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Clinical Trials/NCT03684070
NCT03684070CompletedNot Applicable

Together we Move: A Multi-component Intervention to Increase Physical Activity for Ethnic Minority Older Adults

Boston College1 site in 1 country60 target enrollmentStarted: May 18, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Physical Activity

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •self-identify as Chinese/Chinese American
  • •can communicate in Mandarin or English
  • •reside in Boston
  • •smartphone owners (iPhone or Android) with data plan
  • •no falls within last 6 months

Exclusion Criteria

  • •+ cognitive impairment

Arms & Interventions

Enhanced Walking

Experimental

FitBit + Lifestyle counseling/education session(8 weeks) + WeChat motivational messages and peer interaction

Intervention: Self-Monitoring, peer support and motivational prompts (Behavioral)

Walking Only

Active Comparator

FitBit + Lifestyle counseling/education session(8 weeks)

Intervention: Self-monitoring (Behavioral)

Outcomes

Primary Outcomes

Physical Activity

Time Frame: Through study completion, and average of 12 weeks

Step counts as measured through FitBit tracker

Secondary Outcomes

  • Self-efficacy for physical activity(Through study completion, and average of 12 weeks)
  • Qualitative Feedback(4 weeks post-study completion)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carina Katigbak

Assistant Professor

Boston College

Study Sites (1)

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