Pre-diabetes study: BREAK vs ONE
Official title Breaking up Sedentary Time to Improve Glucose Control in a Population at Risk for Developing Type 2 Diabetes
ClinicalTrials.gov ID: NCT05041491
What this study is testing
- What it's testing
- The study will see whether breaking up long periods of sitting with brief walks helps control glucose levels and whether this effect lasts over time.
- Who it's for
- Adults with pre‑diabetes, both men and women, about 66 participants in total.
- What's involved
- Participants will either walk briskly for 5 minutes every hour for 9 hours a day, five days a week, or walk briskly for 45 minutes in one continuous session each day. Both groups will have the same total walking time.
- Time commitment
- The program lasts 3 months, with daily walking sessions and regular check‑ins to track glucose and other health measures.
- Phase 1: an early, usually small safety study
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Male and female
- BMI of 18.5-40 kg/m2 and weight stable over the previous 6 months.
- Age, 18-64 years old.
- Fasting glucose of 100-125 mg/dL or fasting HbA1c of 5.7-6.4%, or 2h OGTT blood glucose of 140-199mg/dL based on the American Diabetes Association...
- Less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week and more than 6 hours of sitting time per day, as self-reported by...
You likely can't join if
- Pregnancy, breast-feeding or post-menopause for women.
- Being considered unsafe to participate as determined by the study physician.
- Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse.
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical...
- Being positive for human immunodeficiency virus or hepatitis B or C.
- Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months.
See the full eligibility criteria
- Male and female
- BMI of 18.5-40 kg/m2 and weight stable over the previous 6 months.
- Age, 18-64 years old.
- Fasting glucose of 100-125 mg/dL or fasting HbA1c of 5.7-6.4%, or 2h OGTT blood glucose of 140-199mg/dL based on the American Diabetes Association criteria for pre-diabetes.
- Less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week and more than 6 hours of sitting time per day, as self-reported by the volunteers using the International Physical Activity Questionnaire...
- Less than 6500 of steps per day as measured by a pedometer over 5 days (at least 1 weekend day).
- Passing medical and physical screening, and analysis of blood and urine screening samples.
- Low-moderate caffeine use (\<3 cups/day).
- Agree to refrain from any other structured exercise than the physical activity prescribed in each arm of the study.
- Agree to eat control diets for 3 days before and during the Clinical and Translational Research Center (CTRC) visits;
- Agree to refrain from taking any over-the-counter (including nonsteroidal anti-inflammatory drugs) or prescribed medication (apart from oral contraceptives) for 3 days prior to the inpatient CTRC visits;
- Agree to wear a Fitbit® activity monitor and upload data on the website on a daily basis for the whole duration of the study.
- Agree to follow the physical activity interventions and to be randomly assigned to one of the two arms of the study.
- Agree to complete all the study procedures.
- Pregnancy, breast-feeding or post-menopause for women.
- Being considered unsafe to participate as determined by the study physician.
- Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse.
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism.
- Being positive for human immunodeficiency virus or hepatitis B or C.
- Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months.
- Having abnormal blood chemistry and/or hematology as deemed significant by the study physician.
- Being a smoker or having been a smoker in the 3 months prior to their screening visit.
- Having donated over 400 mL of blood within 3 months (90 days) of screening for the study;
- Working night shifts within 1 month of and throughout the study.
- Not completing the trial days of BREAK and ONE during the screening period to assess the willingness and ability of the participant to perform each of the interventions.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.