Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04003259
Other study ID # R12099
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2009
Est. completion date December 31, 2013

Study information

Verified date June 2019
Source Tampere University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this study was to examine weight reduction in primary care in obese or overweight subjects with a comorbidity that would benefit from weight loss during 1-year comprehensive lifestyle management programme including medical examinations, personalized dietary and exercise advice, guidance on shopping behaviour and food preparation, and group discussions.


Description:

Obesity is associated with altered glucose and lipid metabolism, and elevated blood pressure (BP) increasing the risk of cardiovascular morbidity and mortality. Obesity-induced complications are increasingly encountered in the health care system and especially in primary care. Thus, there is a growing need for individually tailored weight management programs aiming to permanent lifestyle and dietary changes for the prevention and treatment of obesity-related health hazards.

The study investigated weight reduction during 1-year comprehensive lifestyle programme in 134 obese or overweight subjects (BMI>30, or BMI>25 with a comorbidity including diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea). The participants were recruited from the local diabetes centre and health care providers. The programme aimed at 5-10 % weight reduction utilizing exercise program supervised by personal trainer, advice on diet and on-location shopping behavior by a registered dietician, hands-on cooking classes by a professional chef, examinations by a medical doctor, and group discussions. The efficacy of the program was followed by measuring change in weight, BMI, waist circumference, fat and muscle percentage, visceral fat, and systolic and diastolic BP.

The study protocol has been approved by the ethics committee of the Pirkanmaa Hospital District (R12099).


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date December 31, 2013
Est. primary completion date December 31, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria:

- BMI >30

- BMI>25 with a co-morbidity that would benefit from weight loss (diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea)

Exclusion Criteria:

- physical condition that prevented exercise

- abuse of alcohol or drugs

- medical history suggesting poor adherence

- severe concurrent disease

- moderate to severe dementia

Study Design


Intervention

Behavioral:
Lifestyle management programme
The programme consisted of 1) the initiation phase (1-3 months), 2) the establishment phase (3-6 months), and 3) the maintenance phase (7-12 months). Guidance was given altogether on 25 separate occasions with special emphasis on the motivation and education. The goal for weight loss was 5-10 %. The programme included four visits by medical doctor, an educational lecture by medical doctor and personal trainer, five sessions by registered dietician, two cooking classes by professional chef, two group discussions, and exercise as follows: personalized exercise program tailored by personal trainer, one-year gym access with four guided group sessions, and two guided group Nordic walking sessions, and three individual exercise sessions by personal trainer.

Locations

Country Name City State
Finland Tampere University Hospital Tampere Southern Finland

Sponsors (3)

Lead Sponsor Collaborator
Tampere University Sitra, the Finnish Innovation Fund, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in weight (kg) Weight was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months. baseline, and months 2-3, 5-6, and 11-12
Primary Change in body mass index (BMI) (kg/m^2) BMI was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months. baseline, and months 2-3, 5-6, and 11-12
Primary Change in waist circumference (cm) Waist circumference was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months. baseline, and months 2-3, 5-6, and 11-12
Primary Change in muscle mass and body fat (percentage points) Muscle and fat percentage were measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months. baseline, and months 2-3, 5-6, and 11-12
Primary Change in systolic and diastolic blood pressure (mmHg) Blood pressure was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months. baseline, and months 2-3, 5-6, and 11-12
Secondary Fitness index Fitness index was constructed from a two-kilometer walk test with heart rate monitoring and took into consideration age, gender, height, weight, walking time, and heart rate. All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A