Active You: Feasibility of a Unique Physical Activity Program to Prevent Diabetes and Heart Disease
Feasibility and Preliminary Efficacy of a Novel YouTube Based Physical Activity Intervention in Overweight and Obese Adults at High Risk of Type 2 Diabetes
1 other identifier
interventional
52
1 country
2
Brief Summary
Individuals who are overweight/obese are more vulnerable to type 2 diabetes (T2D). Current evidence suggests that PA, even without dietary prescription, can be efficacious in preventing T2D. Yet most Americans, especially those who are overweight/obese, are not physically active. Socioenvironmental barriers to physical activity (PA) such as body image concerns and limited access to fitness facilities contribute to the low levels of PA observed in overweight/obese adults. Web-based PA programs have been developed to address these barriers, but the outcomes have been marginal. Qualitative studies suggest that individuals who are overweight/obese prefer PA programs that feature people they can relate to especially in body size, fitness status and age. Previously, the investigators have included these preferences in a technology-based Physical Activity for The Heart (PATH) intervention that leverages open source platforms, such as YouTube, to promote PA in any setting. In this application, the investigators propose to test the feasibility and preliminary efficacy of PATH in promoting PA and reducing cardiometabolic risk in adults who are overweight/obese and at high risk of diabetes. In Aim 1 the investigators will conduct a 12-week randomized clinical trial including 52 adults who are overweight/obese and at high risk of diabetes to assess the feasibility and acceptability of PATH. In Aim 2 investigators will examine the trend in PA and cardiometabolic risk change from baseline to post-intervention. This approach is innovative because it leverages open source technologies to provide low-cost, action-oriented PA resources that match the preferences of adults who are overweight/obese. This contribution will be significant because PATH could offer a convenient, enjoyable and scalable program that features "similar others" to promote PA in overweight/obese adults at high risk of diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2020
CompletedFirst Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2022
CompletedOctober 7, 2022
October 1, 2022
1.4 years
November 2, 2020
October 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Recruitment feasibility
Will be indicated by ability to recruit, screen, and enroll the target sample within 6 months of commencing recruitment, and retention of ≥80% of the sample.
At the end of study approximately 48 weeks after commencement of the study
Feasibility of self-monitoring step count using wrist worn ActiGraph GT9X
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.
At the end of study approximately 52 weeks after commencement of the study
Acceptability of PATH intervention
Will be indicated by utilization data that will be collected via Web analytics, and a post-intervention survey will assess the intervention acceptability.
At the end of study approximately 52 weeks after commencement of the study
Secondary Outcomes (11)
Change from baseline in body mass index (BMI) at 12 weeks
Post-intervention at 12 weeks
Change from baseline in body fat percentage at 12 weeks
Post-intervention at 12 weeks
Change from baseline in waist circumference at 12 weeks
Post-intervention at 12 weeks
Change from baseline in blood pressure (BP) at 12 weeks
Post-intervention at 12 weeks
Change from baseline in glycated hemoglobin (HbA1C) at 12 weeks
Post-intervention at 12 weeks
- +6 more secondary outcomes
Study Arms (2)
PATH Treatment Group
EXPERIMENTALThe 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
ACTIVE COMPARATORParticipants 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Primay Health Network
Beaver Falls, Pennsylvania, 15010, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (1)
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.
PMID: 37625586DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Kariuki, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 9, 2020
Study Start
October 27, 2020
Primary Completion
March 12, 2022
Study Completion
March 12, 2022
Last Updated
October 7, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 12 months after the end of the study
- Access Criteria
- Data access will be provided based on scientific merit of the proposed analysis, IRB approval and data agreement contract as deemed appropriate by University of Pittsburgh
t 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.