Light Intensity Physical Activity Trial

Summary

In type 2 diabetes (T2D), physical activity is an important modifiable risk factor of cardiovascular disease (CVD). Unfortunately (long-term) compliance to exercise programs in patients with T2D is poor. Light-intensity physical activity (LiPA) such as walking slowly, household activities or taking a flight of stairs might be a potential target for lowering the CVD risk in patients with T2D since it can perhaps be more be incorporated into daily life. To assess cardiovascular disease risk in this single-blinded RCT, the investigators settled on measuring arterial stiffness as the primary outcome. Arterial stiffness has independent predictive value for cardiovascular events and can be measured reliably and non-invasively. The investigators hypothesize that light intensity physical activity intervention program based upon increasing LiPA by replacing sedentary time is effective in lowering arterial stiffness as estimated by aortic pulse wave velocity (PWV) and carotid distensibility in individuals with T2D.

Conditions

• Diabetes Mellitus
• Physical Exercise
• Light Intensity Physical Activity
• Arterial Stiffness
• Aortic Stiffness
• Pulse Wave Velocity
• Type2 Diabetes
• Sedentary Lifestyle
• Artery Disease
• Physical Activity

Interventions

BEHAVIORAL

Workshops control group LiPAT

During the first 6 months of the study (the intervention period) participants in the control group will attend 4 workshops in which the benefits of physical activity and the health-risks of sedentary behavior will be discussed. Additionally, information will be provided on healthy lifestyle for patients with type 2 diabetes.

BEHAVIORAL

Interactive workshops LiPAT intervention group

Workshops include practical behavior change strategies and address barriers to movement, awareness of the immediate benefits of movement and implementation-intentions. Participants will be encouraged to cultivate a learning mind-set in order to better tolerate potential set-backs and to apply strategies such as pre-planning their week to incorporate physical activity, engaging their social network, and setting up systems and habits. Participants' progress in changing their physical activity patterns which will be compared and discussed.

DEVICE

Wrist-worn feedback physical activity monitor

Participants receive the feedback monitor (Fitbit inspire®; commercially available consumer product (https://www.fitbit.com/inspire)

DEVICE

Smartphone application LiPAT

With a cloud-based platform the iHealth data is synchronized with a mobile phone app developed by the research team. The app is designed to help the participant to self-monitor their physical activity levels and includes information on total activity and number of steps taken.

BEHAVIORAL

Telephone Coaching

participants in the intervention group will receive telephone coaching during the first 3 months of the intervention. Telephone coaching will be conducted twice in the first month and once each in months two and three. The researcher will enquire about the progress with increasing LiPA, about the experiences of applying the strategies discussed during workshops, and about the experience with Fitbit Inspire® and the corresponding app. If needed, the coach will offer suggestions to improve goal adherence.

Sponsors & Collaborators

• European Foundation for the Study of Diabetes

  collaborator OTHER

• Academisch Ziekenhuis Maastricht

  lead OTHER

Principal Investigators

• Coen D Stehouwer, MD, PhD · Academisch Ziekenhuis Maastricht

• Annemarie Koster, PhD · Maastricht University

• Ronald M Henry, MD, PhD · Academisch Ziekenhuis Maastricht

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-08

Primary Completion

2021-12-31

Completion

2022-02-15

Countries

• Netherlands

Study Locations