- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05906290
Formative Development of a Multigenerational eHealth Intervention for Grandparents and Grandchildren
June 6, 2023 updated by: Sara StGeorge, University of Miami
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
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
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
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: Multigenerational eHealth Intervention for Grandparents and Grandchildren Group
Participants in this group will have access to eHealth intervention for 2 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara M St. George, PhD, University of Miami
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.
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)
May 16, 2018
Primary Completion (Actual)
February 5, 2019
Study Completion (Actual)
December 18, 2020
Study Registration Dates
First Submitted
June 6, 2023
First Submitted That Met QC Criteria
June 6, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 20171095
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Physical Inactivity
-
Bess MarcusNational Heart, Lung, and Blood Institute (NHLBI); Lifespan/ The Miriam HospitalRecruitingInactivity | Inactivity, Physical | Inactivity/Low Levels of ExerciseUnited States
-
Chinese University of Hong KongNot yet recruitingPhysical InactivityHong Kong
-
Brown UniversityNational Cancer Institute (NCI)Recruiting
-
University of Milano BicoccaFederico II University; University of BergamoRecruitingPhysical InactivityItaly
-
University of CalgaryPublic Health Agency of Canada (PHAC)Recruiting
-
University of MinnesotaCompletedPhysical InactivityUnited States
-
Universiti Putra MalaysiaCompletedInactivity, PhysicalPakistan
-
Ludwig Boltzmann Institute for Digital Health and...CompletedPhysical InactivityAustria
-
Brown UniversityNational Institute of General Medical Sciences (NIGMS)CompletedPhysical InactivityUnited States
-
Clemson UniversityPrisma Health-Upstate; YMCACompleted
Clinical Trials on Multigenerational eHealth Intervention for Grandparents and Grandchildren
-
CEU San Pablo UniversityRecruitingQuality of Life | Psychological Well-being | Skill, Coping | VirtuesSpain
-
Jinan University GuangzhouGuangzhou Sport UniversityCompletedObesity Prevention | Depression - Major Depressive Disorder | Psychological Well BeingChina
-
University of TorontoCompletedCovid19Canada, India, Thailand
-
ISPA - Instituto Universitario de Ciencias Psicologicas...Fundação para a Ciência e a TecnologiaActive, not recruitingUrinary IncontinencePortugal
-
Göteborg UniversityThe Swedish Research CouncilRecruiting
-
iOMEDICO AGRoche Pharma AGCompletedExtensive-stage Small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Advanced (Locally Advanced and Inoperable or Metastatic), PD-L1 IC-positive TNBCGermany
-
Luxembourg Institute of HealthCentre Hospitalier du Luxembourg; Centre Hospitalier Emile MayrischCompletedBreast CancerLuxembourg
-
Texas Tech UniversityCompleted
-
Vastra Gotaland RegionGöteborg UniversityRecruiting
-
Duke UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedOsteoarthritisUnited States