NCT05227105

Brief Summary

The purpose of this study is to address physical inactivity in rural populations in Pennsylvania.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
880

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started May 2023

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
May 2023Dec 2027

First Submitted

Initial submission to the registry

January 27, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

January 27, 2022

Last Update Submit

April 18, 2026

Conditions

Overweight or ObesityDiabetes Mellitus, Type 2Physical Inactivity

Outcome Measures

Primary Outcomes (2)

  • Physical Activity Questionnaire

    The 11-question Morgenstern Physical Activity Questionnaire (PAQ-M) is a self-report of physical activity resulting from recreational activities, exercises, home or work activities, and chores.

    12 months vs. baseline

  • Objective accelerometry

    An accelerometer will be worn for one week to track physical activity.

    12 months vs. baseline

Secondary Outcomes (2)

  • Physical Activity Questionnaire

    24 months vs. baseline; 24 months vs. 12 months

  • Objective accelerometry

    24 months vs. baseline; 24 months vs. 12 months

Study Arms (2)

Physical Activity intervention

ACTIVE COMPARATOR

Five physical activity coaching calls with MoveLine and weekly physical activity. Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

Behavioral: Physical Activity

Delayed intervention

PLACEBO COMPARATOR

Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

Behavioral: Delayed intervention

Interventions

Physical ActivityBEHAVIORAL

Physical activity will be encouraged up to an amount of 150 minutes per week.

Physical Activity intervention
Delayed interventionBEHAVIORAL

Physical activity will be encouraged at the end of the trial.

Delayed intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 - 75 at the time of enrollment
  • Either overweight/obese (Body Mass Index (BMI) ≥ 25) or diabetic (hemoglobin A1c ≥ 5.7%)
  • Physically inactive (defined as \< 90 min/week of self-reported structured physical activity)
  • Able to speak, read, and understand the English language
  • Resides in a rural area of Pennsylvania with a Rural Urban Continuum Code (RUCC) 4 - 9 or Rural-Urban Commuting Area (RUCA) code 4 - 10
  • Must be able to provide and understand informed consent
  • Primary care patient of one of the participating providers
  • Self-report ability to walk ¼ mile
  • Access to a telephone

You may not qualify if:

  • Mental impairment leading to inability to cooperate, provide informed consent, or follow study instructions
  • Evidence in the electronic medical record of an absolute contraindication for physical activity
  • Severe or advanced orthopedic conditions
  • Use of assistive devices for ambulation
  • Resides outside of a rural area of Pennsylvania (i.e., one that is not RUCC code 4 - 9 OR RUCA code 4 - 10)
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kathryn Schmitz, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 7, 2022

Study Start

May 23, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)