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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374788
• Other study ID #: SophiahemmetU
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: February 17, 2020

Study information

• Verified date: March 2020
• Source: Sophiahemmet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Prediabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

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.
• Group meetings
Participants receive 12 group meetings over two years' time.
• 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.

Locations

Country	Name	City	State
Sweden	Sophiahemmet University	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Sophiahemmet University	Arizona State University, Karolinska Institutet, Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Rossen J, Yngve A, Hagströmer M, Brismar K, Ainsworth BE, Iskull C, Möller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Dietary habits	Change in Dietary habits is measured by a set of questions developed and validated by The Swedish National Food Agency.	Evaluation is conducted at baseline and at week 8, 12, 24 and month 12 and 24 after completion of the intervention period
Other	Change in Alcohol habits	Change in Alcohol habits is measured by two questions from AUDIT-The alcohol Use disorders	Evaluation is conducted at baseline and at week 24 and month 12 and 24 after completion of the intervention period
Other	Change in Stress and working condition	Change in Stress and working condition is measured by four questions	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Other	EuroQol (EQ-5D)	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.	week 0, 12, 24 and month 12 and 24
Other	Sleep	Sleep is measured by two questions. One question on difficulties falling asleep and one question on sleep quality.	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Other	Self reported physical activity	International Physical Activity Questionnaire (IPAQ) self-reported 7-item questionnaire to assess physical activity.	week 0, 12, 24 and month 12 and 24
Other	Self-efficacy for exercise	The questionnaire Self-efficacy for exercise is a 5 item questionnaire and assess one´s confidence to continue exercising in different situations.	week 0, 12, 24 and month 12 and 24
Other	Physical Activity Social Support (PASS)	Physical Activity Social Support (PASS) for exercise 6 items.	week 0, 12, 24 and month 12 and 24
Other	Change in Neighborhood Environment	Change in Neighborhood Environment is measured by 17 questions about Walking Environment, Availability of healthy Foods, Safety and Social cohesion	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Other	Change in Perceived Stress Scale (PSS)	Change in Perceived Stress is measured by the Perceived Stress Scale (PSS) which is a 14- items questionnaire.	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Other	Change in diabetes distress (PAID-20)	Diabetes distress is measured by The Problem Areas in Diabetes questionnaire (Swe-PAID-20): This is a 20 items questionnaire	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Other	Hospital Anxiety and Depression Scale (HADS)	HADS is a 14 item questionnaire and consists of two subscales depression and anxiety, with seven items each.	week 0, 12, 24 and month 12 and 24
Primary	HbA1c (mmol/mol)	Haemoglobin A1c	up to month 24.
Secondary	fasting plasma glucose (mmol/L)	Determined by a glucose oxidase method	week 0, 12, 24, and month 9, 12, 18 and 24.
Secondary	Physical activity level (counts/min)	Actigraph accelerometer GT1M	week 0 and month 6, 12, 18, 24
Secondary	Steps/day	Actigraph accelerometer GT1M	week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24.
Secondary	fasting-Insulin (mU/l)	Serum insulin concentrations are determined with RIA-kits purchased from Pharmacia & Upjohn, Stockholm.	week 0, 12, 24, and month 12 and 24.
Secondary	LDL (mmol/L)	LDL is determined by using a homogeneous method (lowdensity lipoprotein)	week 0, 12, 24, and month 12 and 24.
Secondary	Total cholesterol (mmol/L)	total Cholesterol is determined by using enzymatic method	week 0, 12, 24, and month 12 and 24.
Secondary	IGF BP1 (µg/L)	insulin-like growth factor binding protein 1	week 0, 12, 24, and month 12 and 24.
Secondary	Free fatty acids (mmol(L )	Samples are saved for later free fatty acid analyses.	week 0, 12, 24, and month 12 and 24.
Secondary	Triglycerides (mmol/L)	Triglycerides is determined by using enzymatic method (Triglycerides)	week 0, 12, 24, and month 12, 18 and 24.
Secondary	HDL (mmol/L)	HDL is determined by using a homogeneous method (lowdensity lipoprotein)(High-density lipoprotein)	week 0, 12, 24, and month 12, 18 and 24.
Secondary	ApoB (g/l)	Apolipoprotein B is determined by using turbimetric method	week 0, 24 and month 24.
Secondary	ApoA1 (g/l)	ApolipoproteinA1 is determined by using turbimetric method	week 0, 24 and month 24.
Secondary	C-peptide (pmol/l)	C-peptid are determined by using immunometric method using two monoclonal antibodies and detection with electrochemiluminiscense using a Modular E system (Beckman Coulter, Inc.).	week 0, 12, 24, and month 12 and 24.
Secondary	BMI (kg/m2)	Body mass index	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Secondary	Weight (kg)	Tanita digital scale (Model TBF- 300A, Arlington Heights, IL). Weight is measured with light clothes, no shoes to the nearest 0.1 kg.	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Secondary	% Body Fat	% Body Fat is determined by Tanita digital scale (Model TBF- 300A, Arlington Heights, IL).	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Secondary	Waist circumference (cm)	Waist circumference is measured with SECA 201 tape, horizontal around the waist 2 cm above the umbilicus.	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Secondary	Sagittal Abdominal Diameter (cm)	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).	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Secondary	Resting blood pressure (mmHg)	diastolic blood pressure and systolic blood pressure. Resting blood pressure is measured with Omron M6 Comfort.	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Secondary	Muscle strength	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).	week 0, 12, 24, and month 9, 12, 18 and 24.
Secondary	Change in Smoking and snuffing habits	Change in Smoking and snuffing habits is measured with questions on current and previous habits and the dose	Evaluation is conducted at baseline and at 24 months after completion of the intervention period

External Links

•   Study protocol