Sit Less Program for Patients With Type 2 Diabetes

NCT06457802 | Terminated Results

• 1 other identifier: 240549
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate an 8-week intervention designed to reduce sedentary behavior (SB) in patients with type 2 diabetes (T2D) using wearable technology. The intervention involves the use of Fitbit devices to prompt standing/walking breaks, a smart water bottle to encourage hydration-related movement, and tailored text messages for behavior reinforcement. Participants will be assessed at baseline and post-intervention for changes in SB, light physical activity, cardiometabolic markers, and patient-centered outcomes. The study seeks to determine the intervention's acceptability and preliminary efficacy in reducing SB and improving health outcomes in T2D patients.

Conditions

Type 2 Diabetes; Sedentary Behavior; Sedentary Time; Physical Activity

Outcome Measures

Primary Outcomes (6)

• Change in Total Sedentary Behavior Time

  The primary outcome measure will assess the change in total sedentary behavior (SB) time from baseline to post-intervention. Sedentary behavior will be objectively measured using the activPAL device, which participants will wear on their thigh for 7 days at both baseline and post-intervention. The activPAL device will record the amount of time participants spend sitting or lying down during waking hours each day.

  Baseline and 8 weeks post-intervention

• Acceptability of the Sedentary Behavior Reduction Intervention

  Satisfaction will be assessed using a 23-item questionnaire. This questionnaire includes items on the perceived helpfulness, ease of use, and overall experience with the wearable devices, text messages, and goal-setting sessions. The questionnaire uses a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater satisfaction with the intervention.

  8 weeks post-intervention

• Usability of the Sedentary Behavior Reduction Intervention

  Usability will be assessed using a 10-item System Usability Scale. The System Usability Scale provides a global measure of usability and uses a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It has a minimum score of 0 and a maximum score of 100, where higher scores indicate better usability.

  8 weeks post-intervention

• Compliance With the Sedentary Behavior Reduction Intervention - Fitbit Usage

  Compliance with the intervention will be evaluated by tracking the usage data from the Fitbit devices, specifically the number of days the device was worn for at least 10 hours per day.

  8 weeks post-intervention

• Adherence to Sedentary Behavior Goals

  Adherence will be evaluated by tracking the percentage of set sedentary behavior reduction goals met by participants.

  8 weeks post-intervention

• Response Rates to Tailored Text Messages

  Compliance will be evaluated by tracking the response rates (percentage) to the tailored text messages sent as part of the intervention.

  8 weeks post-intervention

Secondary Outcomes (9)

• Change in Number of Prolonged Sedentary Bouts

  Baseline and 8 weeks post-intervention

• Change in Light Physical Activity

  Baseline and 8 weeks post-intervention

• Change in 24-Hour Glycemic Control (GMI)

  Baseline and 8 weeks post-intervention

• Change in Body Mass Index (BMI)

  Baseline and 8 weeks post-intervention

• Change in Waist Circumference

  Baseline and 8 weeks post-intervention

Study Arms (2)

Sit Less Group - mHealth intervention

EXPERIMENTAL

The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. Outcomes will be measured at baseline and post-intervention.

Behavioral: Sit Less Program

Control Group - Standard Care

NO INTERVENTION

Participants in the control group will receive standard care, including educational materials from the American Heart Association's Healthy Living booklet and a Fitbit. They will not receive the smart water bottle or the tailored text messages aimed at reducing sedentary behavior. The Fitbit move alert setting will be disabled for the control group.

Interventions

Sit Less Program BEHAVIORAL

The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. Outcomes will be measured at baseline and post-intervention.

Sit Less Group - mHealth intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• currently using an activity tracker
• currently participating in exercise or other research programs.
• random blood glucose \> 300 mg/dL.
• non-English speaking.
• patients classified as unstable (e.g., heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake.
• any conditions that prevent standing or walking due to physical or cognitive limitations, such as cognitive impairment, severe pain, problems with lower limbs, or a history of surgeries that limit movement.
• participation in Sit Less Program V1 (IRB #221566).
• currently pregnant.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Results Point of Contact

• Title: Dr. Shelagh Mulvaney, PhD
• Organization: Vanderbilt University School of Nursing

shelagh.mulvaney@vanderbilt.edu

6153221198

Study Officials

• Shelagh Mulvaney, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind; The participants and the interventionists will be aware of the treatment assignments, but the data collectors will be blinded to the group assignments to reduce bias in data collection and analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study employs a parallel assignment interventional model, wherein participants are randomly allocated to one of two groups: the intervention group or the control group. The intervention group will receive a comprehensive sedentary behavior (SB) reduction program over 8 weeks, utilizing wearable technology, including Fitbit devices and smart water bottles, combined with personalized text message prompts. The control group will receive standard care, consisting of educational materials provided by the American Heart Association, without additional prompts or interventions. The primary goal is to compare the outcomes between these two groups to assess the feasibility, acceptability, and preliminary efficacy of the SB reduction intervention in reducing SB and improving cardiometabolic health and patient-centered outcomes in individuals with type 2 diabetes.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 13, 2024
• Study Start: June 12, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)