Web-based Physical Activity Intervention to Promote Physical Activity

NCT05803304 | Completed

• 2 other identifiers: STUDY000051687R56HL164737-02
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Physical activity

Outcome Measures

Primary Outcomes (4)

• Change in Weekly Moderate-to-Vigorous Physical Activity

  Participants will wear a physical activity tracker around their waist for 7 days to assess the number of minutes of MVPA.

  Baseline, Month 6

• Change in Number of Participants Adhering to PA Guidelines

  Adherence to PA Guidelines will be defined as achieving ≥150 min of MVPA per week. Percent change in adherence is calculated as: \[(Post-intervention MVPA - Baseline MVPA)/Recommended MVPA×100\].

  Baseline, Month 6

• Change in Step Count

  Daily step count will be measured with a physical activity tracker worn on the wrist for at least 10 hours per day while awake.

  Baseline, Month 6

• Change in 2013 Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator

  The algorithm provides sex and race-specific estimates for the first CVD event for black and white men and women. The scores range from 0-100% with higher scores representing poor cardiovascular health status. The between group difference in risk score change is computed as the end of study score minus the baseline score.

  Baseline, Month 6

Secondary Outcomes (10)

• Change in Waist Circumference

  Baseline, Month 6

• Change in Weight

  Baseline, Month 6

• Change in Systolic Blood Pressure

  Baseline, Month 6

• Change in Diastolic Blood Pressure

  Baseline, Month 6

• Change in Life's Essential 8™ Score

  Baseline, Month 6

Study Arms (2)

PATH Intervention

EXPERIMENTAL

Insufficiently active adults with obesity assigned to the PATH intervention.

Behavioral: PATH Intervention; Other: Physical activity tracker; Behavioral: Dietary education

Attention Control Group

ACTIVE COMPARATOR

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.

Behavioral: Attention Control Intervention; Other: Physical activity tracker; Behavioral: Dietary education

Interventions

PATH Intervention 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).

PATH Intervention

Attention Control Intervention 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.

Attention Control Group

Physical activity tracker 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.

Also known as: Fitbit

Attention Control Group; PATH Intervention

Dietary education 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; PATH Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 40101744 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jacob Kariuki, PhD, NP

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: October 16, 2023
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available for sharing one year after publication of study outcomes.
• Access Criteria: Individual participant data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal. Proposal should be directed to jacob.kariuki@emory.edu. To gain access, data requesters will need to sign a data access agreement.

Locations

US (1)