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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

April 10, 2012
April 19, 2012
March 2010
May 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01580930 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Changes in Habitual Physical Activity and Inactivity
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Habitual Physical Activity
  • Sedentary Time
  • Behavioral: exercise training
    12 weeks, 5 days of week, 40 min per session of exercise training
  • Behavioral: sedentary time reduction
    participants provided with strategies to decrease sitting
  • 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
  • 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.
    Intervention: Behavioral: exercise training
  • Experimental: Sedentary time reduction
    participants were give strategies to reduce sedentary time
    Intervention: Behavioral: sedentary time reduction
  • 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
    Intervention: Behavioral: exercsie training plus sedentary time reduction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01580930
Kozey-Keadle, RC1HL099557
No
University of Massachusetts, Amherst
University of Massachusetts, Amherst
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
University of Massachusetts, Amherst
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP