NCT04445168

Brief Summary

Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
451

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

5.3 years

First QC Date

June 16, 2020

Last Update Submit

March 19, 2025

Conditions

PreDiabetesDiabetesSedentary Behavior

Keywords

Physical activityRandomized trialPrimary care

Outcome Measures

Primary Outcomes (2)

  • Moderate to vigorous physical activity (MVPA)

    Accelerometer-derived 7-day MVPA

    12 months

  • Moderate to vigorous physical activity (MVPA)

    Accelerometer-derived 7-day MVPA

    24 months

Secondary Outcomes (10)

  • Weight

    12 months

  • Weight

    24 months

  • Systolic blood pressure

    12 months

  • Systolic blood pressure

    24 months

  • Diastolic blood pressure

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics.

Intervention

EXPERIMENTAL

Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.

Behavioral: Telephone-based motivational interviews

Interventions

Telephone-based motivational interviewsBEHAVIORAL

2-year telephone-based motivational interviews to increase physical activity.

Intervention

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least 12 months, Receives primary care at the Fontana Medical Center, Body mass index between 18.5 and 40 kg/m2,

You may not qualify if:

  • Current use of insulin, Cardiovascular event in the past 6 months or other condition that limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years, Current participation in another clinical trial or research study, Plans to move out of the area in next 2 years,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 911010, United States

Location

MeSH Terms

Conditions

Prediabetic StateDiabetes MellitusSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 24, 2020

Study Start

August 31, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)