Cardiovascular Diseases
Conditions
Keywords
Physical activity
Brief 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.
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.
Interventions
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).
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.
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Moderate-to-Vigorous Physical Activity Measured With FitBit | 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 | 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 | 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 | 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. |
| Weekly Moderate-to-Vigorous Physical Activity Measured With ActiGraph | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | Baseline, Month 6 | Weight is measured in pounds (lbs). The change from Baseline to Month 6 was assessed for both study arms. |
| Systolic Blood Pressure | Baseline, Month 6 | 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). |
| Diastolic Blood Pressure | Baseline, Month 6 | 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. |
| Change in Life's Essential 8™ Score | Baseline, Month 6 | 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. |
| Change in Adiponectin | Baseline, Month 6 | 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. |
| Hemoglobin A1c (HbA1c) | Baseline, Month 6 | 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. |
| Total Cholesterol | Baseline, Month 6 | 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. |
| Low-density Lipoprotein (LDL) Cholesterol | Baseline, Month 6 | 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. |
| High-density Lipoprotein (HDL) Cholesterol | Baseline, Month 6 | 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. |
| Waist Circumference | Baseline, Month 6 | Waist circumference is measured in inches. |
Countries
United States
Contacts
Emory University
Participant flow
Recruitment details
Participants were recruited through Emory University in Atlanta, Georgia, USA. Participant enrollment began October 16, 2023 and all follow-up assessments were completed by March 13, 2025.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.66 years STANDARD_DEVIATION 12.17 |
| Meeting PA guidelines, measured by ActiGraph | 20 Participants |
| Race/Ethnicity, Customized Black/African American | 22 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 41 Participants |
| Region of Enrollment United States | 45 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 8 Participants |
| Weight | 245.56 pounds (lbs) STANDARD_DEVIATION 45.96 |
| Weight loss medication use | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 44 |
| other Total, other adverse events | 5 / 45 | 9 / 44 |
| serious Total, serious adverse events | 2 / 45 | 1 / 44 |