Clinical Trials Directory

Trials / Completed

CompletedNCT05803304

Web-based Physical Activity Intervention to Promote Physical Activity

Efficacy of a Novel Web-based Physical Activity Intervention Designed to Promote Adherence to Physical Activity Guidelines in Adults With Obesity

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
89 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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 our 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 study, 88 insufficiently active adults with obesity will be assigned to either the PATH intervention or the attention control group for 6 months.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPATH 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 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).
BEHAVIORALAttention 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 participant to the key strategies used in the booklet and encouraged 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 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.
OTHERPhysical activity trackerParticipants 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.
BEHAVIORALDietary 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 PDF addressing a diet component focused on improving diet quality to reduce CVD risk and improve general health.

Timeline

Start date
2023-10-16
Primary completion
2025-03-13
Completion
2025-03-13
First posted
2023-04-07
Last updated
2025-03-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05803304. Inclusion in this directory is not an endorsement.