Reducing Sedentary Behavior to Improve Sleep: an Ancillary Study to the RESET BP Clinical Trial

NCT03946228 | Completed DMC

• 2 other identifiers: STUDY18120122R01HL147610
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

Using a multi-method sleep assessment approach, the purpose of this study is to examine the bidirectional relationship between sleep and sedentary behavior in the context of a randomized trial investigating the impact of sedentary behavior reduction on blood pressure.

Conditions

Sleep; Obstructive Sleep Apnea; Insomnia

Keywords

blood pressure; sedentary behavior; physical activity

Outcome Measures

Primary Outcomes (3)

• Change from baseline actigraphic wake after sleep onset (WASO) at 3 months

  Primary outcome for Aim 1: actigraphy-assessed wake after sleep onset, averaged over 7 nights

  3 months

• Change from baseline activPAL-assessed sedentary behavior (SED) at 3 months

  Primary outcome for Aim 2: SED, assessed via activPAL inclinometer, averaged over 7 days

  3 months

• Change from baseline resting systolic blood pressure (SBP) at 3 months

  Primary outcome for Aim 2: resting SBP, measured via oscillometric device following a 10-minute rest averaged over two separate occasions

  3 months

Secondary Outcomes (5)

• Change from baseline total sleep time (TST) at 3 months

  3 months

• Change from baseline apnea-hypopnea index (AHI) at 3 months

  3 months

• Change from baseline slow-wave sleep (SWS) at 3 months

  3 months

• Change from baseline 24-hour blood pressure at 3 months

  3 months

• Change from baseline pulse wave velocity (PWV) at 3 months

  3 months

Other Outcomes (12)

• Change from baseline self-reported sleep patterns at 3 months

  3 months

• Change from baseline Epworth Sleepiness Scale (ESS) scores at 3 months

  3 months

• Change from baseline Insomnia Severity Index (ISI) scores at 3 months

  3 months

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.

Behavioral: Behavioral Intervention

Control Condition

NO INTERVENTION

Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.

Interventions

Behavioral Intervention BEHAVIORAL

The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3.

Behavioral Intervention

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65 years
• SBP of 120-159 mmHg or DBP of 80-99 mmHg
• Physically inactive or insufficiently active (i.e., not meeting current aerobic MVPA recommendations \[≥150 min/wk\])
• Currently perform deskwork for ≥ 20 hr/wk at a desk compatible with a sit-stand desk attachment
• Employment within 25-mi radius of University of Pittsburgh
• Stable employment (≥ 3 mo at current job, plan to be in current job for at least the next 3 mo)
• Supervisor approval to join intervention
• Possession of cellular phone able to receive text messages

You may not qualify if:

• SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
• Use of anti-hypertensive or glucose-controlling medication
• Comorbid condition that would limit ability to reduce sedentary behavior (e.g., musculoskeletal condition)
• History of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
• Inability to obtain consent from primary care provider/physician to participate
• Current use of a sit-stand desk or sedentary behavior prompting device
• Current enrollment in a weight loss or exercise program, recent (\< 1 yr) or planned bariatric surgery
• Plans to be away from work for an extended period (\>1 wk) during the study period
• Current or recent (within last 6 mo) pregnancy; current or recent (within last 3 mo) breastfeeding
• Undiagnosed severe OSA (AHI ≥ 30) or insomnia (ISI ≥ 22)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh Physical Activity and Weight Management Research Center

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Sedentary Behavior; Motor Activity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christopher E Kline, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: May 6, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 1 year following peer-reviewed publication of research questions outlined in grant and ending 5 years following publication of study results
• Access Criteria: Data access will be provided to external researchers who provide a methodologically sound proposal for secondary data analysis that is approved by the investigators of the study. Proposals should be directed to the study PI.

Locations

US (1)