Activity Prescription in Clinical Practice

NCT ID: NCT03695016

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2020-03-30

Brief Summary

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Most adults do not achieve the US aerobic physical activity (PA) guidelines (≥150 minutes/week of at least moderate intensity PA). Inadequate PA is considered a major risk factor for cardio-metabolic diseases and other poor health outcomes. Recommendations now endorse PA in reducing risk for certain diseases. Unfortunately, low PA levels are seldom identified and treated within clinical practice. This study will build on previous prevention efforts by focusing on the identifying and treating low PA levels in adults clinical care patients and referring them to an intervention that is feasible for delivery through clinical care.

Detailed Description

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This study involves designing/ implementing a patient-centered, individually-focused physical activity (PA) intervention designed for integration into clinical care. We will recruit adult patients (aged 21-70; n=80) from the general internal medicine practice of a local health system who are not meeting the US aerobic activity goal of 150 minutes/ week of at least moderate intensity PA and who can safely increase PA without supervision. As low PA levels have been associated with numerous poor health outcomes, the primary intervention goal will be achievement of the US PA goal. A secondary goal will be to reduce sedentary behavior (SED), which is related to poor health outcomes (independent of PA achievement). Intervention materials will be developed using a patient/provider centered approach and delivered weekly over 3 months via an existing online platform with participants self-tracking behavior outcomes will be examined using a three month wait-listed control design in which all participants will eventually receive the intervention.

Conditions

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Physical Activity Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Participants and their referring physician will be aware of participant randomization. Only the intervention coach, who will also notify the participants of their assignment will be aware of the assignments; other study staff and the investigator will be masked.

Study Groups

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Immediate Intervention

Participants will receive the ActiveGOALS 13 week, online self-directed intervention for increasing aerobic physical activity and decreasing time spent sitting. The intervention is based on social-cognitive theory models of behavior changes and utilizes barrier recognition, problem solving, and monitoring of behavior to initiate behavior change. They will also receive weekly feedback from a coach and be provided with online, paper, and wearable tracking devices. They will also be provided with links to tools that support physical activity.

Group Type EXPERIMENTAL

ActiveGOALs

Intervention Type BEHAVIORAL

13 week, online self-directed intervention. Once weekly sessions are based on social-cognitive theory models of behavior changes. Coaches will provide weekly feedback . Behavior tracking tools will be provided. Links to tools that support physical activity will also be provided.

Wait-listed Control

This group will receive a monthly newsletter with general health advice during the wait period (3 months). After the three month follow-up visit/ collection of outcomes they will be offered the ActiveGOALS intervention in its entirety.

Group Type OTHER

ActiveGOALs

Intervention Type BEHAVIORAL

13 week, online self-directed intervention. Once weekly sessions are based on social-cognitive theory models of behavior changes. Coaches will provide weekly feedback . Behavior tracking tools will be provided. Links to tools that support physical activity will also be provided.

Interventions

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ActiveGOALs

13 week, online self-directed intervention. Once weekly sessions are based on social-cognitive theory models of behavior changes. Coaches will provide weekly feedback . Behavior tracking tools will be provided. Links to tools that support physical activity will also be provided.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* not meeting the recommended levels of aerobic PA and have been identified by their primary care provider (PCP) as able to increase their PA without supervision.

Exclusion Criteria

* Participated in a goal setting intervention for physical activity or a translation of the Diabetes Prevention Program within the last 2 years.
* Non-ambulatory or planning a procedure that will cause them to be non-ambulatory in the next 6 months
* Pregnant or planning a pregnancy in the next 6 months
* Need a way to access to the internet-based platform, at least a 6th grade reading level.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Bonny Rockette-Wagner

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bonny Rockette-Wagner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Rockette-Wagner B, Fischer GS, Kriska AM, Conroy MB, Dunstan D, Roumpz C, McTigue KM. Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 3;9(11):e18891. doi: 10.2196/18891.

Reference Type DERIVED
PMID: 33141103 (View on PubMed)

Other Identifiers

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PRO17120265

Identifier Type: -

Identifier Source: org_study_id

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