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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Physical Activity, Sedentary Lifestyle
- 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 group | Role | What they receive |
|---|---|---|
| Enhanced Walking | Experimental | FitBit + Lifestyle counseling/education session(8 weeks) + WeChat motivational messages and peer interaction Receives: Behavioral: Self-Monitoring, peer support and motivational prompts |
| Walking Only | Active comparator | FitBit + 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.
Physical Activity
Step counts as measured through FitBit tracker
Measured: Through study completion, and average of 12 weeks
Secondary outcomes (2)
Self-efficacy for physical activity
Self-Efficacy for Exercise (Resnick \& Jenkins, 2000)
Measured: Through study completion, and average of 12 weeks
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.
- First posted25 Sep 2018
- Study start18 May 2019
- Primary completion10 Sep 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- Brandeis University, Northeastern University
- Responsible party
- Principal investigator, Carina Katigbak, Boston College
- Investigators
- Carina Katigbak, PhD, Principal investigator, Boston College
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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Together we Move: A Multi-component Intervention to Increase Physical Activity for Ethnic Minority Older Adults
- ClinicalTrials.gov ID
- NCT03684070
- Acronym / sponsor ID
- 19.001.01
- Conditions
- Physical Activity, Sedentary Lifestyle
- Keywords
- Older adults, Asian Americans, Chinese, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Brandeis University, Northeastern University
- Study start
- 18 May 2019 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Walking | Experimental | Behavioral: Self-Monitoring, peer support and motivational promptsFitBit + Lifestyle counseling/education session(8 weeks) + WeChat motivational messages and peer interaction |
| Walking Only | Active comparator | Behavioral: Self-monitoringFitBit + Lifestyle counseling/education session(8 weeks) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- + cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Monitoring, peer support and motivational promptsThe intervention compares the effect of technologically delivered motivational messages, and peer support upon daily step counts. | Behavioural | Enhanced Walking |
| Self-monitoringSelf-monitoring of data from wearable step count tracker | Behavioural | Walking Only |
Primary outcome
Physical Activity
Time frame: Through study completion, and average of 12 weeks
Step counts as measured through FitBit tracker
2 secondary outcomes
Self-efficacy for physical activity
Time frame: Through study completion, and average of 12 weeks
Qualitative Feedback
Time frame: 4 weeks post-study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No. All collected de-identified IPD will be shared within research consortium, but will not be available to external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina Katigbak, PhD principal investigator
Boston College
1 site in 1 country: see every site and its status.
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.