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Physical ActivityNCT03695016

Activity Prescription in Clinical Practice

A study testing ActiveGOALs in people with Physical Activity and Sedentary Lifestyle, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Physical Activity, Sedentary Lifestyle
What is being tested?
ActiveGOALs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteUnited States
Study dates
9 Nov 2018to 30 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

Official title: Advancement of Physical Activity Prescription in Clinical Practice

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.

Read the detailed description

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.

Being tested
ActiveGOALs
Medical subject headings
Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActiveGOALsBehavioural

    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.

Study groups in NCT03695016
Study groupRoleWhat they receive
Immediate InterventionExperimentalParticipants 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.
Receives: Behavioral: ActiveGOALs
Wait-listed ControlOtherThis 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.
Receives: Behavioral: ActiveGOALs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Aerobic activity

    Objectively measured change in moderate-vigorous activity between 0 and 3 months using ActiGraph accelerometer

    Measured: 10 days of recording at 0 and 3 months

  2. Change in Step counts

    Objectively measured change in step counts between 0 and 3 months using ActiGraph accelerometer

    Measured: 10 days of recording at 0 and 3 months

  3. Change in sedentary behavior

    Objectively measured change in sedentary behavior between 0 and 3 months using ActiGraph accelerometer

    Measured: 10 days of recording at 0 and 3 months

Secondary outcomes (9)

  1. self-efficacy

    questionnaire developed for this study, uses a 10 point scale.

    Measured: pre-intervention and 3 and 6 months post-intervention

  2. Referring physician- usability of physicians report

    Physician satisfaction with study reports using questionnaire developed for this study. Several likert scale-based questions to determine satisfaction with different aspects of the report (design, readability, and aspects of usability).

    Measured: 3 months post-intervention

  3. Change in Aerobic Activity

    Change in objectively measured moderate-vigorous activity from ActiGraph accelerometer

    Measured: 10 days of recording pre and post-intervention (3 and 6 months post)

  4. Change in Step counts

    Change in objectively measured step counts from ActiGraph accelerometer

    Measured: 10 days of recording pre and post-intervention (3 and 6 months post)

  5. Change in Sedentary behavior

    Change in objectively measured sedentary behavior from ActiGraph accelerometer

    Measured: 10 days of recording pre and post-intervention (3 and 6 months post)

  6. Patient experience

    patient experience survey designed for this study with the help of patient partners to gather feedback from participants. Feedback will be used in the development of future interventions.

    Measured: 3 and 6 months post-intervention

  7. Health-related Quality of Life- PROMIS-29 score

    Promis 29- Likert scale based questionnaire that determines quality of life in 7 areas of health with 4 questions in each area.

    Measured: pre-intervention and 3 and 6 months post-intervention

  8. Participant cost

    Cost survey questionnaire developed specifically for this study to determine health and personal monetary costs associated with participation in this study.

    Measured: pre-intervention and 3 and 6 months post-intervention

  9. Perceived Health Score

    EQ-VAX- Determines current perception of health on a 0-100 scale.

    Measured: pre-intervention and 3 and 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start9 Nov 2018
  3. Primary completion30 Mar 2020
  4. Study completion30 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03695016
Sponsor's protocol ID
PRO17120265
Status last verified
Feb 2025
First submitted
28 Sep 2018
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33141103

Questions about this trial

What is this clinical trial studying?

A study testing ActiveGOALs in people with Physical Activity and Sedentary Lifestyle, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Aerobic activity (time frame: 10 days of recording at 0 and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03695016, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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