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Physical ActivityNCT03684070

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

A study testing Self-Monitoring, peer support and motivational prompts and Self-monitoring in people with Physical Activity and Sedentary Lifestyle, run by Boston College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity, Sedentary Lifestyle
What is being tested?
Self-Monitoring, peer support and motivational prompts and Self-monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
18 May 2019to 30 Oct 2019
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • + cognitive impairment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston College

    Chestnut Hill, Massachusetts, 02467

Other trials in United States

About this study

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.

Read the 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.

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.

Being tested
Self-Monitoring, peer support and motivational prompts, Self-monitoring
Keywords
Older adults, Asian Americans, Chinese, behavior change
Medical subject headings
Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Monitoring, peer support and motivational promptsBehavioural

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

  • Self-monitoringBehavioural

    Self-monitoring of data from wearable step count tracker

Study groups in NCT03684070
Study groupRoleWhat they receive
Enhanced WalkingExperimentalFitBit + Lifestyle counseling/education session(8 weeks) + WeChat motivational messages and peer interaction
Receives: Behavioral: Self-Monitoring, peer support and motivational prompts
Walking OnlyActive comparatorFitBit + Lifestyle counseling/education session(8 weeks)
Receives: Behavioral: Self-monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity

    Step counts as measured through FitBit tracker

    Measured: Through study completion, and average of 12 weeks

Secondary outcomes (2)
  1. Self-efficacy for physical activity

    Self-Efficacy for Exercise (Resnick \& Jenkins, 2000)

    Measured: Through study completion, and average of 12 weeks

  2. Qualitative Feedback

    Semi-structured interviews

    Measured: 4 weeks post-study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2018
  2. Study start18 May 2019
  3. Primary completion10 Sep 2019
  4. Study completion30 Oct 2019

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03684070
Sponsor's protocol ID
19.001.01
Status last verified
Mar 2022
First submitted
24 Sep 2018
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All collected de-identified IPD will be shared within research consortium, but will not be available to external researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Self-Monitoring, peer support and motivational prompts and Self-monitoring in people with Physical Activity and Sedentary Lifestyle, run by Boston College at 1 site in United States.

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 5 inclusion and 1 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: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Physical Activity (time frame: Through study completion, and average of 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Mar 2022.

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