical news. At the end of the meeting, the participants will be asked to provide a schedule for zoom meetings with the study team twice per month during the 6-month study. The meetings will focus on their progress in using the "Be Active Your Way" handout and the health.com website.
Physical activity trackerOther
Also called Fitbit
Participants will be asked to wear Fitbit Charge 5 on their non-dominant hand for the entire duration of the study using a 24hr wear protocol.
Dietary educationBehavioural
Diet quality and barriers to healthy eating will be evaluated at baseline, and then all study participants will be provided with educational materials that are curated to promote diet quality. Participants will receive a monthly email with a brief Portable Document Format (PDF) addressing a diet component focused on improving diet quality to reduce CVD risk and improve general health.
| Study group | Role | What they receive |
|---|---|---|
| PATH Intervention | Experimental | Insufficiently active adults with obesity assigned to the PATH intervention. Receives: Behavioral: PATH Intervention; Other: Physical activity tracker; Behavioral: Dietary education |
| Attention Control Group | Active comparator | Insufficiently active adults with obesity assigned to the attention control group. At the end of the 6-month study period, participants will receive access to the PATH program, without the coaching component. Receives: Behavioral: Attention Control Intervention; Other: Physical activity tracker; Behavioral: Dietary education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Moderate-to-Vigorous Physical Activity Measured With ActiGraph
Participants wore a physical activity tracker, the ActiGraph GT3X+ accelerometer, around their waist for 7 days at Baseline and Month 6 to assess the number of minutes of moderate-to-vigorous physical activity (MVPA) per week.
Measured: Baseline, Month 6
Weekly Moderate-to-Vigorous Physical Activity Measured With FitBit
Participants wore a FitBit physical activity tracker on their wrist to assess the number of minutes of moderate-to-vigorous physical activity (MVPA) per week.The FitBit wrist activity tracker was worn for at least 10 hours per day while awake.
Measured: Baseline, Month 6
Number of Participants by Change in Physical Activity (PA) Guidelines Adherence
Adherence to PA Guidelines is defined as achieving ≥150 minutes of moderate-to-vigorous physical activity (MVPA) per week. The number of participants adhering to ≥150 minutes of MVPA per week between the Baseline and Month 6 assessments were examined.
Measured: Baseline, Month 6
Step Count
Daily step count is measured with a FitBit physical activity tracker worn on the wrist for at least 10 hours per day while awake.
Measured: Baseline, Month 6
2013 Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator Score
The algorithm provides sex and race-specific estimates for the first CVD event for black and white men and women. Scores are calculated using age, diabetes status (no or yes), sex, smoking status (no or yes), total cholesterol, HDL cholesterol, systolic blood pressure, and treatment for hypertension (no or yes). Dried blood spot (DBS) samples for total cholesterol and HDL cholesterol - the lipid values required to calculate the 2013 ASCVD Risk Calculator Score - were collected from participants at Baseline and Month 6. ASCVD scores range from 0-100% with higher scores representing poor cardiovascular health status.
Measured: Baseline, Month 6
Secondary outcomes (10)
Waist Circumference
Waist circumference is measured in inches.
Measured: Baseline, Month 6
Change in Weight
Weight is measured in pounds (lbs). The change from Baseline to Month 6 was assessed for both study arms.
Measured: Baseline, Month 6
Systolic Blood Pressure
Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Normal systolic blood pressure as lower than 120 millimeters of mercury (mmHg).
Measured: Baseline, Month 6
Diastolic Blood Pressure
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Normal diastolic blood pressure as lower than 80 mmHg.
Measured: Baseline, Month 6
Change in Life's Essential 8™ Score
Life's Essential 8 is a way to assess cardiovascular health developed by the American Heart Association. Life's Essential 8 has 8 components: diet, physical activity, exposure to nicotine, sleep, body mass index (BMI), blood lipids, blood glucose, and blood pressure. Each component is scored with an algorithm and scores range from 0 to 100. A composite score of overall cardiovascular health can be generated and it also ranges from 0 to 100. A score of 0 indicates a low health score, a score of 50 indicates moderate health, and a score of 100 is the highest health for each of the 8 components as well as the overall score.
Measured: Baseline, Month 6
Hemoglobin A1c (HbA1c)
The hemoglobin A1c test result reflects average blood sugar level over the past three months. Specifically, the A1c test measures what percentage of hemoglobin is coated with sugar (glycated). Values below 5.7% are normal, values between 5.7% and 6.4% indicate prediabetes, and values of 6.5% and higher indicate diabetes. Dried blood spots (DBS) were collected for assessing HbA1c at Baseline and Month 6 per protocol.
Measured: Baseline, Month 6
Change in Adiponectin
Adiponectin is a hormone released by adipose tissue, and other body tissues, that assists with insulin sensitivity and reducing 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. In people with a BMI of less than 25, the normal range for males and females is 5 to 37 micrograms per milliliter (µg/mL). In those with a BMI of 25 to 30 the normal range for males is 5 to 28 µg/mL and the normal range for females is 4 to 20 µg/mL. In people with a BMI over 30 the normal range for males is 2 to 20 µg/mL and the normal range for females is 4 to 22 µg/mL.
Measured: Baseline, Month 6
Total Cholesterol
Cholesterol is waxy substance which is produced by the liver or comes from food that is consumed. Cholesterol concentrations are commonly used as a marker for cardiovascular disease risk. Healthy levels of total cholesterol are 125 to 200 milligrams (mg) per deciliter (dL). Dried blood spot (DBS) samples for total cholesterol were collected from participants per protocol at Baseline and Month 6.
Measured: Baseline, Month 6
Low-density Lipoprotein (LDL) Cholesterol
Dried blood spot (DBS) samples for LDL cholesterol were collected from participants per protocol at Baseline and Month 6. Healthy levels of LDL cholesterol are below 100mg/dL.
Measured: Baseline, Month 6
High-density Lipoprotein (HDL) Cholesterol
HDL cholesterol is the "good" cholesterol because it is a type of fat that removes cholesterol from blood, thereby preventing build up. Healthy levels for HDL cholesterol are 40mg/dL or higher in adult males and 50 mg/dL or higher in adult females. Dried blood spot (DBS) samples for HDL cholesterol were collected from participants per protocol at Baseline and Month 6.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start16 Oct 2023
- Primary completion13 Mar 2025
- Study completion13 Mar 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jacob Kariuki, Emory University
- Investigators
- Jacob Kariuki, PhD, NP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803304
- Sponsor's protocol ID
- STUDY00005168
- Other IDs
- 7R56HL164737-02, 2024P008695
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2023
- Last updated
- 12 Aug 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. Other data from the questionnaires or other assessments may be available for sharing on a case-by-case basis.
Publications
Kariuki J, Burke L, Erickson K, Sereika S, Paul S, Cheng J, Biza H, Abdirahman A, Wilbraham K, Milton H, Brown C, Sells M, Osei Baah F, Wells J, Chandler R, Barone Gibbs B. Acceptability and Preliminary Efficacy of a Novel Web-Based Physical Activity for the Heart (PATH) Intervention Designed to Promote Physical Activity in Adults With Obesity: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 18;14:e67972. doi: 10.2196/67972.
PubMed 40101744
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Web-based Physical Activity Intervention Designed to Promote Adherence to Physical Activity Guidelines in Adults With Obesity
- ClinicalTrials.gov ID
- NCT05803304
- Acronym / sponsor ID
- STUDY00005168
- Conditions
- Cardiovascular Diseases
- Keywords
- Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Posted 12 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study insufficiently active adults with obesity will be assigned to either the Physical Activity for The Heart (PATH) intervention or an attention control group.
Detailed description
The United States' 2018 Physical Activity Guidelines recommend that American adults should achieve ≥150 min of moderate intensity physical activity (PA), 75 min of vigorous PA, or an equivalent combination of both moderate and vigorous physical activity (MVPA) weekly. Yet, adherence to these Guidelines is low, with 26% of adults with normal weight and 14% of adults with obesity attaining the minimum recommended PA levels. The low PA levels are associated with the rising prevalence of obesity and increase the relative risk of stroke, coronary heart disease, and diabetes by 60%2, 45%, and 30%, respectively. Since individuals with obesity are more vulnerable to cardiovascular disease (CVD) and its risk factors, weight loss is recommended. Yet, even without weight-loss, PA significantly reduces CVD risk. However, individuals with obesity face complex multifaceted barriers that reduce their engagement in PA.
Barriers to PA associated with obesity include stigma, shame, poor fitness, and low self-efficacy. These evoke fear of embarrassment and pain, contributing to aversion of PA. To mitigate these barriers, web-based PA programs targeting adults with obesity have been developed. Preliminary data suggest improved retention, but the effects on PA are heterogeneous. Limitations of these interventions include lack of human contact, 'one-size-fits-all' strategies, unmet weight-loss expectations, and generic content that fails to address the barriers associated with obesity. Researchers have reported that individuals with obesity prefer programs that are convenient, fun to engage in, and feature people who they can relate to in body size, fitness level, and age. Yet, there is a paucity of PA interventions intentionally designed to flexibly incorporate these preferences.
To address the limitations of previous interventions, the research team of this study designed the web-based Physical Activity for The Heart (PATH) intervention. PATH leverages openly accessible platforms, such as YouTube, to provide workout videos that match the specific preferences expressed in formative studies and the extant literature. In developing PATH, the researchers employed an iterative bottom-up approach where the target population was engaged in the selection and rating of the workout videos. Then, highly rated workouts (≥3.5/5 stars) were vetted by the study team for content relevance and safety, and then curated on the PATH website in 3 intensity levels (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA. The researchers added backend features that enable a remote health coach to help users set their PA goals and select a PA regimen that is safe for their fitness level. Each PATH user has a personalized dashboard displaying their recommended workouts and progress towards their PA goals.
In this pilot feasibility trial, 88 insufficiently active adults with obesity are assigned to either the PATH intervention or the attention control group for 6 months. The primary aims of the study are to examine feasibility and acceptability of the PATH intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATH Intervention | Experimental | Behavioral: PATH Intervention, Other: Physical activity tracker, Behavioral: Dietary educationInsufficiently active adults with obesity assigned to the PATH intervention. |
| Attention Control Group | Active comparator | Behavioral: Attention Control Intervention, Other: Physical activity tracker, Behavioral: Dietary educationInsufficiently active adults with obesity assigned to the attention control group. At the end of the 6-month study period, participants will receive access to the PATH program, without the coaching component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Regular access to the Internet
- BMI ≥30kg/m^2
- Successful self-monitoring of PA (≥4 days with ≥10hrs wear time) via waist worn Actigraph
- Non-adherence to the PA Guidelines (<150 min of MVPA/week)
Key exclusion criteria (3 listed)
- Pregnancy or intention to become pregnant within 6 months
- Mobility restrictions, or any condition that requires supervised PA (e.g., stroke)
- Individuals with history of heart disease, diabetes, or those who respond in affirmative to any question in the Physical Activity Readiness Questionnaire will be required to obtain Primary Care Provider (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 InterventionThe PATH intervention guides participants in making changes in their lifestyle and PA habits to support long-term adherence to the minimum threshold of PA Guidelines (150 MVPA minutes per week). The health coach provides participants with access to the PATH website and a detailed orientation 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 by about 10 minutes per week. The PA prescription process begins by identifying a suitable PATH level for each participant. 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. The coach also guides participants to select activities with intensity to help them progress along the PA continuum (i.e., from inactive to light PA and then MVPA). | Behavioural | PATH Intervention |
| Attention Control InterventionA health coach will have a zoom meeting with each control group participant where they will be provided with an electronic copy of the "Be Active Your Way" booklet, developed by the Centers for Disease Control and Prevention (CDC) to help individuals integrate PA into their daily lives. The coach will orient the participants to the key strategies used in the booklet and encourage them to use it regularly and to self-monitor PA using the Fitbit during the entire course of the study. In addition, the group will be introduced to www.health.com, a jargon free website that focuses on general health topics and latest medical news. At the end of the meeting, the participants will be asked to provide a schedule for zoom meetings with the study team twice per month during the 6-month study. The meetings will focus on their progress in using the "Be Active Your Way" handout and the health.com website. | Behavioural | Attention Control Group |
| Physical activity trackerAlso: FitbitParticipants will be asked to wear Fitbit Charge 5 on their non-dominant hand for the entire duration of the study using a 24hr wear protocol. | Other | Attention Control Group, PATH Intervention |
| Dietary educationDiet quality and barriers to healthy eating will be evaluated at baseline, and then all study participants will be provided with educational materials that are curated to promote diet quality. Participants will receive a monthly email with a brief Portable Document Format (PDF) addressing a diet component focused on improving diet quality to reduce CVD risk and improve general health. | Behavioural | Attention Control Group, PATH Intervention |
Primary outcome
Weekly Moderate-to-Vigorous Physical Activity Measured With ActiGraph
Time frame: Baseline, Month 6
Participants wore a physical activity tracker, the ActiGraph GT3X+ accelerometer, around their waist for 7 days at Baseline and Month 6 to assess the number of minutes of moderate-to-vigorous physical activity (MVPA) per week.
Weekly Moderate-to-Vigorous Physical Activity Measured With FitBit
Time frame: Baseline, Month 6
Participants wore a FitBit physical activity tracker on their wrist to assess the number of minutes of moderate-to-vigorous physical activity (MVPA) per week.The FitBit wrist activity tracker was worn for at least 10 hours per day while awake.
Number of Participants by Change in Physical Activity (PA) Guidelines Adherence
Time frame: Baseline, Month 6
Adherence to PA Guidelines is defined as achieving ≥150 minutes of moderate-to-vigorous physical activity (MVPA) per week. The number of participants adhering to ≥150 minutes of MVPA per week between the Baseline and Month 6 assessments were examined.
Step Count
Time frame: Baseline, Month 6
Daily step count is measured with a FitBit physical activity tracker worn on the wrist for at least 10 hours per day while awake.
2013 Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator Score
Time frame: Baseline, Month 6
The algorithm provides sex and race-specific estimates for the first CVD event for black and white men and women. Scores are calculated using age, diabetes status (no or yes), sex, smoking status (no or yes), total cholesterol, HDL cholesterol, systolic blood pressure, and treatment for hypertension (no or yes). Dried blood spot (DBS) samples for total cholesterol and HDL cholesterol - the lipid values required to calculate the 2013 ASCVD Risk Calculator Score - were collected from participants at Baseline and Month 6. ASCVD scores range from 0-100% with higher scores representing poor cardiovascular health status.
10 secondary outcomes
Waist Circumference
Time frame: Baseline, Month 6
Change in Weight
Time frame: Baseline, Month 6
Systolic Blood Pressure
Time frame: Baseline, Month 6
Diastolic Blood Pressure
Time frame: Baseline, Month 6
Change in Life's Essential 8™ Score
Time frame: Baseline, Month 6
Hemoglobin A1c (HbA1c)
Time frame: Baseline, Month 6
Change in Adiponectin
Time frame: Baseline, Month 6
Total Cholesterol
Time frame: Baseline, Month 6
Low-density Lipoprotein (LDL) Cholesterol
Time frame: Baseline, Month 6
High-density Lipoprotein (HDL) Cholesterol
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40101744Kariuki J, Burke L, Erickson K, Sereika S, Paul S, Cheng J, Biza H, Abdirahman A, Wilbraham K, Milton H, Brown C, Sells M, Osei Baah F, Wells J, Chandler R, Barone Gibbs B. Acceptability and Preliminary Efficacy of a Novel Web-Based Physical Activity for the Heart (PATH) Intervention Designed to Promote Physical Activity in Adults With Obesity: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 18;14:e67972. doi: 10.2196/67972.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be made available for the main study outcomes. Other data from the questionnaires or other assessments may be available for sharing on a case-by-case basis.
Related trials for Cardiovascular Diseases
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
RecruitingPhase 3
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Multiple Myeloma
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
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 Cardiovascular Diseases, 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 3 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 12 Aug 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 12 Aug 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?
Weekly Moderate-to-Vigorous Physical Activity Measured With ActiGraph (time frame: Baseline, Month 6). 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?
On the ClinicalTrials.gov record for NCT05803304, which also lists 1 linked publication.
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 12 Aug 2026.