University of South Carolina
Columbia, South Carolina, 29223, United States
NCT Number: NCT03698903
There is emerging evidence that an excessive amount of sitting is linked with an increased risk of negative health outcomes independent of an individual's physical activity levels. This is concerning considering data indicate Americans spend over half of the waking day engaged in sedentary activities, and that individuals who are overweight or obese and/or have a chronic disease such as hypertension are likely to have an even higher level of sedentary behavior. A limited number of experimental studies have looked at the effects of reducing sitting time on blood pressure and have shown promise. However, these studies lasted for only a day, so it is unclear how reducing sedentary time may influence blood pressure over a longer duration. The purpose of this study is to look the relationships between the amount of time a person spends sitting and their blood pressure and examine whether decreasing sedentary behavior helps improve blood pressure. The study employs the use of coaching calls and a mobile health (mHealth) intervention to reduce the sedentary behavior of participants through strategies such as prompting, feedback, and counseling.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Columbia, South Carolina, 29223, United States
The purpose of this study is to determine the effect of a 4-week sedentary behavior reduction intervention on objectively measured sedentary behavior of overweight or obese adults. The proposed study is a pilot, proof-of-concept randomized controlled trial that will randomize participants to either the 1) Immediate Intervention group, which will receive coaching calls + a mHealth intervention for the first four weeks of the study and then will receive only the mHealth intervention for the remaining 4 weeks or the 2) Delayed Intervention Control group, which will act as an assessment-only condition for the first 4 weeks and then will receive the coaching calls + mHealth intervention for 4-weeks. This design has two phases: Phase 1, which is a randomized controlled feasibility pilot and the primary study focus, followed by Phase 2, which is an exploratory phase, allowing replication of the intervention (in the Delayed Intervention Control group) and extended follow-up (in the Immediate Intervention group).
The study outcomes to be investigated in Phase 1 include:
The study outcomes to be investigated in Phase 2 include:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 4-week is comprised of several elements, including: (1) an in-person introductory session to acquaint the individuals with all intervention elements, customize to their preferences and describe the mHealth component of the intervention; (2) a website that will provide individualized feedback over time on the participant's scheduled breaks, sedentary time reduction, and sedentary patterns; (3) texts to serve as prompts and alert the participant to stand or move, with a goal of a 60 minute reduction per day, which are customized to the individual's schedule, personal preference and sedentary profile; and (4) two coaching phone calls to trouble shoot and problem solve implementation of the intervention.
Time frame: Baseline, 4 weeks, 8 weeks
activPAL device
Time frame: Baseline, 1 week, 4 weeks, 8 weeks
Automated blood pressure machine
Time frame: Baseline, 4 weeks, 8 weeks
activPAL device
Time frame: Baseline, 4 weeks, 8 weeks
activPAL device
Time frame: Baseline, 1 week, 4 weeks, 8 weeks
The Sedentary Behavior Questionnaire is assesses domain specific sedentary time on both a weekday and weekend. The scale ranges from "none" to "6 or more hours" for each sedentary activity, with a higher value indicating a higher amount of sedentary time. All responses are summed and the value is the individuals sedentary time.
Time frame: Baseline, 4 weeks, 8 weeks
The International Physical Activity Questionnaire- Short form measures the frequency (0-7 days) and amount of time (number of hours and minutes) an individual spends in vigorous intensity physical activity, moderate intensity physical activity, and walking. The total number of metabolic equivalent (MET) minutes per week are calculated from these responses. The survey also assess an individuals total sedentary time on a weekday.
Time frame: Baseline, 1 week, 4 weeks, 8 weeks
Gulick tape
Time frame: Baseline, 1 week, 4 weeks, 8 weeks
Calibrated Tanita body weight scale that measures weight in both pounds and kilograms.
Time frame: Baseline
Stadiometer
Time frame: 4 weeks, 8 weeks
Survey
University of South Carolina
Other
Evaluating the Effects of a Sedentary Behavior Reduction Intervention on the Sedentary Time and Blood Pressure of Overweight/Obese Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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