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

10. marts 2022 opdateret af: Carina Katigbak, Boston College

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Massachusetts
      • Chestnut Hill, Massachusetts, Forenede Stater, 02467
        • Boston College

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Enhanced Walking
FitBit + Lifestyle counseling/education session(8 weeks) + WeChat motivational messages and peer interaction
The intervention compares the effect of technologically delivered motivational messages, and peer support upon daily step counts.
Aktiv komparator: Walking Only
FitBit + Lifestyle counseling/education session(8 weeks)
Self-monitoring of data from wearable step count tracker

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical Activity
Tidsramme: Through study completion, and average of 12 weeks
Step counts as measured through FitBit tracker
Through study completion, and average of 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Self-efficacy for physical activity
Tidsramme: Through study completion, and average of 12 weeks
Self-Efficacy for Exercise (Resnick & Jenkins, 2000)
Through study completion, and average of 12 weeks
Qualitative Feedback
Tidsramme: 4 weeks post-study completion
Semi-structured interviews
4 weeks post-study completion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Carina Katigbak, PhD, Boston College

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. maj 2019

Primær færdiggørelse (Faktiske)

10. september 2019

Studieafslutning (Faktiske)

30. oktober 2019

Datoer for studieregistrering

Først indsendt

24. september 2018

Først indsendt, der opfyldte QC-kriterier

24. september 2018

Først opslået (Faktiske)

25. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 19.001.01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fysisk aktivitet

Kliniske forsøg med Self-Monitoring, peer support and motivational prompts

Abonner