NCT04286919

Brief Summary

Practical interventions are needed to increase physical activity (PA) levels in insufficiently active individuals. HEAT is a randomized controlled trial comparing two different exercise prescription (ExRx) methods to increase PA volume among insufficiently active UConn students. Students will be randomized to two groups: (1) ExRx#1 will emphasize meeting the Physical Activity Guidelines for Americans via the Frequency, Intensity, Time, and Type or FITT principle of ExRx; and (2) ExRx#2 will be founded in the Integrated Behavior Change Theory and based on the 2018 Physical Activity Guidelines Review Committee Scientific Report heat map which emphasizes that all PA counts. HEAT aims to assess the effectiveness of each ExRx individually and comparatively to one another for each outcome measure. We hypothesize that UConn students in ExRx#2 will increase PA volume more than ExRx#1 in response to the 12wk ExRx due to its foundation in the IBC. If our hypothesis proves correct we aim to inform healthcare providers on university campuses on which method of ExRx is more effective at increasing PA participation among their insufficiently active students.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

February 20, 2020

Last Update Submit

August 6, 2020

Conditions

Keywords

ExerciseAdherence

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Volume change from Baseline to 12 weeks

    Actical® (Mini Meter, Respironics Inc.) accelerometers will be given to participants to wear on their hip for 4 consecutive days including 2 weekdays and 2 weekend days as an objective measure of PA volume in MET-hours/day. This data will be collected at baseline before the exercise guidelines start and at week 12 of the exercise guidelines to measure change from baseline to 12 weeks.

    12 weeks

Secondary Outcomes (1)

  • Autonomy Score Change from Baseline to 12 weeks

    12 weeks

Study Arms (2)

ExRx#1: Physical Activity Guidelines

ACTIVE COMPARATOR

ExRx#1 uses the Frequency, Intensity, Time, and Type or FITT principle of exercise prescription to prescribe the Physical Activity Guidelines for Americans which is a weekly goal of 150-minutes of moderate intensity aerobic physical activity plus 2 days of muscle strengthening physical activity. ExRx#1 communicates the ultimate goal of the physical activity guidelines for Americans using an image adopted from the physical activity guidelines website that depicts the weekly goal. There are 12 weeks of exercise guidelines that will progress participants from being physically inactive to meeting the physical activity guidelines ultimate weekly goal by providing a weekly prescription of Frequency, Intensity, Time, and Type of physical activity that accomplishes meeting the physical activity guidelines weekly goal.

Behavioral: A Randomized Controlled Trial Comparing the Physical Activity Guidelines for Americans to a New Method of Exercise Prescription Among College Students

ExRx#2: Heat Map

EXPERIMENTAL

ExRx#2 uses the heat map image published in the 2018 Physical Activity Guidelines Advisory Committee Scientific Report that communicates the dose-response relationship between increased physical activity and improved health to prescribe the message that all physical activity across all Frequencies, Intensities, Time bouts and Types (FITT) counts towards health. ExRx#2 is founded in the Integrated Behavior Change Theory and emphasizes that all physical activity matters regardless of FITT as depicted by the heat map image. There are 12 weeks of exercise guidelines that will progress participants from being physically inactive to meeting the ExRx#2 heat map ultimate weekly goal of moving more throughout the day across all intensities in order to achieve optimal health as represented by the deep green color on the bottom right of the heat map image.

Behavioral: A Randomized Controlled Trial Comparing the Physical Activity Guidelines for Americans to a New Method of Exercise Prescription Among College Students

Interventions

A randomized controlled trial comparing the 2018 Physical Activity Guidelines for Americans weekly recommendations of 150-minutes of moderate intensity physical activity plus 2 days of muscle-strengthening physical activity to the Move Your Way Campaign message of increasing any and all physical activity to accumulate more movement throughout the week across all types and intensities.

Also known as: Comparing the Physical Activity Guidelines for Americans to The Move Your Way Campaign Methods of Exercise Prescription Among College Students
ExRx#1: Physical Activity GuidelinesExRx#2: Heat Map

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years old.
  • Participants will attend UConn Storrs campus as an undergraduate or graduate student during the study.
  • Participants must be physically inactive as defined by participating in less than or equal to 2 days of planned, structured physical activity over the past 12 weeks.
  • Any and all races may be included.
  • Participants will be healthy with no diagnosed cardiovascular, pulmonary, metabolic, or other chronic diseases or depression and not taking medication for any of these chronic diseases or health conditions as defined by answering "no" to all General Health Questions listed in the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
  • Anyone scoring less than a 19 on the Beck Depression Inventory.
  • Those who answer "yes" to 3 or less on the eating questionnaire will be included.
  • Between 18-35 m2/kg.
  • Participants should be non-smokers for at least 6 months prior to entry.
  • Participants should drink \<2 alcoholic drinks daily.
  • Women who are not pregnant or lactating and do not plan on becoming pregnant.
  • Participants with no arthritis or orthopedic problems inhibiting their ability to exercise across all intensities without exacerbating the problem.
  • Participants willing to maintain their habitual diet throughout the study.
  • Participants wanting to enter the study for reasons that do not include weight loss.
  • Participants should be willing and able to consent to all data collection processes including the intended timeline of the study procedures as well as all questionnaires, fitness assessments, and physical activity monitor usage.
  • +1 more criteria

You may not qualify if:

  • \<18 years old
  • Not attending UConn Storrs campus during the duration of their enrollment.
  • Participating in more than 2 days of planned, structured physical activity over the past 12 weeks.
  • Unhealthy students as determined by answering "yes" to any question listed on the PAR-Q+.
  • Scoring a 19 or higher on the Beck Depression Inventory.
  • Those who answer "yes" to more than 3 statements on the SCOFF eating disorder questionnaire will be excluded.
  • BMI \<18 or \>35 m2/kg.
  • People who currently smoke, plan on smoking or have smoked tobacco within the last 6 months.
  • People drinking 2 or more alcoholic drinks daily.
  • Women who are pregnant or lactating.
  • People with arthritis or orthopedic problems will not be enrolled if these conditions compromise their completion of the exercise protocols or ability to exercise across all intensities.
  • People unwilling to maintain their habitual diet as we request throughout study participation.
  • We will not recruit subjects whose primary motivation for enrolling is to lose weight.
  • People who do not think they will be able to complete all study protocols at the times they are scheduled to complete them. This includes the completion of study time logs and all study visits.
  • Anyone not willing to confirm that they will refrain from obtaining another exercise program or viewing that of the other group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06268, United States

Location

Related Publications (39)

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Related Links

MeSH Terms

Conditions

Motor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Linda S Pescatello, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants do not know that there is another group getting a different exercise prescription. At the end of their participation, all participants will be offered the other exercise prescription.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial with 1 control group and 1 intervention group. The control group is getting the standard of care exercise prescription based on the 2018 physical activity guidelines for Americans and the intervention group is getting a new method of prescribing exercise based on new research informing the 2018 Move Your Way initiative where all physical activity across all types and intensities is advised.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 27, 2020

Study Start

February 22, 2019

Primary Completion

May 28, 2020

Study Completion

May 28, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared. All data will be analyzed and presented in aggregate as accepted by the University of Connecticut IRB.

Locations