Take a STAND 4 Health: A Sedentary Behavior Reduction Intervention

NCT03698903 | Completed

• 1 other identifier: Pro00079096
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Keywords

Intervention; Sedentary Behavior; Overweight or obese adults

Outcome Measures

Primary Outcomes (1)

• Change in percent time spent sedentary

  activPAL device

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (9)

• Blood pressure

  Baseline, 1 week, 4 weeks, 8 weeks

• Percent time spent in light physical activity

  Baseline, 4 weeks, 8 weeks

• Percent time spent in moderate-to-vigorous physical activity

  Baseline, 4 weeks, 8 weeks

• Self-reported sedentary behavior

  Baseline, 1 week, 4 weeks, 8 weeks

• Self-reported physical activity

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Take a STAND 4 Health: Immediate

EXPERIMENTAL

Receives the coaching calls + mHealth intervention first, then receives only the mHealth intervention after the 4 week assessment.

Behavioral: Take a STAND 4 Health

Take a STAND 4 Health: Delayed

ACTIVE COMPARATOR

Will receive no intervention for the first 4 weeks but then after assessment will be provided the opportunity to receive the full coaching calls + mHealth intervention.

Behavioral: Take a STAND 4 Health

Interventions

Take a STAND 4 Health BEHAVIORAL

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.

Take a STAND 4 Health: Delayed; Take a STAND 4 Health: Immediate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years or older
• Having a BMI between 25 and 50 kg/m2
• Owning a smartphone that is accessible during the day
• Living or working within 30 miles of University of South Carolina (USC)
• Willing to wear the activPAL for baseline assessment
• An average self-reported sedentary time of at least 7 hours over the past 7 days
• Willing to be randomized to either group

You may not qualify if:

• Inability to walk without assistance
• Recent use of psychotropic medications or treatment for psychological issues, with the exception of anxiety and depression
• Current treatment for cancer or other serious medical conditions such as renal failure
• Injury or illness that prohibits standing or walking
• Pregnant or gave birth within the last 6 months
• Does not live or work within 30 miles of USC
• Currently enrolled in a weight loss, physical activity, or stress management program
• A known vacation or a major alteration in their normal schedule in the next 4 months
• Unwilling to wear the accelerometer for 7 days at any assessment period or had an adverse reaction to wearing the accelerometer during baseline

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29223, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Overweight

Condition Hierarchy (Ancestors)

Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chelsea Larsen, MPH

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: October 9, 2018
• Study Start: August 1, 2018
• Primary Completion: October 30, 2019
• Study Completion: November 15, 2019
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

US (1)