Get-a-Grip Lifestyle Management Programme
Primary Purpose
Overweight and Obesity, Hypertension, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lifestyle management programme
Sponsored by

About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Diet, Exercise, Lifestyle, Weight control
Eligibility Criteria
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
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Overweight and obese subjects
Arm Description
1-year lifestyle programme
Outcomes
Primary Outcome Measures
Change in weight (kg)
Weight was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
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.
Change in waist circumference (cm)
Waist circumference was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04003259
First Posted
June 25, 2019
Last Updated
June 28, 2019
Sponsor
Tampere University
Collaborators
Tampere University Hospital, Sitra, the Finnish Innovation Fund
1. Study Identification
Unique Protocol Identification Number
NCT04003259
Brief Title
Get-a-Grip Lifestyle Management Programme
Official Title
Comprehensive Lifestyle Management Programme in the Treatment of Obesity: the Get-a-Grip (GAG) Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
December 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Tampere University Hospital, Sitra, the Finnish Innovation Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Hypertension, Dyslipidemias, Diabetes
Keywords
Diet, Exercise, Lifestyle, Weight control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Overweight and obese subjects
Arm Type
Experimental
Arm Description
1-year lifestyle programme
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle management programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in weight (kg)
Description
Weight was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
Time Frame
baseline, and months 2-3, 5-6, and 11-12
Title
Change in body mass index (BMI) (kg/m^2)
Description
BMI was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
Time Frame
baseline, and months 2-3, 5-6, and 11-12
Title
Change in waist circumference (cm)
Description
Waist circumference was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
Time Frame
baseline, and months 2-3, 5-6, and 11-12
Title
Change in muscle mass and body fat (percentage points)
Description
Muscle and fat percentage were measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
Time Frame
baseline, and months 2-3, 5-6, and 11-12
Title
Change in systolic and diastolic blood pressure (mmHg)
Description
Blood pressure was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
Time Frame
baseline, and months 2-3, 5-6, and 11-12
Secondary Outcome Measure Information:
Title
Fitness index
Description
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.
Time Frame
All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilkka Pörsti, MD, PhD
Organizational Affiliation
Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Southern Finland
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Analyses and generated datasets during the current study are not available publicly as the informed consent obtained does not allow publication of individual patient data. However, raw data is available from the principal investigator (email ilkka.porsti@tuni.fi) on reasonable request.
Citations:
PubMed Identifier
32461881
Citation
Taurio J, Jarvinen J, Hautaniemi EJ, Eraranta A, Viitala J, Nordhausen K, Kaukinen K, Mustonen J, Porsti IH. Team-based "Get-a-Grip" lifestyle management programme in the treatment of obesity. Prev Med Rep. 2020 May 13;19:101119. doi: 10.1016/j.pmedr.2020.101119. eCollection 2020 Sep.
Results Reference
derived
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Get-a-Grip Lifestyle Management Programme
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