Physical ActivityNCT04073355
Smart Walk 50+: Feasibility of a Smartphone-delivered Physical Activity Program for African American Women 50 Years and Older
A study testing Physical Activity in people with Physical Activity, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2019to 30 Jun 2020
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported African American female
- Between the ages of 50 to 65
- Insufficiently Active (less than or equal to 60 mins of moderate-to-vigorous physical activity/week measured by Exercise Vital Sign Questionnaire)
- BMI > 30
- English speaking and reading
Who cannot join
- Plans to relocate out of Phoenix area in next 6 months
- Endorsing an item on the PAR-Q, unless a doctor's note for study participation in provided
- Self-reported participation in another diet or weight loss study
- Non-English reading and speaking
- Pregnant or planning to become pregnant in the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years.
Read the detailed description
This study will establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years. To accomplish this, we will deliver our previously developed Smart Walk physical activity intervention, originally developed for African American women aged 24-50 years old, to 20 sedentary and obese African American women aged 50 to 65. We will collect data on the acceptability and feasibility of the intervention, as well as areas of intervention refinement to enhance the social, cultural, and behavioral relevance of the intervention for women in this age group.
- Conditions
- Physical Activity
- Being tested
- Physical Activity
- Keywords
- exercise, African American women, mHealth, eHealth, smartphone
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Smartphone-delivered physical activity intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Smartphone-delivered physical activity intervention Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and Feasibility: Treatment Acceptance
Treatment acceptance will be assessed via a post-intervention treatment acceptance survey and qualitative data from a post-intervention focus group.
Measured: 4 months
Acceptability and Feasibility: Number of participants who complete 4-month follow-up assessments
Number of participants who complete 4-month follow-up assessment
Measured: 4 months
Secondary outcomes (7)
Changes in Objectively-measured Physical Activity
Pre-post intervention changes in physical activity measured by accelerometers
Measured: 4 months
Changes in self-reported Physical Activity
Pre-post intervention changes in self-reported physical activity as measured by the REGICOR questionnaire
Measured: 4 months
Changes in Exercise Self-efficacy
Pre-post intervention changes in exercise self-efficacy. Assessed by the Exercise Confidence Survey (Sallis, 1988).
Measured: 4-months
Changes in Outcome Expectations for Exercise
Pre-post intervention changes in outcome expectations for exercise; assessed by the Outcome Expectation Scale for Exercise (Resnick, 2000
Measured: 4-months
Changes in Physical Activity Self-regulation
Pre-post intervention changes in self-regulation for physical activity; assessed by the Self-Regulation Scale from the Health Beliefs Survey (Anderson, 2010)
Measured: 4-months
Changes in Social Support for Exercise
Pre-post intervention changes in social support for exercise; assessed by the Social Support for Exercise Survey (Sallis,1987)
Measured: 4-months
Changes in Physical Activity Knowledge
Pre-post intervention changes in knowledge of the national physical activity guidelines; assessed by a 6 item scale developed by study authors
Measured: 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start10 Aug 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodney P Joseph, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073355
- Sponsor's protocol ID
- STUDY00010333
- Status last verified
- Jul 2020
- First submitted
- 26 Aug 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joseph RP, Ainsworth BE, Hollingshead K, Todd M, Keller C. Results of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention Among Midlife African American Women: Feasibility Trial. JMIR Mhealth Uhealth. 2021 Apr 22;9(4):e27383. doi: 10.2196/27383.
PubMed 33885368
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Walk 50+: Feasibility of a Smartphone-delivered Physical Activity Program for African American Women 50 Years and Older
- ClinicalTrials.gov ID
- NCT04073355
- Acronym / sponsor ID
- STUDY00010333
- Conditions
- Physical Activity
- Keywords
- exercise, African American women, mHealth, eHealth, smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Aug 2019 (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.
The purpose of this study is to establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years.
Detailed description
This study will establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years. To accomplish this, we will deliver our previously developed Smart Walk physical activity intervention, originally developed for African American women aged 24-50 years old, to 20 sedentary and obese African American women aged 50 to 65. We will collect data on the acceptability and feasibility of the intervention, as well as areas of intervention refinement to enhance the social, cultural, and behavioral relevance of the intervention for women in this age group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical ActivitySmartphone-delivered physical activity intervention |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported African American female
- Between the ages of 50 to 65
- Insufficiently Active (less than or equal to 60 mins of moderate-to-vigorous physical activity/week measured by Exercise Vital Sign Questionnaire)
- BMI > 30
- English speaking and reading
Key exclusion criteria (5 listed)
- Plans to relocate out of Phoenix area in next 6 months
- Endorsing an item on the PAR-Q, unless a doctor's note for study participation in provided
- Self-reported participation in another diet or weight loss study
- Non-English reading and speaking
- Pregnant or planning to become pregnant in the next 6 months
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 |
|---|---|---|
| Physical ActivitySmartphone-delivered physical activity intervention | Behavioural | Physical Activity |
Primary outcome
Acceptability and Feasibility: Treatment Acceptance
Time frame: 4 months
Treatment acceptance will be assessed via a post-intervention treatment acceptance survey and qualitative data from a post-intervention focus group.
Acceptability and Feasibility: Number of participants who complete 4-month follow-up assessments
Time frame: 4 months
Number of participants who complete 4-month follow-up assessment
7 secondary outcomes
Changes in Objectively-measured Physical Activity
Time frame: 4 months
Changes in self-reported Physical Activity
Time frame: 4 months
Changes in Exercise Self-efficacy
Time frame: 4-months
Changes in Outcome Expectations for Exercise
Time frame: 4-months
Changes in Physical Activity Self-regulation
Time frame: 4-months
Changes in Social Support for Exercise
Time frame: 4-months
Changes in Physical Activity Knowledge
Time frame: 4-months
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 8 Jul 2020.
- Derived from this study: PubMed 33885368Joseph RP, Ainsworth BE, Hollingshead K, Todd M, Keller C. Results of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention Among Midlife African American Women: Feasibility Trial. JMIR Mhealth Uhealth. 2021 Apr 22;9(4):e27383. doi: 10.2196/27383.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Physical Activity, run by Arizona State 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 5 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 8 Jul 2020. 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?
Acceptability and Feasibility: Treatment Acceptance (time frame: 4 months). 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 NCT04073355, which also lists 1 linked publication.
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 8 Jul 2020.