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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• High Cholesterol
• Hypercholesterolemia
• Hypertension
• Metabolic Syndrome
• PreDiabetes
• Prehypertension
• Smoking
• Type 2 Diabetes

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

External Links

•   Project website