Get-a-Grip Lifestyle Management Programme

Hypertension Clinical Trial

Official title:

Comprehensive Lifestyle Management Programme in the Treatment of Obesity: the Get-a-Grip (GAG) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003259
• Other study ID #: R12099
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes
• Dyslipidemias
• Hypertension
• Obesity
• Overweight
• Overweight and Obesity

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