NCT06350604

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

April 4, 2025

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

March 15, 2024

Last Update Submit

April 1, 2025

Conditions

HypertensionType 2 DiabetesMetabolic SyndromeSmokingHigh CholesterolPreDiabetesPrehypertension

Keywords

Social supportPhysical activity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Physical activity behavior - steps

    up to 8 weeks

  • Physical activity behavior - active minutes

    up to 8 weeks

Study Arms (1)

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

EXPERIMENTAL

Behavioral and cognitive skills to promote physical activity behavior

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

Interventions

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

Combination of behavioral, cognitive, social, and acceptance-based skills training to increase physical activity

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

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIdentification as a woman
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowan University

Glassboro, New Jersey, 08028, United States

Location

Related Publications (1)

  • Arigo D, Baga K, Folk AL, Haggerty K. Physical activity partners for women with cardiovascular disease risk: Proof-of-concept trial with daily assessment. Health Psychol. 2025 Sep 29:10.1037/hea0001554. doi: 10.1037/hea0001554. Online ahead of print.

    PMID: 41021523DERIVED

Related Links

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2Metabolic SyndromeSmokingHypercholesterolemiaPrediabetic StatePrehypertensionMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismBehaviorHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Danielle Arigo, Ph.D.

    Rowan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants receive the same intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2024

First Posted

April 5, 2024

Study Start

January 2, 2024

Primary Completion

July 15, 2024

Study Completion

November 15, 2024

Last Updated

April 4, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
To be posted by 6/1 and accessible indefinitely.
Access Criteria
Public
More information

Locations

US(1)