NCT06523946

Brief Summary

This proposed longitudinal study will examine the influences of neighborhood factors and momentary contextual and psychosocial factors, which the investigators call acute precipitants, on physical activity (PA) adoption and maintenance among Pacific Islanders (PcIs). Specifically, the investigators will enroll 150 sedentary PcI adults and examine their PA adoption and maintenance based on measurements at five separate weeks during a 20-month period. The investigators will use MotionSense, an innovative and proven mHealth kit developed by team members, Global Positioning System (GPS), and ecological momentary assessment to measure PA and its key determinants. Our central hypotheses are that individual and neighborhood factors are associated with PA adoption and maintenance among previously sedentary PcIs, and that psychosocial precipitants mediate these associations.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress39%
May 2025Jun 2028

First Submitted

Initial submission to the registry

July 12, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

May 19, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

July 12, 2024

Last Update Submit

July 31, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Physical activity adoption measure 1

    Physical activity adoption will be defined in terms of change of weekly moderate-to-vigorous physical activity (MVPA) minutes during the 5 measurement weeks.

    5 separate weeks' data in 20 months for each participant

  • Physical activity maintenance measure 1

    Physical activity maintenance will be defined in terms of change of weekly moderate-to-vigorous physical activity (MVPA) minutes during the 5 measurement weeks.

    5 separate weeks' data in 20 months for each participant

  • Physical activity adoption measure 2

    Physical activity adoption will also be measured by a binary variable-i.e., whether the participant meets the weekly PA threshold or not.

    5 separate weeks' data in 20 months for each participant

  • Physical activity maintenance measure 2

    A secondary type of physical activity maintenance would be a binary variable-i.e., whether the participant meets the weekly PA threshold or not

    5 separate weeks' data in 20 months for each participant

Study Arms (1)

Pacific Islander (PcI) Adults

The investigators will enroll 150 sedentary Pacific Islander (PcI) adults. The investigators will first use an evidence-based physical activity (PA) program tool on all participants to stimulate their PA levels, and then study how contextual and psychosocial factors influence PA initiation and maintenance. The investigators will assess participants for 5 separate weeks during a 20-month span using real-time, field-based, state-of-the-art methodologies consisting of MotionSense (a well-validated on-body mobile sensor system), ecological momentary assessment (EMA), and the Global Positioning System (GPS).

Behavioral: Diabetes Prevention Program (DPP) (shortened)

Interventions

The investigators will adapt the protocol of the 'Ohana project. The 'Ohana protocol was developed based on CDC's Diabetes Prevention Program (DPP) curriculum and designed to fit PcI's cultural background. It includes a 8-lesson curriculum delivered in 8 weeks (shortened from the original 16-lesson, 24-week core curriculum of DPP while retaining all original foci and behavior change strategies). Specifically, the first four lessons, delivered every week, focus on getting the participants started on increasing PA and improving diet (e.g., introduction; getting started on PA and diet; utilizing goal setting; making the process fun). The second four classes will be taught every other week and will focus on how to handle various challenges involved in maintaining healthy lifestyle behaviors. The investigators will deliver the curriculum in group settings of 15 people in a separate room in the National Tongan American Society.

Pacific Islander (PcI) Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This longitudinal cohort study will enroll 150 sedentary Tongan American (TA) adults (equally split between male and female) in Utah. Utah has the highest per-capita percentage of PcIs among the continental states, with a PcI population of 38,000 in 2014. TAs are the largest PcI group in Utah, accounting for 38% of the total PcI population. TAs primarily live in urban areas of Salt Lake and Utah counties, the two most populous counties in the state. The gender ratio is approximately 1 (i.e., 102 males to 100 females). About 7% of TAs hold a bachelor's degree, the lowest rate among all racial/ethnic groups. Although the majority live in relatively low income neighborhoods, over a quarter live in census tracts with poverty rate \<5% (average median household income: $92,301), suggesting good heterogeneity in their socioeconomic status. About 27% of the TA population in Utah were foreign-born.

You may qualify if:

  • age 18 years of age or older (because children and adolescents are different from adults in terms of PA level, PA mechanisms, psychosocial factors, and measurement accuracy);
  • being Tongan American (TA); being currently sedentary which is defined as self-reported PA less than 3 days/week for less than 20 minutes/day over the last 6 month;
  • no underlying functional impairment;
  • valid home address;
  • functioning telephone number;
  • can speak, read, and write in English;
  • marginal or adequate health literacy.

You may not qualify if:

  • currently in a physical activity program or participated in a physical activity program in the past year;
  • have a pacemaker or implanted cardiac device;
  • have any dietary/exercise restrictions or limitations, and/or co-morbid conditions that would have precluded them from fully participating in the study;
  • physically unable to wear equipment and provide a good reading or use a smartphone;
  • pregnancy or lactation;
  • with active diagnoses of major depression, cognitive impairment (of any etiology), or any functional impairment; or any uncontrolled medical or psychiatric problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

dentin sialophosphoprotein

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Neng Wan, Ph.D.

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 29, 2024

Study Start

May 19, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

August 3, 2026

Record last verified: 2026-07

Locations