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NCT06350604 Clinical Trial

Project WHADE: A Partner-Based Physical Activity Program for Women

Hypertension Clinical Trial

Official title:
Project WHADE: A Partner-Based Physical Activity Program for Women

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06350604
Other study ID # PRO-2023-355
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2024
Est. completion date July 2024

Study information
Verified date April 2024
Source Rowan University
Contact Danielle Arigo, Ph.D.
Phone 8562564500
Email arigo@rowan.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to test the feasibility and acceptability of a new method for supporting physical activity among women ages 40-65 who have risk factors for cardiovascular disease. Each participant receives a trained physical activity coach and a physical activity partner; the partner is another woman in the program. Partners communicate with each other between weekly coaching sessions to provide support for physical activity behavior change.

Description:

The purpose of this study is to test the feasibility and acceptability of a new method for supporting physical activity in women ages 40-65 who have risk markers for cardiovascular disease. The primary goal is to understand perceptions of support and communication patterns between partner dyads of women in midlife (ages 40-65). The creation of these partner dyads is a promising method for promoting social support and physical activity for this population. Understanding how partners communicate with one another throughout this intervention study will give insight into how women in this population maximize benefits from partnership through communication and shared experiences (e.g., age, gender, cardiovascular disease risk, interest in being more physically active).

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - One or more of the following health conditions: smoking (current or quit in the last 3 months), or a physician diagnosis of prediabetes or type 2 diabetes, prehypertension or hypertension (high blood pressure), hypercholesterolemia or hyperlipidemia(high cholesterol), or metabolic syndrome - Engaging in less in less than 6500 steps per day or less than 90 minutes of structured exercise per week - Access to personal mobile device - Fluent in English Exclusion Criteria: - Pregnant or intend to become pregnant in the next 9 weeks, - Medical or psychiatric situation that hinders the ability to perform physical activity - None one of the following cardiovascular risk behaviors or conditions: smoking, diagnosed prediabetes/type 2 diabetes, prehypertension/hypertension, high cholesterol, or metabolic syndrome - Not fluent in English, - No access to a personal mobile device

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Project WHADE: A Partner-Based Physical Activity Program for Women
Combination of behavioral, cognitive, social, and acceptance-based skills training to increase physical activity

Locations
Country Name City State
United States Rowan University Glassboro New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Rowan University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of partner communication How frequently each partner dyad communicates with each other between coaching sessions, assessed via self-report in end of day survey (measure created for this study) up to 8 weeks
Primary Satisfaction with partner communication How satisfied each participant is with their partner communication between coaching sessions, assessed via self-report in end of day survey (measure created for this study) up to 8 weeks
Secondary Physical activity behavior - steps Steps per day, assessed with an activity monitor (pedometer with accelerometer) up to 8 weeks
Secondary Physical activity behavior - active minutes Minutes of moderate to vigorous activity per day, assessed with an activity monitor (pedometer with accelerometer) up to 8 weeks
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