Clinical trial NCT04621045: Active You: Feasibility of a Unique Physical Activity Program to Prevent Diabetes and Heart Disease
Official title: Feasibility and Preliminary Efficacy of a Novel YouTube Based Physical Activity Intervention in Overweight and Obese Adults at High Risk of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Prediabetes
Overweight and Obesity
Sedentary Behavior
Keywords: Physical activity
Web-based
YouTube
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will randomize 52 participants to either the PATH treatment group or wait-list control group.
Primary purpose: PREVENTION

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.

Detailed description: Currently, only 20% of American adults attain the minimum 150 mins/week of MVPA recommended by the 2018 PA Guidelines for Americans. The low levels of PA are associated with the rising prevalence of obesity and T2D. Individuals who are overweight/obese need a higher volume of PA (\~200-300 mins of weekly MVPA) to mitigate cardiometabolic risk, but they face complex multifaceted barriers that decrease their engagement in PA. Multiple studies exploring barriers and facilitators of PA among these individuals have emphasized the need for interventions that address weight-related impediments (e.g., stigma, fitness) and environmental barriers such as limited access to fitness facilities. In the last 2 decades web-based PA programs have been developed to address these barriers and to provide more interactive resources than those typically mailed to participants in home-based programs. In a recent analytic review of web-based PA interventions, 44 out of 72 studies reported significant increases in PA. However, 10 out of 13 studies focusing on adults who are overweight/obese reported no significant improvements in PA. Most of these studies employed interventions that are typically used in the general population (e.g., learning modules, email feedback, chat sessions) without adapting them to address barriers that are unique to individuals who are overweight/obese. Formative studies and social cognitive theory supports the need for PA interventions that feature individuals who are overweight/obese engaging in PA to motivate action and demonstrate success. In recent years, Internet ubiquity and creation of YouTube has enabled fitness experts across the globe to develop and share a wide variety of high quality workout videos designed to make PA convenient and enjoyable for all demographics. The investigators leveraged these resources and the aforementioned preference data to design an action-oriented PATH program tailored for individuals who are overweight/obese. The workout videos curated on PATH website were vetted by the study team and stakeholders. The investigators contribution in this project is expected to be a detailed understanding of how open sourced resources in interventions like PATH are received and utilized by overweight/obese adults.

Eligibility criteria: Inclusion Criteria:

1. 40-70 years old
2. BMI≥25
3. Have regular access to the internet (via computer or smart phone)
4. Less than 90 mins of self-reported moderate to vigorous physical activity per week
5. American Diabetes Association (ADA) risk ≥5
6. Available for pre and post-intervention assessments.

Exclusion Criteria:

1. Unstable conditions that may require supervised PA
2. Physical limitations that may prohibit engagement in MVPA
3. Pregnancy or intention to become pregnant during study, history of CVD
4. Current participation in a PA study.

Primary outcomes:
measure: Recruitment feasibility
timeFrame: At the end of study approximately 48 weeks after commencement of the study
measure: Feasibility of self-monitoring step count using wrist worn ActiGraph GT9X
timeFrame: At the end of study approximately 52 weeks after commencement of the study
measure: Acceptability of PATH intervention
timeFrame: At the end of study approximately 52 weeks after commencement of the study
Secondary outcomes:
measure: Change from baseline in body mass index (BMI) at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in body fat percentage at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in waist circumference at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in blood pressure (BP) at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in glycated hemoglobin (HbA1C) at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in lipids at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in the risk score for diabetes at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in step count at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in light physical activity at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in moderate to vigorous physical activity (MVPA) at 12 weeks
timeFrame: Post-intervention at 12 weeks
measure: Change from baseline in Barriers Exercise Self-efficacy (BARSE) scale at 12 weeks
timeFrame: Post-intervention at 12 weeks
Other outcomes:
Locations:
city: Beaver Falls
country: United States
facility: Primay Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jacob Kariuki, PhD
role: PRINCIPAL_INVESTIGATOR
References: