Changes in Habitual Physical Activity and Inactivity (START)
This study has been completed.
Sponsor:
University of Massachusetts, Amherst
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
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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:
- Pre-hypertensive: resting blood pressure between 125-160 mm Hg systolic and/or 85-100 mm Hg diastolic,
- overweight/obese: body mass index (BMI) between 25 and 45 kg∙m-2,
- high central adiposity: as defined by elevated natural waist circumference (> 102 cm [males] > 88cm [females]), a surrogate measure of visceral fat
- low aerobic fitness (VO2 peak ≤ 50th percentile of age and sex specific norms)
- 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 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 October 17, 2012
