Clinical trial NCT04003259: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Hypertension
Dyslipidemias
Diabetes
Keywords: Diet
Exercise
Lifestyle
Weight control
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Sitra, the Finnish Innovation Fund
First posted: 2019-07-01
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in weight (kg)
timeFrame: baseline, and months 2-3, 5-6, and 11-12
measure: Change in body mass index (BMI) (kg/m^2)
timeFrame: baseline, and months 2-3, 5-6, and 11-12
measure: Change in waist circumference (cm)
timeFrame: baseline, and months 2-3, 5-6, and 11-12
measure: Change in muscle mass and body fat (percentage points)
timeFrame: baseline, and months 2-3, 5-6, and 11-12
measure: Change in systolic and diastolic blood pressure (mmHg)
timeFrame: baseline, and months 2-3, 5-6, and 11-12
Secondary outcomes:
measure: Fitness index
timeFrame: All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Southern Finland
Study officials:
affiliation: Tampere University
name: Ilkka Pörsti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.