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Clinical Trials/NCT04003259
NCT04003259CompletedNot Applicable

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

Tampere University1 site in 1 country134 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
134
Locations
1
Primary Endpoint
Change in weight (kg)

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 69 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

Overweight and obese subjects

Experimental

1-year lifestyle programme

Intervention: Lifestyle management programme (Behavioral)

Outcomes

Primary Outcomes

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 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 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 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.

Secondary Outcomes

  • Fitness index(All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ilkka Pörsti, MD

Clinical Professor

Tampere University

Study Sites (1)

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