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Sophia Step Study - a Behaviour Change Program on Physical Activity in Persons With Pre- and Type 2 Diabetes

NCT02374788 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2020-03-10

No results posted yet for this study

Summary

The aim of the study is to investigate the effects of two levels of primary care physical activity interventions on metabolic control and cardiovascular risk factors, compared to usual care in patients with pre- and type 2 diabetes.

The hypothesis is that both levels of interventions have effect on HbA1c with the more intense Group intervention having superior effects.

Conditions

Interventions

BEHAVIORAL

Pedometer intervention

Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.

BEHAVIORAL

Group meetings

Participants receive 12 group meetings over two years' time.

BEHAVIORAL

Individual consultations

Participants receive 10 individual meetings with a diabetes specialist nurse. Physical activity on prescription is used to set individual goals and to highlight the importance of physical activity.

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Uppsala University

    collaborator OTHER

  • Arizona State University

    collaborator OTHER

  • Sophiahemmet University

    lead OTHER

Principal Investigators

  • Unn-Britt Johansson, Professor · Sophiahemmet University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2020-02-17
Completion
2020-02-17

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374788 on ClinicalTrials.gov