Physical InactivityNCT05906290
Formative Development of a Multigenerational eHealth Intervention for Grandparents and Grandchildren
A study testing Multigenerational eHealth Intervention for Grandparents and Grandchildren in people with Physical Inactivity, run by University of Miami.
Trial summary
This study develops a multigenerational electronic Health (eHealth) (web and mobile phone-based) program to improve physical activity levels and to better understand the relationship between grandparents and their grandchildren. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Multigenerational eHealth Intervention for Grandparents and Grandchildren
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2018to 18 Dec 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or male grandparent with a grandchild
- Grandparent is at least 45 years old
- Grandparent has a grandchild between the ages of 6-12 years old
- Grandparent is English or Spanish speaking
Who cannot join
- Grandparent has a chronic medical condition that interferes with physical activity (e.g., wheelchair bound, severe heart disease, uncontrolled hypertension, brittle diabetes mellitus, chronic arthritis)
- Grandparent has a diagnosis of dementia or significant cognitive impairment based on the telephone interview for cognitive status (TICS)
About this study
This study develops a multigenerational electronic Health (eHealth) (web and mobile phone-based) program to improve physical activity levels and to better understand the relationship between grandparents and their grandchildren. The importance of social and familial support for older adults and the need to address increasing declines in physical activity for both children and older adults. Health promotion interventions that capitalize on the existing relationship between grandparents and grandchildren may simultaneously improve health-related outcomes for older adults and children.
- Conditions
- Physical Inactivity
- Being tested
- Multigenerational eHealth Intervention for Grandparents and Grandchildren
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multigenerational eHealth Intervention for Grandparents and GrandchildrenOther
Participants in this group will use an online program for 30-45 minutes per week over the course of 2 weeks delivered via smartphone, focusing on increasing physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Multigenerational eHealth Intervention for Grandparents and Grandchildren Group | Experimental | Participants in this group will have access to eHealth intervention for 2 weeks. Receives: Other: Multigenerational eHealth Intervention for Grandparents and Grandchildren |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program acceptability as measured by Qualitative Interview Guide Field Trial
Program acceptability will be measured by Qualitative Interview Guide Field Trial. Participants indicate whether they like the program in a qualitative exit interview. The interview guide consists of 13 open-ended questions regarding the participant's experience testing the program. Acceptability will be based on emergent themes.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start16 May 2018
- Primary completion5 Feb 2019
- Study completion18 Dec 2020
Why it stopped: Study Stopped Early Due to COVID Restrictions
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 InactivityStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Center on Aging and Adult Development Disabilities (CADD)
- Responsible party
- Principal investigator, Sara StGeorge, University of Miami
- Investigators
- Sara M St. George, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906290
- Sponsor's protocol ID
- 20171095
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kobayashi MA, St George SM, Leite RO, Noriega Esquives B, Wetstone R, Pulgaron ER, Prado G, Czaja SJ. Formative Development of a Technology-Based Physical Activity Intervention for Grandparents and Grandchildren. J Aging Phys Act. 2022 Jun 1;30(3):482-494. doi: 10.1123/japa.2020-0481. Epub 2021 Oct 5.
PubMed 34611054
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Development of a Multigenerational eHealth Intervention for Grandparents and Grandchildren
- ClinicalTrials.gov ID
- NCT05906290
- Acronym / sponsor ID
- 20171095
- Conditions
- Physical Inactivity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Stopped Early Due to COVID Restrictions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Center on Aging and Adult Development Disabilities (CADD)
- Study start
- 16 May 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 15 Jun 2023 (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 develops a multigenerational electronic Health (eHealth) (web and mobile phone-based) program to improve physical activity levels and to better understand the relationship between grandparents and their grandchildren. The importance of social and familial support for older adults and the need to address increasing declines in physical activity for both children and older adults. Health promotion interventions that capitalize on the existing relationship between grandparents and grandchildren may simultaneously improve health-related outcomes for older adults and children.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multigenerational eHealth Intervention for Grandparents and Grandchildren Group | Experimental | Other: Multigenerational eHealth Intervention for Grandparents and GrandchildrenParticipants in this group will have access to eHealth intervention for 2 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male grandparent with a grandchild
- Grandparent is at least 45 years old
- Grandparent has a grandchild between the ages of 6-12 years old
- Grandparent is English or Spanish speaking
Key exclusion criteria (2 listed)
- Grandparent has a chronic medical condition that interferes with physical activity (e.g., wheelchair bound, severe heart disease, uncontrolled hypertension, brittle diabetes mellitus, chronic arthritis)
- Grandparent has a diagnosis of dementia or significant cognitive impairment based on the telephone interview for cognitive status (TICS)
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 |
|---|---|---|
| Multigenerational eHealth Intervention for Grandparents and GrandchildrenParticipants in this group will use an online program for 30-45 minutes per week over the course of 2 weeks delivered via smartphone, focusing on increasing physical activity. | Other | Multigenerational eHealth Intervention for Grandparents and Grandchildren Group |
Primary outcome
Program acceptability as measured by Qualitative Interview Guide Field Trial
Time frame: 2 weeks
Program acceptability will be measured by Qualitative Interview Guide Field Trial. Participants indicate whether they like the program in a qualitative exit interview. The interview guide consists of 13 open-ended questions regarding the participant's experience testing the program. Acceptability will be based on emergent themes.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 34611054Kobayashi MA, St George SM, Leite RO, Noriega Esquives B, Wetstone R, Pulgaron ER, Prado G, Czaja SJ. Formative Development of a Technology-Based Physical Activity Intervention for Grandparents and Grandchildren. J Aging Phys Act. 2022 Jun 1;30(3):482-494. doi: 10.1123/japa.2020-0481. Epub 2021 Oct 5.
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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.
Sara M St. George, PhD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A study testing Multigenerational eHealth Intervention for Grandparents and Grandchildren in people with Physical Inactivity, run by University of Miami.
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 2 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: withdrawn, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Program acceptability as measured by Qualitative Interview Guide Field Trial (time frame: 2 weeks). 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 NCT05906290, 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 15 Jun 2023.