Changes in Habitual Physical Activity and Inactivity (START)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Massachusetts, Amherst
ClinicalTrials.gov Identifier:
NCT01580930
First received: April 10, 2012
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Habitual Physical Activity
Sedentary Time
Behavioral: exercise training
Behavioral: sedentary time reduction
Behavioral: exercsie training plus sedentary time reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changes in Physical Activity and Inactivity During a 12-week Exercise Training and/or Sedentary Time Intervention

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Amherst:

Primary Outcome Measures:
  • change from baseline in sedentary time at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking

  • change from baseline in sedentary time at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking

  • change from baseline in sedentary time at 9 weeks [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking

  • change from baseline in sedentary time at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure is based on data collected with a wearable monitor that assesses time spent sitting/lying, standing, and walking


Secondary Outcome Measures:
  • change from baseline in physical activity at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    wearable monitor (activPAL) assesses number of steps, MVPA

  • change from baseline in physical activity at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    wearable monitor (activPAL) assesses number of steps, MVPA

  • change from baseline in physical activity at 9 weeks [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    wearable monitor (activPAL) assesses number of steps, MVPA

  • change from baseline in physical activity at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    wearable monitor (activPAL) assesses number of steps, MVPA


Enrollment: 57
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580930

Locations
United States, Massachusetts
UMass Amherst Physical Activity and Health Lab
Amherst, Massachusetts, United States, 01003
Sponsors and Collaborators
University of Massachusetts, Amherst
  More Information

No publications provided

Responsible Party: University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT01580930     History of Changes
Other Study ID Numbers: Kozey-Keadle, RC1HL099557
Study First Received: April 10, 2012
Last Updated: April 19, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Massachusetts, Amherst:
physical inactivity
exercise training
sedentary time
habitual physical activity

ClinicalTrials.gov processed this record on August 18, 2014