Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03684070 |
| Other study ID # |
19.001.01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 18, 2019 |
| Est. completion date |
October 30, 2019 |
Study information
| Verified date |
March 2022 |
| Source |
Boston College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The benefits of physical activity (PA) for healthy aging are well known; however < 16% of
U.S. older adults meet the federal recommendations for moderate to vigorous PA (MVPA). Asian
Americans (AA) are a fast-growing segment of the older adult U.S. population and are likely
to have limited English proficiency, lower-incomes, and low PA levels. Older AA adults are
under represented in clinical trials and as a result, evidence-based PA programs remain
inaccessible. Similarly, while the number of PA interventions for older adults incorporating
technology to promote and sustain behavior change is increasing, the applicability and
efficacy of these approaches for AA is poorly understood. Thus, there is a critical need to
develop and test innovative PA interventions for this at-risk group.
The primary objective of this study is to evaluate if a culturally and linguistically adapted
community-based walking program enhanced with a cognitive behavioral intervention delivered
via WeChat - a widely used Chinese social networking application - (enhanced walking)
improves physical activity compared with walking only. Secondary objectives are to identify
participant experiences in engaging in this platform to improve PA, and gain insights into
the scalability of the intervention for future pivotal trials. The proposed research is a
randomized, controlled trial that will recruit 60 community-dwelling Chinese older adults.
The primary outcomes are PA (measured by FitBit step counts over time, and proportion meeting
federal recommendations for moderate physical activity (MPA)). Secondary outcomes include
patient-reported outcomes, and patient-reported experience measures. We aim to evaluate the
acceptability of this enhanced program, and determine the feasibility of WeChat as a platform
for increasing PA. The primary outcome will be analyzed using mixed effects ANOVA, and latent
growth curve modeling. Secondary outcomes will be analyzed using linear regression.
Semi-structured interviews will be conducted with participants upon program completion to
identify contextual factors influencing application use, and thematic analysis will be used
to examine relationships between these key factors.
Results from this study will provide information about the applicability of mobile technology
in supporting PA improvement among older Chinese, and valuable insight on contextual factors
influencing application effectiveness, which will inform the potential for adoption and
scale.
Description:
Implementation will be conducted at a single site, the Chinese Consolidated Benevolent
Association of New England (CCA)). All subjects will consent to participate prior to
continuing with study involvement as documented below.
Recruitment and Consent:
A convenience sample of a maximum of 60 participants (30 people per arm) will be recruited by
placing ads in local newspapers, flyers at CBOs, local businesses, WeChat, and word of mouth.
Interested individuals will call a dedicated voicemail box at Boston College and leave their
contact information. A trained, bilingual member of the research team will contact interested
individuals to obtain verbal consent for administration of the preliminary screening tool. If
preliminary inclusion criteria are met, participants will be invited to an in-person
secondary screening, where if deemed eligible to participate, signed informed consent for
overall study participation will be obtained by a trained member of the study team in the
participants' preferred language of communication (Mandarin or English). A $50 gift card will
be offered to all enrolled participants.
Study methods:
Participation: After the consenting and initial (baseline) survey administration, assignment
to the experimental or control group will be determined using a randomization list generated
by a random number generator in R software. Both groups will meet on separate days and times
to avoid contamination effects.
All participants will attend an orientation session to provide hands-on training on using the
FitBit, and social networking platform (SNS) (as applicable).
A 2-week tech calibration period with one-on-one training with study staff will allow
participants to acclimate to the FitBit, learn to use its features, and ask questions.
Baseline FitBit data will be collected and monitored via Fitabase (a widely used and secure,
research data management platform specific to FitBit data). This baseline data will allow the
PI to generate an individualized walking prescription.
After this instructional trial period, all participants will be instructed to use the
step-tracker's features to monitor their daily steps and progress towards meeting their
individualized walking goals. All participants will attend 8 weekly educational sessions at
the community center. Each day, those in the Enhanced Walking condition will receive 1-3
motivational messages related to physical activity and health; a monitoring protocol and
database to document SNS interactions will be established. The Walking Only condition will
not receive motivational messages through the SNS platform.
Surveys will be administered at study completion (8 weeks) and follow-up (12 weeks). FitBit
data will be continually monitored throughout the study duration. A weekly adverse
questionnaire will be administered by study staff in-person or via telephone when
appropriate.
Follow-up outcomes: At the end of the study, participants from the experimental arm will be
asked to attend a post-participation session where they will participate in a semi-structured
interview to glean their experiences in using the SNS platform to promote physical activity.
Semi-structured interview questions will be posed to all clients who volunteer to participate
in an interview session as part of the study. The interviews will be held at 4 weeks after
the end of the study period. Interview questions and prompts were developed through a
phenomenological lens to allow clients to elicit their own responses and experiences in the
study. The interview guide will frame this discussion, and participant responses may be
probed to gain further clarity or insight. The interviews will be audio recorded by study
staff. Study staff will also write field notes to document client responses and other
observations to supplement and provide context for the transcripts.
