Cardiovascular Risk FactorNCT04280783
Active You: A Novel Exercise Program for African Americans
A study testing The Physical Activity for The Heart (PATH) intervention and Be Active Your Way Booklet in people with Cardiovascular Risk Factor and Prediabetes, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Barriers to physical activity (PA) among African Americans (AAs) have been extensively studied, yet there is a paucity of innovative PA interventions designed to address them. In recent years, many studies have used the internet to promote PA in many settings, including the home environment, but only a few studies… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Prediabetes, Overweight and Obesity
- What is being tested?
- The Physical Activity for The Heart (PATH) intervention and Be Active Your Way Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Oct 2020to 31 Dec 2021
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-70 years old
- BMI≥25
- Have regular access to the internet (via computer or smart phone)
- Less than 90 mins of self-reported moderate to vigorous physical activity per week
- American Diabetes Association (ADA) risk ≥5
- Available for pre and post-intervention assessments.
- Self-identify as Black/African American
Who cannot join
- Unstable conditions that may require supervised PA
- Physical limitations that may prohibit engagement in MVPA
- Pregnancy or intention to become pregnant during study, history of CVD
- Current participation in a PA study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Primay Health Network
Beaver Falls, Pennsylvania, 15010
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Feasibility and Acceptability of a Web-based Physical Activity for the Heart (PATH) Intervention Designed to Reduce the Risk of Heart Disease Among Inactive African Americans
Barriers to physical activity (PA) among African Americans (AAs) have been extensively studied, yet there is a paucity of innovative PA interventions designed to address them. In recent years, many studies have used the internet to promote PA in many settings, including the home environment, but only a few studies have recruited AAs. Without innovative and culturally relevant interventions, AAs will continue reporting extremely low levels of PA and disparate cardiovascular health outcomes. In prior work, the investigators sought the input of AA focus groups to inform the development of a technology-based Physical Activity for The Heart (PATH) intervention that leverages openly accessible platforms, such as YouTube, to promote PA in any setting. The investigators designed PATH as a culturally salient action-oriented intervention that can be accessed in any setting to promote PA among inactive AAs. In this application, the investigators propose to examine whether PATH is a feasible strategy for promoting PA among inactive AAs. In Aim 1 the investigators will conduct a randomized clinical trial that will include 30 inactive AAs to assess the feasibility and acceptability of the PATH intervention. In Aim 2 the investigators will examine the trend in PA and cardiovascular disease risk change from baseline to post-intervention. This approach is innovative because it leverages openly accessible technologies to provide a wide variety of free, enjoyable and action-oriented workout videos that match AAs preferences. This contribution will be significant because PATH could offer a novel, low-cost, and scalable strategy for promoting PA among individuals facing socio-environmental barriers to PA.
Read the detailed description
Whereas an inverse dose-response relationship has been established between physical activity (PA) and a host of chronic illnesses, including cardiovascular disease (CVD), most American adults (79%) are physically inactive and do not attain the minimum PA levels recommended by the PA Guidelines for Americans. African Americans (AAs) in particular report very low levels of PA, and have the highest burden of CVD in the United States.To eliminate the prevailing cardiovascular health disparities, there is a critical need for pragmatic and culturally salient interventions that are designed to address barriers to PA that are more problematic for AAs.
Common barriers to PA such as lack of time and low exercise self-efficacy are pervasive in all racial groups. In addition to these barriers, socio-environmental factors, such as unsafe neighborhoods and limited access to fitness facilities play a key role in perpetuating the low levels of PA observed in AAs. To mitigate these barriers, home-based PA interventions delivered via mail, telephone and internet have been developed. Although only a few of these interventions have been tested among AAs, preliminary studies have reported more participation and retention of AAs in home-based PA programs. However, the associated PA outcomes have been minimal, especially in less educated AAs. Low literacy levels and reliance on print-based resources with no cultural appeal are thought to limit the utility of the interventions in AAs. The investigators have previously reported how AAs prefer PA programs that are visual, convenient, fun to engage in, and feature people they can relate to especially in body size, fitness status and age. Other studies have reported similar preferences for PA among AAs, yet there is a paucity of PA interventions that are designed to incorporate these preferences.
To bridge this gap, the investigators have developed a web-based Physical Activity for The Heart (PATH) intervention that leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the reported preferences. Currently, PATH includes 90 workout videos vetted using the FITT principle (frequency, intensity, time, type) and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA. The overarching aim of the proposed study is to conduct a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the PATH intervention for promoting PA in AAs. The investigators will enroll 30 inactive AAs and randomize them to either treatment (12-wks of PATH) or wait-list control (use a general health handout) group to address the following specific aims:
Aim 1: Assess the feasibility and acceptability of the PATH intervention among inactive AAs. Feasibility will be assessed via 1) number of participants screened for eligibility; 2) percentage eligible; 3) percentage enrolled; 4) percentage retained within each randomized group; and 5) adherence to self-monitoring (Actigraph wear time) and intervention protocol (PATH utilization). Acceptability will be evaluated via a post-intervention survey developed by the study team to appraise the intervention's usability and perceived efficacy for increasing PA.
Aim 2: Describe the trends in PA and CVD risk change from baseline to post-intervention. The primary outcome will be PA and will include objectively measured steps, light PA, and moderate-to-vigorous PA (MVPA). Cardiovascular outcomes will include blood pressure (BP), body fat percentage, body mass index (BMI), glycated hemoglobin (HbA1c) and lipids (LDL, HDL, and total cholesterol). Trends will be summarized as mean within-group changes (with 95% confidence intervals [CIs]).
The proposed research addresses a key driver of cardiovascular health disparities and is innovative in its rigorous testing of the novel PATH intervention for feasibility and acceptability among inactive AAs. Findings from this study will inform the refinement of the PATH intervention to be tested in a full-scale RCT.
- Being tested
- The Physical Activity for The Heart (PATH) intervention, Be Active Your Way Booklet
- Keywords
- Physical activity, Web-based, YouTube, Remote
- Medical subject headings
- Prediabetic State, Overweight, Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Physical Activity for The Heart (PATH) interventionBehavioural
The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.
Be Active Your Way BookletBehavioural
Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
| Study group | Role | What they receive |
|---|---|---|
| PATH Treatment Group | Experimental | The PATH group will be granted password protected access to one of the 3 PATH levels based on their baseline fitness status. The intervention is designed to help participants increase their baseline PA via health coaching, self-monitoring and pragmatic workout videos that provide convenient options for overcoming socio-environmental barriers to PA. Receives: Behavioral: The Physical Activity for The Heart (PATH) intervention |
| Wait-list control group | Other | Participants in this group will not have access to the PATH intervention until after 12 weeks when they cross over. After randomization, the control group will be provided with a copy of the Be Active Your Way booklet, developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. Receives: Behavioral: Be Active Your Way Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Retained at the End of Study
Will be indicated by the number of enrolled participants who are retained by the end of the study.
Measured: Post-intervention at 12 weeks
Percentage of Participants Who Self-monitored Step Count Using Wrist Worn ActiGraph GT9X Over the Study Period
will be indicated by the proportion of the sample with ≥4days per week of valid Actigraph wear time (≥10hrs) during the entire course of the study.
Measured: Post-intervention at 12 weeks
Acceptability of PATH Intervention
Percentage of participants who reported the PATH platform was culturally appropriate
Measured: Post-intervention at 12 weeks
Secondary outcomes (10)
Body Mass Index (BMI) at 12 Weeks
BMI will be measured using Fitbit Aria II scale provided to the participant by the study team. The study team will guide the participants on how to measure their BMI and will supervise the measurement via HIPAA compliant Zoom session.
Measured: Post-intervention at 12 weeks
Change From Baseline in Body Fat Percentage at 12 Weeks
Body fat percentage will be measured using Fitbit Aria II scale provided to the participant by the study team. The study team will guide the participants on how to measure their body fat and will supervise the measurement via HIPAA compliant Zoom session.
Measured: Post-intervention at 12 weeks
Change From Baseline in Waist Circumference at 12 Weeks
Waist circumference will be measured using Perfect waist tape measure provided to the participant by the study team. The study team will guide the participants on how to take the measurement using a standard video and will be able to observe the outcome of the measurement via HIPAA compliant Zoom session.
Measured: Post-intervention at 12 weeks
Change From Baseline in Systolic Blood Pressure (SBP) at 12 Weeks
Both diastolic and systolic BP will be reported. The measurement will be done using automated OMRON BP machine provided to the participant by the study team. The study team will guide the participants on how to take blood pressure and will supervise the measurement via HIPAA compliant Zoom session.
Measured: Post-intervention at 12 weeks
Change From Baseline in Glycated Hemoglobin (HbA1C) at 12 Weeks
The sample for HbA1C will be collected by participants at home using the dry blood spot method. The study team will guide the participants on how to take the sample using a standard video and will supervise the collection via HIPAA compliant Zoom session. The sample will be processed by CoreMedica lab using standard protocols
Measured: Post-intervention at 12 weeks
Change From Baseline in Total Cholesterol at 12 Weeks
The blood sample for lipids (total cholesterol) will be collected by participants at home using the dry blood spot method. The study team will guide the participants on how to take the sample using a standard video and will supervise the collection via HIPAA compliant Zoom session. The sample will be processed by CoreMedica lab using standard protocols.
Measured: Post-intervention at 12 weeks
Change From Baseline in the Risk Score for Diabetes at 12 Weeks
The risk score for diabetes will be measured via the American Diabetes Association (ADA) Risk Calculator. The scores range from 0 to 10 with higher scores indicating high risk for developing type 2 diabetes.
Measured: Post-intervention at 12 weeks
Change From Baseline in Step Count at 12 Weeks
Step count will be measured using a wrist worn ActiGraph GT9X link during the entire study period. The study outcomes will focus on change from baseline to 12 weeks
Measured: Post-intervention at 12 weeks
Moderate to Vigorous Physical Activity
Change from baseline in moderate to vigorous physical activity (MVPA) at 12 weeks measured using a waist worn ActiGraph GT3X accelerometer
Measured: Post-intervention at 12 weeks
Change From Baseline in Barriers Exercise Self-efficacy (BARSE) Scale at 12 Weeks
Participants will be asked to respond to the BARSE scale appraising their exercise self-efficacy. The scale range from 0 to 100, with higher scores indicating increased exercise self-efficacy
Measured: Post-intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start27 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 Risk FactorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will randomize 30 participants to either the PATH treatment group or wait-list control group.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Jacob Kariuki, University of Pittsburgh
- Investigators
- Jacob Kariuki, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280783
- Sponsor's protocol ID
- STUDY19110217
- Other IDs
- 5UL1TR001857-04
- Status last verified
- Oct 2024
- First submitted
- 19 Feb 2020
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is our goal to make all data generated from this proposal available to other investigators without compromising the confidentiality of participants. Investigators who would like to do a secondary analysis of de-identified data can submit a formal request for the data including the proposal of their intended analysis to the PI at activeu@pitt.edu. The PI will review all requests and facilitate data access once approval is granted.
Publications
Kariuki JK, Sereika S, Erickson K, Burke LE, Kriska A, Cheng J, Milton H, Hirshfield S, Ogutu D, Gibbs B. Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial. Contemp Clin Trials. 2023 Oct;133:107318. doi: 10.1016/j.cct.2023.107318. Epub 2023 Aug 23.
PubMed 37625586
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Web-based Physical Activity for the Heart (PATH) Intervention Designed to Reduce the Risk of Heart Disease Among Inactive African Americans
- ClinicalTrials.gov ID
- NCT04280783
- Acronym / sponsor ID
- STUDY19110217
- Keywords
- Physical activity, Web-based, YouTube, Remote
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Posted 4 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Barriers to physical activity (PA) among African Americans (AAs) have been extensively studied, yet there is a paucity of innovative PA interventions designed to address them. In recent years, many studies have used the internet to promote PA in many settings, including the home environment, but only a few studies have recruited AAs. Without innovative and culturally relevant interventions, AAs will continue reporting extremely low levels of PA and disparate cardiovascular health outcomes. In prior work, the investigators sought the input of AA focus groups to inform the development of a technology-based Physical Activity for The Heart (PATH) intervention that leverages openly accessible platforms, such as YouTube, to promote PA in any setting. The investigators designed PATH as a culturally salient action-oriented intervention that can be accessed in any setting to promote PA among inactive AAs. In this application, the investigators propose to examine whether PATH is a feasible strategy for promoting PA among inactive AAs. In Aim 1 the investigators will conduct a randomized clinical trial that will include 30 inactive AAs to assess the feasibility and acceptability of the PATH intervention. In Aim 2 the investigators will examine the trend in PA and cardiovascular disease risk change from baseline to post-intervention. This approach is innovative because it leverages openly accessible technologies to provide a wide variety of free, enjoyable and action-oriented workout videos that match AAs preferences. This contribution will be significant because PATH could offer a novel, low-cost, and scalable strategy for promoting PA among individuals facing socio-environmental barriers to PA.
Detailed description
Whereas an inverse dose-response relationship has been established between physical activity (PA) and a host of chronic illnesses, including cardiovascular disease (CVD), most American adults (79%) are physically inactive and do not attain the minimum PA levels recommended by the PA Guidelines for Americans. African Americans (AAs) in particular report very low levels of PA, and have the highest burden of CVD in the United States.To eliminate the prevailing cardiovascular health disparities, there is a critical need for pragmatic and culturally salient interventions that are designed to address barriers to PA that are more problematic for AAs.
Common barriers to PA such as lack of time and low exercise self-efficacy are pervasive in all racial groups. In addition to these barriers, socio-environmental factors, such as unsafe neighborhoods and limited access to fitness facilities play a key role in perpetuating the low levels of PA observed in AAs. To mitigate these barriers, home-based PA interventions delivered via mail, telephone and internet have been developed. Although only a few of these interventions have been tested among AAs, preliminary studies have reported more participation and retention of AAs in home-based PA programs. However, the associated PA outcomes have been minimal, especially in less educated AAs. Low literacy levels and reliance on print-based resources with no cultural appeal are thought to limit the utility of the interventions in AAs. The investigators have previously reported how AAs prefer PA programs that are visual, convenient, fun to engage in, and feature people they can relate to especially in body size, fitness status and age. Other studies have reported similar preferences for PA among AAs, yet there is a paucity of PA interventions that are designed to incorporate these preferences.
To bridge this gap, the investigators have developed a web-based Physical Activity for The Heart (PATH) intervention that leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the reported preferences. Currently, PATH includes 90 workout videos vetted using the FITT principle (frequency, intensity, time, type) and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA. The overarching aim of the proposed study is to conduct a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the PATH intervention for promoting PA in AAs. The investigators will enroll 30 inactive AAs and randomize them to either treatment (12-wks of PATH) or wait-list control (use a general health handout) group to address the following specific aims:
Aim 1: Assess the feasibility and acceptability of the PATH intervention among inactive AAs. Feasibility will be assessed via 1) number of participants screened for eligibility; 2) percentage eligible; 3) percentage enrolled; 4) percentage retained within each randomized group; and 5) adherence to self-monitoring (Actigraph wear time) and intervention protocol (PATH utilization). Acceptability will be evaluated via a post-intervention survey developed by the study team to appraise the intervention's usability and perceived efficacy for increasing PA.
Aim 2: Describe the trends in PA and CVD risk change from baseline to post-intervention. The primary outcome will be PA and will include objectively measured steps, light PA, and moderate-to-vigorous PA (MVPA). Cardiovascular outcomes will include blood pressure (BP), body fat percentage, body mass index (BMI), glycated hemoglobin (HbA1c) and lipids (LDL, HDL, and total cholesterol). Trends will be summarized as mean within-group changes (with 95% confidence intervals [CIs]).
The proposed research addresses a key driver of cardiovascular health disparities and is innovative in its rigorous testing of the novel PATH intervention for feasibility and acceptability among inactive AAs. Findings from this study will inform the refinement of the PATH intervention to be tested in a full-scale RCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will randomize 30 participants to either the PATH treatment group or wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| PATH Treatment Group | Experimental | Behavioral: The Physical Activity for The Heart (PATH) interventionThe PATH group will be granted password protected access to one of the 3 PATH levels based on their baseline fitness status. The intervention is designed to help participants increase their baseline PA via health coaching, self-monitoring and pragmatic workout videos that provide convenient options for overcoming socio-environmental barriers to PA. |
| Wait-list control group | Other | Behavioral: Be Active Your Way BookletParticipants in this group will not have access to the PATH intervention until after 12 weeks when they cross over. After randomization, the control group will be provided with a copy of the Be Active Your Way booklet, developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 40-70 years old
- BMI≥25
- Have regular access to the internet (via computer or smart phone)
- Less than 90 mins of self-reported moderate to vigorous physical activity per week
- American Diabetes Association (ADA) risk ≥5
Key exclusion criteria (4 listed)
- Unstable conditions that may require supervised PA
- Physical limitations that may prohibit engagement in MVPA
- Pregnancy or intention to become pregnant during study, history of CVD
- Current participation in a PA study.
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 |
|---|---|---|
| The Physical Activity for The Heart (PATH) interventionThe web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle. | Behavioural | PATH Treatment Group |
| Be Active Your Way BookletBe Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do. | Behavioural | Wait-list control group |
Primary outcome
Percentage of Participants Retained at the End of Study
Time frame: Post-intervention at 12 weeks
Will be indicated by the number of enrolled participants who are retained by the end of the study.
Percentage of Participants Who Self-monitored Step Count Using Wrist Worn ActiGraph GT9X Over the Study Period
Time frame: Post-intervention at 12 weeks
will be indicated by the proportion of the sample with ≥4days per week of valid Actigraph wear time (≥10hrs) during the entire course of the study.
Acceptability of PATH Intervention
Time frame: Post-intervention at 12 weeks
Percentage of participants who reported the PATH platform was culturally appropriate
10 secondary outcomes
Body Mass Index (BMI) at 12 Weeks
Time frame: Post-intervention at 12 weeks
Change From Baseline in Body Fat Percentage at 12 Weeks
Time frame: Post-intervention at 12 weeks
Change From Baseline in Waist Circumference at 12 Weeks
Time frame: Post-intervention at 12 weeks
Change From Baseline in Systolic Blood Pressure (SBP) at 12 Weeks
Time frame: Post-intervention at 12 weeks
Change From Baseline in Glycated Hemoglobin (HbA1C) at 12 Weeks
Time frame: Post-intervention at 12 weeks
Change From Baseline in Total Cholesterol at 12 Weeks
Time frame: Post-intervention at 12 weeks
Change From Baseline in the Risk Score for Diabetes at 12 Weeks
Time frame: Post-intervention at 12 weeks
Change From Baseline in Step Count at 12 Weeks
Time frame: Post-intervention at 12 weeks
Moderate to Vigorous Physical Activity
Time frame: Post-intervention at 12 weeks
Change From Baseline in Barriers Exercise Self-efficacy (BARSE) Scale at 12 Weeks
Time frame: Post-intervention at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37625586Kariuki JK, Sereika S, Erickson K, Burke LE, Kriska A, Cheng J, Milton H, Hirshfield S, Ogutu D, Gibbs B. Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial. Contemp Clin Trials. 2023 Oct;133:107318. doi: 10.1016/j.cct.2023.107318. Epub 2023 Aug 23.
- Individual participant dataSharing planned: Yes. It is our goal to make all data generated from this proposal available to other investigators without compromising the confidentiality of participants. Investigators who would like to do a secondary analysis of de-identified data can submit a formal request for the data including the proposal of their intended analysis to the PI at activeu@pitt.edu. The PI will review all requests and facilitate data access once approval is granted.
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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 principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Physical Activity for The Heart (PATH) intervention and Be Active Your Way Booklet in people with Cardiovascular Risk Factor and Prediabetes, run by University of Pittsburgh at 2 sites 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 7 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 Dec 2023). 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?
Percentage of Participants Retained at the End of Study (time frame: Post-intervention at 12 weeks). The study lists 3 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 NCT04280783, 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 5 Nov 2024.