Activity Prescription in Clinical Practice

NCT03695016 | Completed DMC

• 1 other identifier: PRO17120265
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Physical Activity; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (3)

• Change in Aerobic activity

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

  10 days of recording at 0 and 3 months

• Change in Step counts

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

  10 days of recording at 0 and 3 months

• Change in sedentary behavior

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

  10 days of recording at 0 and 3 months

Secondary Outcomes (9)

• self-efficacy

  pre-intervention and 3 and 6 months post-intervention

• Referring physician- usability of physicians report

  3 months post-intervention

• Change in Aerobic Activity

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

• Change in Step counts

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

• Change in Sedentary behavior

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

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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.

Behavioral: ActiveGOALs

Wait-listed Control

OTHER

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.

Behavioral: ActiveGOALs

Interventions

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.

Immediate Intervention; Wait-listed Control

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

• 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.

  PMID: 33141103 DERIVED

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Bonny Rockette-Wagner, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 3, 2018
• Study Start: November 9, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)