The Clinical Referral to Activity Study

NCT04743856 | Completed Results

• 2 other identifiers: STUDY200300791K01HL151668-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this effort is to test a physical activity intervention, for adult clinical care patients at risk of developing cardiovascular disease. The intervention includes social-cognitive theory-based sessions, remote coaching, a body worn physical activity tracker (PAT), and is delivered online over one year. The investigators hypothesis that this intervention will be more successful at increasing physical activity (defined as objectively measured step counts and % of individuals meeting the moderate-vigorous physical activity goal) as an active control group who receives a body worn PAT and information on the CDC activity recommendations. The proposed intervention will be aligned with efforts by the US Centers for Disease Control to increase population physical activity levels and the American College of Sports Medicine (ACSM) to increase physical activity prescription in primary care.

Conditions

Physical Inactivity; Cardiovascular Risk Factor; Obesity; Blood Pressure; PreDiabetes

Keywords

Physical activity; Online lifestyle Intervention; Cardiovascular disease; Disease prevention

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months

  Change between 0 and 12 months for y/n meeting the 150 minute/week moderate-vigorous activity goal based on minutes of activity from accelerometer

  12 months versus baseline

• Change From Baseline in Step Counts at 12 Months

  Objectively measured change in step counts between 0 and 12 months using ActiGraph accelerometer

  12 months versus baseline

Secondary Outcomes (15)

• Sedentary Behavior Minutes Over All Timepoints for 12 Months

  1 week recording; measured at baseline, 6 and 12 months

• Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months

  1 week recording; measured at baseline, 6 and 12 months

• Light Activity Minutes Over All Timepoints for 12 Months

  1 week recording; measured at baseline, 6 and 12 months

• Step Counts Over All Timepoints for 12 Months

  1 week recording; measured at baseline, 6 and 12 months

• Patient Experience

  measured at 6 and 12 months

Study Arms (2)

PAT (Physical activity monitor)

ACTIVE COMPARATOR

Participants will receive a physical activity tracker and encouragement to increase physical activity.

Behavioral: PAT

ActiveGOALSv2

EXPERIMENTAL

Participants will receive the ActiveGOALS online program with an integrated activity tracker.

Behavioral: ActiveGOALSv2

Interventions

ActiveGOALSv2 BEHAVIORAL

13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.

ActiveGOALSv2

PAT BEHAVIORAL

Participants will receive a physical activity tracker and encouragement to increase activity.

PAT (Physical activity monitor)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-70 years of age
• Low physical activity (PA) levels (\<150 minutes/week)
• At least one of the following common cardiometabolic risk factors:
• high blood pressure:\> 129 mm hg SP or \>89 mm hg DP or medication
• high fasting glucose:\>100 mg/dl or high HbA1c: ≥42 mmols/mol or medication
• overweight/ obesity: BMI ≥25 kg/m2).
• Have access to the internet
• Able to read English at a 6th grade level
• Have primary care provider (PCP) permission to increase physical activity without supervision.

You may not qualify if:

• Have participated in a physical activity intervention program with behavior tracking and goal setting in the past year.
• Told by a physician that they have diabetes (other than previous gestational diabetes) or have received a diagnosis of cardiovascular disease, regardless of when.
• Pregnant or planning a pregnancy in \<12 months
• Non-ambulatory or planning a procedure that will lead to not being ambulatory in \<12 months.
• Women who become pregnant during the study will be required to get an updated referral form from their primary care provider (PCP) stating that they are able to increase their physical activity without supervision .

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Obesity; Prediabetic State; Motor Activity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This was a small pilot study that was not powered to assess secondary outcomes. The ability to assess the primary outcome of number of participants meeting goal was affected by several factors including: higher than expected participants meeting goal at baseline (based on accelerometers) and higher than expected non-completion rates for the accelerometers.

Results Point of Contact

• Title: Bonny Rockette-Wagner
• Organization: University of Pittsburgh

bjr26@pitt.edu

4126240188

Study Officials

• Bonny Rockette-Wagner, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Referring doctors and outcome assessors will be blinded to participant assignment while the study is active. After data collection ends, referring physicians will be informed as to each of their patients assignment. Outcome assessors will remain blinded to participant assignment. Investigators will be blinded to assignment as much as possible. However, certain events ( such as an adverse event report) may cause the study PI to become unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized 1:1 to one of two intervention conditions.

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: February 8, 2021
• Study Start: March 29, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 10, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)