HypertensionNCT06350604
Project WHADE: A Partner-Based Physical Activity Program for Women
A study testing Project WHADE: A Partner-Based Physical Activity Program for Women in people with Hypertension and Type 2 Diabetes, run by Rowan University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Hypertension, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- Project WHADE: A Partner-Based Physical Activity Program for Women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Hypertension, Type 2 Diabetes, Metabolic Syndrome, Smoking, High Cholesterol, PreDiabetes
- Being tested
- Project WHADE: A Partner-Based Physical Activity Program for Women
- Keywords
- Social support, Physical activity
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Metabolic Syndrome, Smoking, Hypercholesterolemia, Prediabetic State, Prehypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project WHADE: A Partner-Based Physical Activity Program for WomenBehavioural
Combination of behavioral, cognitive, social, and acceptance-based skills training to increase physical activity
| Study group | Role | What they receive |
|---|---|---|
| Project WHADE: A Partner-Based Physical Activity Program for Women | Experimental | Behavioral and cognitive skills to promote physical activity behavior Receives: Behavioral: Project WHADE: A Partner-Based Physical Activity Program for Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: up to 8 weeks
Secondary outcomes (2)
Physical activity behavior - steps
Steps per day, assessed with an activity monitor (pedometer with accelerometer)
Measured: up to 8 weeks
Physical activity behavior - active minutes
Minutes of moderate to vigorous activity per day, assessed with an activity monitor (pedometer with accelerometer)
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start2 Jan 2024
- Primary completion15 Jul 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Arigo, Ph.D., Principal investigator, Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350604
- Sponsor's protocol ID
- PRO-2023-355
- Status last verified
- Nov 2024
- First submitted
- 15 Mar 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and analysis plan will be available via Open Science Framework (osf.io).
Publications
Benasi G, Salvatore GM, Mehta S, Rivera AR, Folk AL, Arigo D. Self-selected exercise goals during a broader physical activity intervention for women in midlife with elevated risk for cardiovascular disease: A mixed methods evaluation. Psychol Sport Exerc. 2026 Jul;85:103152. doi: 10.1016/j.psychsport.2026.103152. Epub 2026 May 6.
PubMed 42102943Arigo 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. 2026 Apr;45(4):413-422. doi: 10.1037/hea0001554. Epub 2025 Sep 29.
PubMed 41021523
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project WHADE: A Partner-Based Physical Activity Program for Women
- ClinicalTrials.gov ID
- NCT06350604
- Acronym / sponsor ID
- PRO-2023-355
- Conditions
- Hypertension, Type 2 Diabetes, Metabolic Syndrome, Smoking, High Cholesterol, PreDiabetes
- Keywords
- Social support, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| Project WHADE: A Partner-Based Physical Activity Program for Women | Experimental | Behavioral: Project WHADE: A Partner-Based Physical Activity Program for WomenBehavioral and cognitive skills to promote physical activity behavior |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project WHADE: A Partner-Based Physical Activity Program for WomenCombination of behavioral, cognitive, social, and acceptance-based skills training to increase physical activity | Behavioural | Project WHADE: A Partner-Based Physical Activity Program for Women |
Primary outcome
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)
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)
2 secondary outcomes
Physical activity behavior - steps
Time frame: up to 8 weeks
Physical activity behavior - active minutes
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 42102943Benasi G, Salvatore GM, Mehta S, Rivera AR, Folk AL, Arigo D. Self-selected exercise goals during a broader physical activity intervention for women in midlife with elevated risk for cardiovascular disease: A mixed methods evaluation. Psychol Sport Exerc. 2026 Jul;85:103152. doi: 10.1016/j.psychsport.2026.103152. Epub 2026 May 6.
- Derived from this study: PubMed 41021523Arigo 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. 2026 Apr;45(4):413-422. doi: 10.1037/hea0001554. Epub 2025 Sep 29.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Protocol and analysis plan will be available via Open Science Framework (osf.io).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Arigo, Ph.D. principal investigator
Rowan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project WHADE: A Partner-Based Physical Activity Program for Women in people with Hypertension and Type 2 Diabetes, run by Rowan University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of partner communication (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06350604, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.