Get-a-Grip Lifestyle Management Programme

June 28, 2019 updated by: Ilkka Pörsti, MD, Tampere University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Southern Finland
      • Tampere, Southern Finland, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, and months 2-3, 5-6, and 11-12
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.
baseline, and months 2-3, 5-6, and 11-12
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.
baseline, and months 2-3, 5-6, and 11-12
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.
baseline, and months 2-3, 5-6, and 11-12
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.
baseline, and months 2-3, 5-6, and 11-12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University

Collaborators

Tampere University Hospital
Sitra, the Finnish Innovation Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

December 31, 2013

Study Completion (ACTUAL)

December 31, 2013

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (ACTUAL)

July 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R12099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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