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出境医 / 临床实验 / Get-a-Grip Lifestyle Management Programme

Get-a-Grip Lifestyle Management Programme

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Hypertension Dyslipidemias Diabetes Behavioral: Lifestyle management programme Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprehensive Lifestyle Management Programme in the Treatment of Obesity: the Get-a-Grip (GAG) Study
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : December 31, 2013
Arms and Interventions
Arm Intervention/treatment
Experimental: Overweight and obese subjects
1-year lifestyle programme
 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.
Outcome Measures
Primary Outcome Measures :
  1. Change in weight (kg) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    Weight was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

  2. Change in body mass index (BMI) (kg/m^2) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    BMI was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

  3. Change in waist circumference (cm) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    Waist circumference was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

  4. Change in muscle mass and body fat (percentage points) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    Muscle and fat percentage were measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

  5. Change in systolic and diastolic blood pressure (mmHg) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    Blood pressure was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.


Secondary Outcome Measures :
  1. Fitness index [ Time Frame: All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12 ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Finland
Tampere University Hospital
Tampere, Southern Finland, Finland, 33521
Sponsors and Collaborators
Tampere University
Tampere University Hospital
Sitra, the Finnish Innovation Fund
Investigators
Layout table for investigator information
Principal Investigator: Ilkka Pörsti, MD, PhD Tampere University
Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date July 1, 2019
Actual Study Start Date  ICMJE January 1, 2009
Actual Primary Completion Date December 31, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Change in weight (kg) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    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) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    BMI was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
  • Change in waist circumference (cm) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    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) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    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) [ Time Frame: baseline, and months 2-3, 5-6, and 11-12 ]
    Blood pressure was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		Fitness index [ Time Frame: All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12 ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Get-a-Grip Lifestyle Management Programme
Official Title  ICMJE Comprehensive Lifestyle Management Programme in the Treatment of Obesity: the Get-a-Grip (GAG) Study
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight and Obesity
  • Hypertension
  • Dyslipidemias
  • Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Overweight and obese subjects
1-year lifestyle programme
Intervention: Behavioral: Lifestyle management programme
Publications * Taurio J, Järvinen J, Hautaniemi EJ, Eräranta A, Viitala J, Nordhausen K, Kaukinen K, Mustonen J, Pörsti 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2019) 		134
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2013
Actual Primary Completion Date December 31, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003259
Other Study ID Numbers  ICMJE R12099
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Ilkka Pörsti, MD, Tampere University
Study Sponsor  ICMJE Tampere University
Collaborators  ICMJE
  • Tampere University Hospital
  • Sitra, the Finnish Innovation Fund
Investigators  ICMJE
Principal Investigator: Ilkka Pörsti, MD, PhD Tampere University
PRS Account Tampere University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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