Get-a-Grip Lifestyle Management Programme

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Overweight and Obesity, Hypertension, Dyslipidemias, Diabetes

Intervention / Treatment
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* Behavioral: Lifestyle management programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overweight and obese subjects<br>1-year lifestyle programme | Behavioral: Lifestyle management programme<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Exercise, Lifestyle, Weight control