NCT02374788

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable type-2-diabetes

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

Study Start

First participant enrolled

November 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

6.3 years

First QC Date

January 28, 2015

Last Update Submit

March 9, 2020

Conditions

Type 2 DiabetesPrediabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c (mmol/mol)

    Haemoglobin A1c

    up to month 24.

Secondary Outcomes (21)

  • fasting plasma glucose (mmol/L)

    week 0, 12, 24, and month 9, 12, 18 and 24.

  • Physical activity level (counts/min)

    week 0 and month 6, 12, 18, 24

  • Steps/day

    week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24.

  • fasting-Insulin (mU/l)

    week 0, 12, 24, and month 12 and 24.

  • LDL (mmol/L)

    week 0, 12, 24, and month 12 and 24.

  • +16 more secondary outcomes

Other Outcomes (12)

  • Change in Dietary habits

    Evaluation is conducted at baseline and at week 8, 12, 24 and month 12 and 24 after completion of the intervention period

  • Change in Alcohol habits

    Evaluation is conducted at baseline and at week 24 and month 12 and 24 after completion of the intervention period

  • Change in Stress and working condition

    Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period

  • +9 more other outcomes

Study Arms (3)

Group A

EXPERIMENTAL

Participants in the intensive intervention group (A) receive a pedometer intervention and 12 group meetings over two years' time, with the majority of meetings being held in the first 6 months. The group meetings constitutes of a 30 min walk and 60 min group consulting based on techniques for behaviour change using an interactive program with positive feed-back following their steps on a website. One occasion is taking place at a gym with instruction for a home-based strength training program. Participants receive 10 individual consultations with a diabetes specialist nurse.

Behavioral: Pedometer interventionBehavioral: Group meetingsBehavioral: Individual consultations

Group B

EXPERIMENTAL

Participants in the pedometer group (B) receive a pedometer intervention. Henceforth they are left to continue by they own for two years.

Behavioral: Pedometer intervention

Group C

NO INTERVENTION

The control group (C) receive diabetes care as usual except for the extra measurements included in the study. Diabetes care as usual is meeting a diabetes specialist nurse and a general practitioner once a year receiving lifestyle advice and physical activity on prescription.

Interventions

Pedometer interventionBEHAVIORAL

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

Group AGroup B
Group meetingsBEHAVIORAL

Participants receive 12 group meetings over two years' time.

Group A
Individual consultationsBEHAVIORAL

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.

Group A

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to communicate in Swedish Age 40-80 years Type 2 diabetes: Diagnosed type 2 diabetes with a duration of \>=1 year Pre-diabetes: HbA1c \>39-\<47, Fasting plasma glucose \>5.6 mmol/l

You may not qualify if:

  • Myocardial infarction in the past 6 months
  • serum creatinine \>140
  • diabetic ulcer or risk for ulcer
  • prescribed insulin in past 6 months
  • additional disease prohibiting physical activity
  • have experienced repeated hypoglycaemia or severe hypoglycaemia in past 12 months
  • classified in very hard-intensity activity according to Stanford Brief Activity Survey
  • having no access to internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sophiahemmet University

Stockholm, 114 86, Sweden

Location

Related Publications (6)

  • Rossen J, Yngve A, Hagstromer M, Brismar K, Ainsworth BE, Iskull C, Moller P, Johansson UB. Physical activity promotion in the primary care setting in pre- and type 2 diabetes - the Sophia step study, an RCT. BMC Public Health. 2015 Jul 12;15:647. doi: 10.1186/s12889-015-1941-9.

    PMID: 26164092BACKGROUND

  • Larsson K, Von Rosen P, Rossen J, Johansson UB, Hagstromer M. Relative time in physical activity and sedentary behaviour across a 2-year pedometer-based intervention in people with prediabetes or type 2 diabetes: a secondary analysis of a randomised controlled trial. J Act Sedentary Sleep Behav. 2023 Jun 1;2(1):10. doi: 10.1186/s44167-023-00020-w.

    PMID: 40217375DERIVED

  • Larsson K, Rossen J, Norman A, Johansson UB, Hagstromer M. Predictors associated with an increase in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention. BMC Public Health. 2024 May 11;24(1):1290. doi: 10.1186/s12889-024-18766-6.

    PMID: 38734659DERIVED

  • Rossen J, Larsson K, Hagstromer M, Yngve A, Brismar K, Ainsworth B, Aberg L, Johansson UB. Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes-the Sophia Step Study. Int J Behav Nutr Phys Act. 2021 Sep 8;18(1):121. doi: 10.1186/s12966-021-01193-w.

    PMID: 34496859DERIVED

  • Rossen J, Hagstromer M, Yngve A, Brismar K, Ainsworth B, Johansson UB. Process evaluation of the Sophia Step Study- a primary care based three-armed randomized controlled trial using self-monitoring of steps with and without counseling in prediabetes and type 2 diabetes. BMC Public Health. 2021 Jun 22;21(1):1191. doi: 10.1186/s12889-021-11222-9.

    PMID: 34157994DERIVED

  • Rossen J, Von Rosen P, Johansson UB, Brismar K, Hagstromer M. Associations of physical activity and sedentary behavior with cardiometabolic biomarkers in prediabetes and type 2 diabetes: a compositional data analysis. Phys Sportsmed. 2020 May;48(2):222-228. doi: 10.1080/00913847.2019.1684811. Epub 2019 Nov 12.

    PMID: 31663410DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Unn-Britt Johansson, Professor

    Sophiahemmet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Unn-Britt Johansson

Study Record Dates

First Submitted

January 28, 2015

First Posted

March 2, 2015

Study Start

November 1, 2013

Primary Completion

February 17, 2020

Study Completion

February 17, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)