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Completed

NCT Number: NCT02374788

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sophiahemmet University

Stockholm, 114 86, Sweden

About this study

Regularly physical activity may decrease the risk for type 2 diabetes, cardiovascular diseases, overweight and premature deaths. Despite the evidence that physical activity is beneficial to health,it is often ignored and underused aspect in diabetes care. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Pedometer Intervention

Behavioral

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

Group meetings

Behavioral

Participants receive 12 group meetings over two years' time.

Individual consultations

Behavioral

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.

Primary outcomes

  1. HbA1c (mmol/mol)

    Time frame: up to month 24.

    Haemoglobin A1c

Secondary outcomes

  1. fasting plasma glucose (mmol/L)

    Time frame: week 0, 12, 24, and month 9, 12, 18 and 24.

    Determined by a glucose oxidase method

  2. Physical activity level (counts/min)

    Time frame: week 0 and month 6, 12, 18, 24

    Actigraph accelerometer GT1M

  3. Steps/day

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

    Actigraph accelerometer GT1M

  4. fasting-Insulin (mU/l)

    Time frame: week 0, 12, 24, and month 12 and 24.

    Serum insulin concentrations are determined with RIA-kits purchased from Pharmacia & Upjohn, Stockholm.

  5. LDL (mmol/L)

    Time frame: week 0, 12, 24, and month 12 and 24.

    LDL is determined by using a homogeneous method (lowdensity lipoprotein)

  6. Total cholesterol (mmol/L)

    Time frame: week 0, 12, 24, and month 12 and 24.

    total Cholesterol is determined by using enzymatic method

  7. IGF BP1 (μg/L)

    Time frame: week 0, 12, 24, and month 12 and 24.

    insulin-like growth factor binding protein 1

  8. Free fatty acids (mmol(L )

    Time frame: week 0, 12, 24, and month 12 and 24.

    Samples are saved for later free fatty acid analyses.

  9. Triglycerides (mmol/L)

    Time frame: week 0, 12, 24, and month 12, 18 and 24.

    Triglycerides is determined by using enzymatic method (Triglycerides)

  10. HDL (mmol/L)

    Time frame: week 0, 12, 24, and month 12, 18 and 24.

    HDL is determined by using a homogeneous method (lowdensity lipoprotein)(High-density lipoprotein)

  11. ApoB (g/l)

    Time frame: week 0, 24 and month 24.

    Apolipoprotein B is determined by using turbimetric method

  12. ApoA1 (g/l)

    Time frame: week 0, 24 and month 24.

    ApolipoproteinA1 is determined by using turbimetric method

  13. C-peptide (pmol/l)

    Time frame: week 0, 12, 24, and month 12 and 24.

    C-peptid are determined by using immunometric method using two monoclonal antibodies and detection with electrochemiluminiscense using a Modular E system (Beckman Coulter, Inc.).

  14. BMI (kg/m2)

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

    Body mass index

  15. Weight (kg)

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

    Tanita digital scale (Model TBF- 300A, Arlington Heights, IL). Weight is measured with light clothes, no shoes to the nearest 0.1 kg.

  16. % Body Fat

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

    % Body Fat is determined by Tanita digital scale (Model TBF- 300A, Arlington Heights, IL).

  17. Waist circumference (cm)

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

    Waist circumference is measured with SECA 201 tape, horizontal around the waist 2 cm above the umbilicus.

  18. Sagittal Abdominal Diameter (cm)

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

    Sagittal abdominal diameter is measured with the subject in a supine position with the knees expanded at the level of the umbilicus using a Holtain-Kahn abdominal caliper (Holtain, Ltd., Crosswell, Crymych; Dyfed, UK).

  19. Resting blood pressure (mmHg)

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

    diastolic blood pressure and systolic blood pressure. Resting blood pressure is measured with Omron M6 Comfort.

  20. Muscle strength

    Time frame: week 0, 12, 24, and month 9, 12, 18 and 24.

    measured by hand-held dynamometry. Hand grip strength is measured in kilograms using the hand-held Saehan Hydraulic Hand Dynamometer, model SH5001 (former Jamar) (Saehan Corporation, Masan, South Korea).

  21. Change in Smoking and snuffing habits

    Time frame: Evaluation is conducted at baseline and at 24 months after completion of the intervention period

    Change in Smoking and snuffing habits is measured with questions on current and previous habits and the dose

Other outcomes

  1. Change in Dietary habits

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

    Change in Dietary habits is measured by a set of questions developed and validated by The Swedish National Food Agency.

  2. Change in Alcohol habits

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

    Change in Alcohol habits is measured by two questions from AUDIT-The alcohol Use disorders

  3. Change in Stress and working condition

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

    Change in Stress and working condition is measured by four questions

  4. EuroQol (EQ-5D)

    Time frame: week 0, 12, 24 and month 12 and 24

    measured by EQ-5D assess components of health related QoL (HRQoL). EQ-5D includes measures related to mobility, hygiene, daily activities, pain/ discomfort and anxiety/depression.

  5. Sleep

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

    Sleep is measured by two questions. One question on difficulties falling asleep and one question on sleep quality.

  6. Self reported physical activity

    Time frame: week 0, 12, 24 and month 12 and 24

    International Physical Activity Questionnaire (IPAQ) self-reported 7-item questionnaire to assess physical activity.

  7. Self-efficacy for exercise

    Time frame: week 0, 12, 24 and month 12 and 24

    The questionnaire Self-efficacy for exercise is a 5 item questionnaire and assess one´s confidence to continue exercising in different situations.

  8. Physical Activity Social Support (PASS)

    Time frame: week 0, 12, 24 and month 12 and 24

    Physical Activity Social Support (PASS) for exercise 6 items.

  9. Change in Neighborhood Environment

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

    Change in Neighborhood Environment is measured by 17 questions about Walking Environment, Availability of healthy Foods, Safety and Social cohesion

  10. Change in Perceived Stress Scale (PSS)

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

    Change in Perceived Stress is measured by the Perceived Stress Scale (PSS) which is a 14- items questionnaire.

  11. Change in diabetes distress (PAID-20)

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

    Diabetes distress is measured by The Problem Areas in Diabetes questionnaire (Swe-PAID-20): This is a 20 items questionnaire

  12. Hospital Anxiety and Depression Scale (HADS)

    Time frame: week 0, 12, 24 and month 12 and 24

    HADS is a 14 item questionnaire and consists of two subscales depression and anxiety, with seven items each.

Sponsors and collaborators

Lead sponsor

Sophiahemmet University

Other

Collaborators

  • Arizona State University
  • Karolinska Institutet
  • Uppsala University

Registry information

Official study title

Health Promotion in the Primary Care Setting- an Evaluation of the Sophia Step Study- a Structured Behaviour Change Program Focusing on Physical Activity in Persons With Pre- and Type 2 Diabetes

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2015
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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