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Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

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Vanderbilt University

Status

Completed

Conditions

Physical Activity
Type 2 Diabetes
Sedentary Behavior

Treatments

Behavioral: Sit Less Program

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to develop and test an 8-week sedentary behavior reduction intervention ("Sit Less" program) for patients with type 2 diabetes. The program aims to reduce and break sitting times among this population using an objective activity monitor and mHealth. The investigators will test the program to help diabetes patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study preliminary effects of the SB reduction intervention on light physical activity, cardiometabolic markers and patient-centered outcomes, and whether diabetes patients like the program and can follow it.

Full description

The investigators propose to develop and conduct a pilot study to test a wearable technology-based sedentary behavior reduction intervention in type 2 diabetes patients. The participants in the first cohort (n=15), 'Sit Less Version 1' will be randomized to either the control group or the sedentary behavior reduction intervention group. The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. The study will have an iterative design process with multiple cohorts. After the first cohort completed the study, we will collect their feedback to modify the Sit Less program. With Sit Less Version 2, Cohort 2 (n=20) participants will participate in the intervention as a single group, without randomization. The Sit Less Version 2 will be 8 weeks long.

Specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in type 2 diabetes patients by evaluating reach, retention, satisfaction, and compliance with the intervention; evaluate the preliminary efficacy of the sedentary behavior reduction intervention on changes in sedentary time; and explore preliminary effects of the sedentary reduction intervention on physical activity, cardiometabolic markers and patient-centered outcomes.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • ages 18 and above
  • diagnosed with type 2 diabetes
  • self-reported HbA1C<13
  • self-report of sitting ≥ 8hr/day
  • ability to stand and walk
  • ownership of a smartphone.

Exclusion criteria

  • currently using an activity tracker
  • use of insulin
  • random blood glucose >300
  • currently participating in exercise or other research programs
  • non-English speaking
  • patients who are classified as unstable (e.g. heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake, or any other conditions contradictory to standing or walking
  • currently pregnant

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

Intervention Group
Experimental group
Description:
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.
Treatment:
Behavioral: Sit Less Program

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Abigail M Doyle, BS; Chorong Park, PhD

Data sourced from clinicaltrials.gov

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