NCT03415880

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

November 8, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

January 8, 2018

Last Update Submit

January 31, 2023

Conditions

Diabetes MellitusPhysical ExerciseLight Intensity Physical ActivityArterial StiffnessAortic StiffnessPulse Wave VelocityType2 DiabetesSedentary LifestyleArtery DiseasePhysical Activity

Keywords

Diabetes mellitusType2 DiabetesSedentary LifestylePhysical ActivityPulse wave velocityarterial stiffnessaortic stiffnessartery diseaselight intensity physical activity

Outcome Measures

Primary Outcomes (2)

  • The effect of a LiPA intervention program on reducing aortic carotid-to-femoral pulse-wave velocity (PWV) in patients with type 2 diabetes.

    Aortic (carotid to femoral) PWV will be determined by means of applanation tonometry. It will be calculated as the median of three consecutive PWV recordings.

    Change from baseline PWV at 6 months.

  • The effect of a LiPA intervention program on increasing carotid distensibility in patients with type 2 diabetes.

    Carotid distensibility will be determined at the left common carotid by means of arterial ultrasound.

    Change from baseline carotid distensibility at 6 months.

Secondary Outcomes (17)

  • Feasibility of a LiPA intervention program on reducing sedentary time as measured by activPAL

    Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

  • The effect of a LiPA intervention on changes in blood pressure.

    Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

  • The effect of a LiPA intervention on waist -circumference in cm.

    Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

  • The effect of a LiPA intervention on quality of life as measured through the Dutch versions of the EQ-5D questionnaire.

    Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

  • The effect of a LiPA intervention on depressive symptoms with the use a validated Dutch version of the 9-item Patient Health Questionnaire (PHQ-9).

    Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

  • +12 more secondary outcomes

Study Arms (2)

Control group

OTHER

Participants attend 4 workshops and undergo all measurements at t=0, t=3, t=6, and t=12 months.

Behavioral: Workshops control group LiPAT

Intervention group

EXPERIMENTAL

Participants attend 4 workshops, receive a wrist-worn feedback physical activity monitor, a smartphone app, and telephone coaching. All participants undergo all measurements at t=0, t=3, t=6, and t=12 months.

Behavioral: Interactive workshops LiPAT intervention groupDevice: Wrist-worn feedback physical activity monitorDevice: Smartphone application LiPATBehavioral: Telephone Coaching

Interventions

Interactive workshops LiPAT intervention groupBEHAVIORAL

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.

Intervention group
Wrist-worn feedback physical activity monitorDEVICE

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

Intervention group
Smartphone application LiPATDEVICE

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.

Intervention group
Telephone CoachingBEHAVIORAL

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.

Intervention group
Workshops control group LiPATBEHAVIORAL

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.

Control group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • having type 2 diabetes
  • BMI 20-35 kg/m2
  • having a sedentary lifestyle (i.e., self-reported moderate-to-vigorous physical activity \< 150 minutes per week)
  • willingness to undergo randomization
  • being in the possession of personally owned smart phone

You may not qualify if:

  • not being able to walk for 15 minutes for any (medical) reason
  • currently engaged in an (medical) exercise program
  • plan to move out of the study area in the next 12 months
  • (digital) illiteracy or being unable to read Dutch
  • a history or signs or symptoms of COPD (eligible are those participants with a COPD Gold classification ≤ I)
  • uncontrolled diabetes (i.e., uncontrolled hypo- or hyperglycaemia)
  • uncontrolled hypertension (i.e., systolic / diastolic blood pressure ≥ 180 / 95 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Diabetes MellitusMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Coen D Stehouwer, MD, PhD

    Academisch Ziekenhuis Maastricht

    PRINCIPAL INVESTIGATOR

  • Annemarie Koster, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

  • Ronald M Henry, MD, PhD

    Academisch Ziekenhuis Maastricht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator measuring the outcome measures will be blinded to patient allocation. Patients are asked not to mention their allocated group or the programme they follow and not to wear or mention the wrist-worn activity tracker during measurements.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study consists of an intervention group and a control group. Both arms run parallel and both groups are measured at the same time points.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 30, 2018

Study Start

November 8, 2018

Primary Completion

December 31, 2021

Study Completion

February 15, 2022

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

We will be able to share documents upon reasonable request and once the study results have been published.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
We will be able to share documents upon reasonable request and once the study results have been published. The paper with study results is currently in preparation.
Access Criteria
Requests could be addressed to the PI's.

Locations

NL(1)