NCT03684070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

September 24, 2018

Last Update Submit

March 10, 2022

Conditions

Keywords

Older adultsAsian AmericansChinesebehavior change

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    Step counts as measured through FitBit tracker

    Through study completion, and average of 12 weeks

Secondary Outcomes (2)

  • Self-efficacy for physical activity

    Through study completion, and average of 12 weeks

  • Qualitative Feedback

    4 weeks post-study completion

Study Arms (2)

Enhanced Walking

EXPERIMENTAL

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

Behavioral: Self-Monitoring, peer support and motivational prompts

Walking Only

ACTIVE COMPARATOR

FitBit + Lifestyle counseling/education session(8 weeks)

Behavioral: Self-monitoring

Interventions

The intervention compares the effect of technologically delivered motivational messages, and peer support upon daily step counts.

Enhanced Walking
Self-monitoringBEHAVIORAL

Self-monitoring of data from wearable step count tracker

Walking Only

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \+ cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston College

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative Techniques

Study Officials

  • Carina Katigbak, PhD

    Boston College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 25, 2018

Study Start

May 18, 2019

Primary Completion

September 10, 2019

Study Completion

October 30, 2019

Last Updated

March 14, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

All collected de-identified IPD will be shared within research consortium, but will not be available to external researchers.

Locations