The Clinical Referral to Activity Study

Obesity Clinical Trial

Official title:

Advancement of Clinical Referral to Physical Activity for Cardiometabolic Disease Prevention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04743856
• Other study ID #: STUDY20030079
• Secondary ID: 1K01HL151668-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 13 weekly and 6 monthly social-cognitive theory-based sessions, remote coaching, a body worn physical activity tracker (PAT), and is delivered online over one year.

A total of n=54 Clinical care patients aged 40-70 years of age with low physical activity (PA) levels (<150 minutes/week) at risk for cardiovascular disease will be recruited. Study outcomes will be measured at baseline, 6 months after intervention start and 12 months after intervention start.

For the primary outcomes, the investigators hypothesize that participants randomized to ActiveGOALSv2 + PAT will have significantly larger (a) increases in step counts/day and % meeting moderate-vigorous physical activity goal of 150 minutes/week (to 12 months) compared to the active PAT control group. Descriptive analyses and graphic displays will be used to identify outliers, missing data, and pattern of attrition. To ensure rigor, the primary analytic strategy will be a linear or generalized mixed-effect models approach in which treatment group, time, and time by group interaction are treated as fixed effects, and subject is treated as a random effect to account for individual subject variability (two sided hypothesis test; .05 level). Mixed models are applicable to longitudinal datasets that contain missing observations, (assuming data is missing at random). Regression modeling will be conducted to adjust for important covariates. The investigators will perform similar analyses to examine changes in secondary outcomes. Descriptive statistics on patient experience, beliefs/attitudes related to maintenance of physical activity changes, and program cost will also be reported.

Power and sample size: For a 2 sided test with alpha level set at .05, and assuming 20% attrition at 12 months, the investigators plan to recruit 54 participants to identify clinically relevant mean difference between randomized groups at 12-months of 2000 steps/day (with a power of .80), and 35% meeting MVPA goal (with a power of .80), given reference mean (sd) values were calculated from baseline waist worn accelerometer data from the current K12 of: 5250 (2200) steps/ day and the investigators assume 5% meeting goal at baseline in the control group.

Descriptive statistics will be used to describe the total eligible population, those referred, and those referred who participated in the study; in order to determine program reach. Exploratory Analysis of Important Pre-Existing Factors: Factor analysis will be used to identify importance of factors related to physical activity levels/ activity goal achievement over the 12 month follow-up (Mplus) from participant EHR data collected prior to intervention start. Factor structures of how individual factors contribute to activity outcomes will be explored at each time point. The best factor structure will be determined with Eigenvalues and fit indices (RMSEA, CFI, and TLI). Factor structures at the 2 time points will be compared at three levels to establish measurement invariance: 1) Configural equivalence, number of factors/ pattern of factor-indicator relationships are identical over time; 2) Metric equivalence, factor loadings are equal over time; and 3) Scalar equivalence, means and values are equivalent over time. Finally, the investigators will use descriptive statistics to report presence/absence of data on physical activity levels, cardiometabolic, and patient-centered outcomes in the EHR. The investigators will apply the same regression approaches utilized in Aim 1a to determine differences between randomized groups for EHR reported outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 .

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Risk Factor
• Obesity
• Physical Inactivity
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• ActiveGOALSv2
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.
• PAT
Participants will receive a physical activity tracker and encouragement to increase activity.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sedentary behavior minutes over all timepoints for 12 months	Objectively measured sedentary behavior over all timepoints for 12 months using ActiGraph accelerometer	1 week recording; measured at baseline, 6 and 12 months
Secondary	Moderate-vigorous activity minutes over all timepoints for 12 months	Objectively measured moderate-vigorous activity over all timepoints for 12 months using ActiGraph accelerometer	1 week recording; measured at baseline, 6 and 12 months
Secondary	Light activity minutes over all timepoints for 12 months	Objectively measured Light activity over all timepoints for 12 months using ActiGraph accelerometer	1 week recording; measured at baseline, 6 and 12 months
Secondary	Step counts over all timepoints for 12 months	Objectively measured Step counts over all timepoints for 12 months using ActiGraph accelerometer	1 week recording; measured at baseline, 6 and 12 months
Secondary	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 at 6 and 12 months
Secondary	Blood Pressure over all timepoints for 12 months	Taken by trained clinic staff using a validated automated blood pressure cuff after participant is seated in an upright position for 5 minutes. Two measure will be taken and the average of the two measures will be used. If the measures are not within 5 mmHG, a third measure will be taken.	measured at baseline, 6 and 12 months
Secondary	Body Weight over all timepoints for 12 months	will be measured in clinic by trained staff using a validated scale. Participants will be asked to take shoes off and wear light clothes. Average of two measures will be used; if weight is more than .5 pounds different, a third will be taken.	measured at baseline, 6 and 12 months
Secondary	Waist Circumference over all timepoints for 12 months	will be measured above the iliac crest in clinic by trained staff. Two measures will be taken and averaged; if measures are more than 1 cm different a third measure will be taken.	measured at baseline, 6 and 12 months
Secondary	Fasting Blood Glucose over all timepoints for 12 months	A fasting blood draw will be taken after 12-16 hours fast.	measured at baseline, 6 and 12 months
Secondary	HbA1c over all timepoints for 12 months	A fasting blood draw will be taken after 12-16 hours fast.	measured at baseline, 6 and 12 months
Secondary	LDL Cholesterol over all timepoints for 12 months	A fasting blood draw will be taken after 12-16 hours fast.	measured at baseline, 6 and 12 months
Secondary	HDL Cholesterol over all timepoints for 12 months	A fasting blood draw will be taken after 12-16 hours fast.	measured at baseline, 6 and 12 months
Secondary	Perceived Health Score over all timepoints for 12 months	EuroQAL Visual Analogue Scale (EQ-VAS)-Self-reported perception of health on a 0 (lowest possible) to 100 (highest possible) scale.	measured at baseline, 6 and 12 months
Secondary	Insulin over all timepoints for 12 months	A fasting blood draw will be taken after 12-16 hours fast.	measured at baseline, 6 and 12 months
Secondary	Triglycerides over all timepoints for 12 months	A fasting blood draw will be taken after 12-16 hours fast.	measured at baseline, 6 and 12 months