Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health: An Adaptive Dose-Finding Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this Phase 1 research study is to answer two questions: (1) How frequent should periods of prolonged sedentary time be interrupted? and (2) What is the appropriate duration or length of time of these breaks in sedentary time? To address these questions, this project will conduct a state-of-the-art adaptive dose finding study under controlled laboratory conditions to determine the minimally effective dose (the smallest dose) that yields cardiometabolic benefit for two separate sedentary break elements (frequency and duration). Study findings will ultimately determine how often and for how long people should break up periods of prolonged sedentary time to transiently improve established cardiovascular risk factors; key foundational information critical to the success of future long-term trials and ultimately public health guidelines. Primary Aim: To determine the minimally effective dose combination(s) of frequency and duration needed to provide cardiometabolic benefit during an 8-hour experimentation period. Specifically, the study will determine: 1a. For each fixed duration, the minimum sedentary break frequency (e.g., every 30 min, 60 min, 120 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control condition. 1b. For each fixed frequency, the minimum sedentary break duration (e.g., activity breaks of 1 min, 5 min, 10 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control. Secondary Aim: It is also critical to public health strategy to assess the acceptability/feasibility of various sedentary break doses as too high a dose will yield poor uptake. To address this need, the maximally tolerated dose (the highest dose that does not cause undue physical/psychological distress) for frequency and duration of sedentary breaks will also be determined via assessment of 4 constructs: physical exhaustion/fatigue, affect (e.g., mood, emotion), tolerability (e.g., completion of dose protocol), and safety (e.g., hypoglycemia). Maximally tolerated dose will be defined as the highest dose where \<20% of participants exhibit an adverse outcome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 18 years of age or older

• Ability to read, write and speak English or Spanish

• Limited or no chronic medical conditions \[examples include but not limited to: CVD, diabetes, chronic obstructive pulmonary disease (COPD), HIV/AIDS; participants with high blood pressure/hypertension and/or high cholesterol/hyperlipidemia may be included if they are currently prescribed and taking medication for these conditions\]

• Do not take medication (over-the-counter or herbal) to control glucose (such as a diabetes control medication)

• Not currently pregnant

• Do not currently smoke cigarettes

• No pre-existing musculoskeletal conditions (including but not limited to osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis) that would prevent participation in intermittent physical activity

• No allergies to common food allergens including wheat, eggs, milk or other dairy, gluten, fructose, peanuts or other nuts

• No dietary restrictions such as vegan, gluten free, halal

Locations
United States
New York
Center for Behavioral Cardiovascular Health
RECRUITING
New York
Contact Information
Primary
Keith Diaz, PhD
kd2442@cumc.columbia.edu
212-305-1170
Backup
Maria Serafini, BS
cbch_break2study@cumc.columbia.edu
347-213-0907
Time Frame
Start Date: 2022-06-30
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 324
Treatments
Experimental: Sedentary Break Condition > Control Condition
Participants will be assigned to the sedentary break or control condition at each lab visit. If assigned to the sedentary break condition at lab visit 1, participants will be assigned to the control condition at visit 2 (and vice versa). During the lab visit, participants will wear a heart rate monitor and ambulatory blood pressure monitor, and eat a controlled diet. Participants will also eat a controlled diet for two days prior to the lab visit.
Experimental: Control Condition > Sedentary Break Condition
Participants will be assigned to the sedentary break or control condition at each lab visit. If assigned to the sedentary break condition at lab visit 1, participants will be assigned to the control condition at visit 2 (and vice versa). During the lab visit, participants will wear a heart rate monitor and ambulatory blood pressure monitor, and eat a controlled diet. Participants will also eat a controlled diet for two days prior to the lab visit.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

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