Changes in Habitual Physical Activity and Inactivity (START)

April 19, 2012 updated by: University of Massachusetts, Amherst

Changes in Physical Activity and Inactivity During a 12-week Exercise Training and/or Sedentary Time Intervention

The purpose of this study is to determine if individuals involved in exercise training change habitual activity and inactivity behavior outside of exercise training. Eligible participants were randomly assigned to one of four groups: control, exercise training, sedentary time reduction, or exercise training plus sedentary time reduction. It was hypothesized that participants in the exercise training group will compensate for exercise training by reducing free-living physical activity behavior and increasing sedentary time. Participant free-living behavior was monitored for one week at baseline, 3, 6, 9 and 12 weeks using an activPAL wearable monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Amherst, Massachusetts, United States, 01003
        • UMass Amherst Physical Activity and Health Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Eligible participants were those at increased risk of cardiovascular disease, based on meeting two of the following three criteria:

  1. Pre-hypertensive: resting blood pressure between 125-160 mm Hg systolic and/or 85-100 mm Hg diastolic,
  2. overweight/obese: body mass index (BMI) between 25 and 45 kg∙m-2,
  3. high central adiposity: as defined by elevated natural waist circumference (> 102 cm [males] > 88cm [females]), a surrogate measure of visceral fat
  4. low aerobic fitness (VO2 peak ≤ 50th percentile of age and sex specific norms)
  5. exercising less than three days per week for less than 20 minutes per session for the preceding six months

Exclusion Criteria:

  • major orthopedic limitations,
  • wheelchair use or musculoskeletal problems that affected mobility,
  • life-threatening illness (e.g., terminal cancer),
  • chronic diseases (e.g., diagnosed heart disease, diabetes, emphysema) or
  • any condition for which a physician did not recommend exercise. Participants were excluded if they had gastric bypass or lap-band surgery within the last year, were taking medication for type II diabetes (e.g. metformin) or beta-blocker medication for high blood pressure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Group had outcome measures collected and were instructed to not change activity and sedentary time behavior
EXPERIMENTAL: Exercise
Participants performed 5 days per week, 40 min per session of exercise training under direct supervision of personal trainer.
Behavioral: exercise training
12 weeks, 5 days of week, 40 min per session of exercise training
EXPERIMENTAL: Sedentary time reduction
participants were give strategies to reduce sedentary time
Behavioral: sedentary time reduction
participants provided with strategies to decrease sitting
EXPERIMENTAL: exercise plus sedentary time reduction
Participants completed exercise training (5 days per week, 40 min per session) plus were given sedentary time reduction intervention
Behavioral: exercsie training plus sedentary time reduction
12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in sedentary time at 3 weeks
Time Frame: 3 weeks
Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking
3 weeks
change from baseline in sedentary time at 6 weeks
Time Frame: 6 weeks
Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking
6 weeks
change from baseline in sedentary time at 9 weeks
Time Frame: 9 weeks
Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking
9 weeks
change from baseline in sedentary time at 12 weeks
Time Frame: 12 weeks
Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in physical activity at 3 weeks
Time Frame: 3 weeks
wearable monitor (activPAL) assesses number of steps, MVPA
3 weeks
change from baseline in physical activity at 6 weeks
Time Frame: 6 weeks
wearable monitor (activPAL) assesses number of steps, MVPA
6 weeks
change from baseline in physical activity at 9 weeks
Time Frame: 9 weeks
wearable monitor (activPAL) assesses number of steps, MVPA
9 weeks
change from baseline in physical activity at 12 weeks
Time Frame: 12 weeks
wearable monitor (activPAL) assesses number of steps, MVPA
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Amherst

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (ESTIMATE)

April 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Kozey-Keadle
  • RC1HL099557 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sedentary Time

Clinical Trials on exercise training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe