Sit Less Program for Patients With Type 2 Diabetes

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2024-08-20

Brief Summary

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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.

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Detailed Description

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The investigators propose to develop and conduct a pilot randomized controlled trial to test a wearable technology-based sedentary behavior (SB) reduction intervention in type 2 diabetes (T2D) patients. The study will recruit 80 participants who will be randomized to either the control group or the intervention group. The 8-week intervention aims to reduce daily SB by at least 120 minutes through the use of Fitbit devices, a smart water bottle, and tailored text messages. Participants will set personalized SB reduction goals and receive prompts to stand or walk, along with hydration reminders from the smart water bottle to encourage movement.

Specifically, the study aims to: determine the acceptability of the SB reduction intervention in T2D patients by evaluating satisfaction and compliance; evaluate the preliminary efficacy of the intervention on reducing total SB time and numbers of prolonged SB bouts; and explore preliminary effects on light physical activity, cardiometabolic markers (24-hour glycemic control, BMI, waist circumference, blood pressure), and patient-centered outcomes (confidence in reducing SB, habit strength for SB, and quality of life). Outcomes will be measured at baseline and post-intervention using biometric assessments, questionnaires, and continuous glucose monitoring. The study seeks to provide insights into the feasibility and potential health benefits of a technology-driven SB reduction program for T2D patients.

Conditions

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Type 2 Diabetes Sedentary Behavior Sedentary Time Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Sit Less Group - mHealth intervention

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.

Group Type EXPERIMENTAL

Sit Less Program

Intervention Type 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.

Control Group - Standard Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sit Less Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No