Web-based Physical Activity Intervention to Promote Physical Activity

NCT ID: NCT05803304

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-03-13

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 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

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

PATH Intervention

Insufficiently active adults with obesity assigned to the PATH intervention.

Group Type: EXPERIMENTAL

PATH Intervention

Intervention Type: BEHAVIORAL

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 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).

Physical activity tracker

Intervention Type: OTHER

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.

Dietary education

Intervention Type: BEHAVIORAL

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 PDF addressing a diet component focused on improving diet quality to reduce CVD risk and improve general health.

Attention Control Group

Insufficiently active adults with obesity assigned to the attention control group. At the end of the 6-month study period, participants will receive access to the PATH program, without the coaching component.

Group Type: ACTIVE_COMPARATOR

Attention Control Intervention

Intervention Type: BEHAVIORAL

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 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.

Physical activity tracker

Intervention Type: OTHER

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.

Dietary education

Intervention Type: BEHAVIORAL

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 PDF addressing a diet component focused on improving diet quality to reduce CVD risk and improve general health.

Interventions

PATH Intervention

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 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).

Intervention Type: BEHAVIORAL

Attention Control Intervention

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 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.

Intervention Type: BEHAVIORAL

Physical activity tracker

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.

Intervention Type: OTHER

Dietary education

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 PDF addressing a diet component focused on improving diet quality to reduce CVD risk and improve general health.

Intervention Type: BEHAVIORAL

Other Intervention Names

Fitbit

Eligibility Criteria

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/wk)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Jacob Kariuki

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob Kariuki, PhD, NP

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

References

Kariuki J, Burke L, Erickson K, Sereika S, Paul S, Cheng J, Biza H, Abdirahman A, Wilbraham K, Milton H, Brown C, Sells M, Osei Baah F, Wells J, Chandler R, Barone Gibbs B. Acceptability and Preliminary Efficacy of a Novel Web-Based Physical Activity for the Heart (PATH) Intervention Designed to Promote Physical Activity in Adults With Obesity: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 18;14:e67972. doi: 10.2196/67972.

Reference Type: DERIVED

PMID: 40101744 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

7R56HL164737-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005168

Identifier Type: -

Identifier Source: org_study_id