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

April 1, 2025 updated by: Rowan University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Glassboro, New Jersey, United States, 08028
        • Rowan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Project WHADE: A Partner-Based Physical Activity Program for Women
Behavioral and cognitive skills to promote physical activity behavior
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of partner communication
Time Frame: up to 8 weeks
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
Satisfaction with partner communication
Time Frame: up to 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity behavior - steps
Time Frame: up to 8 weeks
Steps per day, assessed with an activity monitor (pedometer with accelerometer)
up to 8 weeks
Physical activity behavior - active minutes
Time Frame: up to 8 weeks
Minutes of moderate to vigorous activity per day, assessed with an activity monitor (pedometer with accelerometer)
up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rowan University

Investigators

  • Principal Investigator: Danielle Arigo, Ph.D., Rowan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-2023-355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol and analysis plan will be available via Open Science Framework (osf.io).

IPD Sharing Time Frame

To be posted by 6/1 and accessible indefinitely.

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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