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Completed

NCT Number: NCT03695016

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.

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Key information

Conditions

Physical Activity Behavior Motor Activity Sedentary Behavior Sedentary Lifestyle

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ActiveGOALs

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.

Primary outcomes

  1. Change in Aerobic activity

    Time frame: 10 days of recording at 0 and 3 months

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

  2. Change in Step counts

    Time frame: 10 days of recording at 0 and 3 months

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

  3. Change in sedentary behavior

    Time frame: 10 days of recording at 0 and 3 months

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

Secondary outcomes

  1. self-efficacy

    Time frame: pre-intervention and 3 and 6 months post-intervention

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

  2. Referring physician- usability of physicians report

    Time frame: 3 months post-intervention

    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).

  3. Change in Aerobic Activity

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

    Change in objectively measured moderate-vigorous activity from ActiGraph accelerometer

  4. Change in Step counts

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

    Change in objectively measured step counts from ActiGraph accelerometer

  5. Change in Sedentary behavior

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

    Change in objectively measured sedentary behavior from ActiGraph accelerometer

  6. Patient experience

    Time frame: 3 and 6 months post-intervention

    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.

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

    Time frame: pre-intervention and 3 and 6 months post-intervention

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

  8. Participant cost

    Time frame: pre-intervention and 3 and 6 months post-intervention

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

  9. Perceived Health Score

    Time frame: pre-intervention and 3 and 6 months post-intervention

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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Advancement of Physical Activity Prescription in Clinical Practice

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2018
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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