Clinical trial NCT02374788: Sophia Step Study - a Behaviour Change Program on Physical Activity in Persons With Pre- and Type 2 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Prediabetes
Lead sponsor: Sophiahemmet University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Uppsala University
name: Arizona State University
First posted: 2015-03-02
Enrollment: 188
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c (mmol/mol)
timeFrame: up to month 24.
Secondary outcomes:
measure: fasting plasma glucose (mmol/L)
timeFrame: week 0, 12, 24, and month 9, 12, 18 and 24.
measure: Physical activity level (counts/min)
timeFrame: week 0 and month 6, 12, 18, 24
measure: Steps/day
timeFrame: week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24.
measure: fasting-Insulin (mU/l)
timeFrame: week 0, 12, 24, and month 12 and 24.
measure: LDL (mmol/L)
timeFrame: week 0, 12, 24, and month 12 and 24.
measure: Total cholesterol (mmol/L)
timeFrame: week 0, 12, 24, and month 12 and 24.
measure: IGF BP1 (μg/L)
timeFrame: week 0, 12, 24, and month 12 and 24.
measure: Free fatty acids (mmol(L )
timeFrame: week 0, 12, 24, and month 12 and 24.
measure: Triglycerides (mmol/L)
timeFrame: week 0, 12, 24, and month 12, 18 and 24.
measure: HDL (mmol/L)
timeFrame: week 0, 12, 24, and month 12, 18 and 24.
measure: ApoB (g/l)
timeFrame: week 0, 24 and month 24.
measure: ApoA1 (g/l)
timeFrame: week 0, 24 and month 24.
measure: C-peptide (pmol/l)
timeFrame: week 0, 12, 24, and month 12 and 24.
measure: BMI (kg/m2)
timeFrame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
measure: Weight (kg)
timeFrame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
measure: % Body Fat
timeFrame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
measure: Waist circumference (cm)
timeFrame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
measure: Sagittal Abdominal Diameter (cm)
timeFrame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
measure: Resting blood pressure (mmHg)
timeFrame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
measure: Muscle strength
timeFrame: week 0, 12, 24, and month 9, 12, 18 and 24.
measure: Change in Smoking and snuffing habits
timeFrame: Evaluation is conducted at baseline and at 24 months after completion of the intervention period
Other outcomes:
measure: Change in Dietary habits
timeFrame: Evaluation is conducted at baseline and at week 8, 12, 24 and month 12 and 24 after completion of the intervention period
measure: Change in Alcohol habits
timeFrame: Evaluation is conducted at baseline and at week 24 and month 12 and 24 after completion of the intervention period
measure: Change in Stress and working condition
timeFrame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
measure: EuroQol (EQ-5D)
timeFrame: week 0, 12, 24 and month 12 and 24
measure: Sleep
timeFrame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
measure: Self reported physical activity
timeFrame: week 0, 12, 24 and month 12 and 24
measure: Self-efficacy for exercise
timeFrame: week 0, 12, 24 and month 12 and 24
measure: Physical Activity Social Support (PASS)
timeFrame: week 0, 12, 24 and month 12 and 24
measure: Change in Neighborhood Environment
timeFrame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
measure: Change in diabetes distress (PAID-20)
timeFrame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: week 0, 12, 24 and month 12 and 24
Locations:
city: Stockholm
country: Sweden
facility: Sophiahemmet University
Study officials:
affiliation: Sophiahemmet University
name: Unn-Britt Johansson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.