Overweight and ObesityNCT04003259
Get-a-Grip Lifestyle Management Programme
A study testing Lifestyle management programme in people with Overweight and Obesity and Hypertension, run by Tampere University at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Overweight and Obesity, Hypertension, Dyslipidemias
- What is being tested?
- Lifestyle management programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2009to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >30
- BMI>25 with a co-morbidity that would benefit from weight loss (diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea)
Who cannot join
- physical condition that prevented exercise
- abuse of alcohol or drugs
- medical history suggesting poor adherence
- severe concurrent disease
- moderate to severe dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Overweight and Obesity, Hypertension, Dyslipidemias, Diabetes
- Being tested
- Lifestyle management programme
- Keywords
- Diet, Exercise, Lifestyle, Weight control
- Medical subject headings
- Overweight, Obesity, Hypertension, Dyslipidemias, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle management programmeBehavioural
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 group | Role | What they receive |
|---|---|---|
| Overweight and obese subjects | Experimental | 1-year lifestyle programme Receives: Behavioral: Lifestyle management programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight (kg)
Weight was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, and months 2-3, 5-6, and 11-12
Secondary outcomes (1)
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.
Measured: All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jan 2009
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Sitra, the Finnish Innovation Fund
- Responsible party
- Principal investigator, Ilkka Pörsti, MD, Tampere University
- Investigators
- Ilkka Pörsti, MD, PhD, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003259
- Sponsor's protocol ID
- R12099
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32461881
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Lifestyle Management Programme in the Treatment of Obesity: the Get-a-Grip (GAG) Study
- ClinicalTrials.gov ID
- NCT04003259
- Acronym / sponsor ID
- R12099
- Conditions
- Overweight and Obesity, Hypertension, Dyslipidemias, Diabetes
- Keywords
- Diet, Exercise, Lifestyle, Weight control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Sitra, the Finnish Innovation Fund
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight and obese subjects | Experimental | Behavioral: Lifestyle management programme1-year lifestyle programme |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >30
- BMI>25 with a co-morbidity that would benefit from weight loss (diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea)
Key exclusion criteria (5 listed)
- physical condition that prevented exercise
- abuse of alcohol or drugs
- medical history suggesting poor adherence
- severe concurrent disease
- moderate to severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle management programmeThe 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. | Behavioural | Overweight and obese subjects |
Primary outcome
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.
1 secondary outcome
Fitness index
Time frame: All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Derived from this study: PubMed 32461881Taurio 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilkka Pörsti, MD, PhD principal investigator
Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle management programme in people with Overweight and Obesity and Hypertension, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (kg) (time frame: baseline, and months 2-3, 5-6, and 11-12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.