ObesityLILANCT03861754
Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
A study testing Lifestyle modification in people with Obesity and Weight Loss, run by University of Oulu at 1 site in Finland.
Trial summary
Objective To study if exercise added to weight loss treatment at the beginning of the weight loss intervention or at 6 months could sustain the weight loss achieved or give extra boost for weight reduction. Design 36-month, 4-group parallel, randomized trial. Setting Oulu, Finland. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity, Weight Loss, Physical Activity
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 28 Jan 2004to May 2010
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass Index > 30
- Age 18-64
Who cannot join
- Pregnancy
- Health reasons preventing exercise and exercise test
- Medication preventing exercise and exercise test
- Previously diagnosed diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Objective To study if exercise added to weight loss treatment at the beginning of the weight loss intervention or at 6 months could sustain the weight loss achieved or give extra boost for weight reduction.
Design 36-month, 4-group parallel, randomized trial.
Read more
Setting Oulu, Finland.
Participants 120 obese adults (body mass index ≥ 30).
Intervention Participants were randomly assigned to behavioural modification (iBM) (n = 30), behavioural modification + exercise from 0 to 3 months (CWT1) (n = 30), behavioural modification + exercise from 6 to 9 months (CWT2) (n = 30), and a control group (CON) (n = 30). Questionnaires and measurements were performed at baseline, 3,9,4 and 36 months. The intervention consisted of an intensified weight loss period (1-12 months) followed by a weight maintenance period (13-36 months). Intensified behavioural modification included 14 individual face to face meetings, eleven times with a personal therapist (qualified nurse) and three times with a nutritionist. Weight maintenance period included six individual meetings with personal therapist. Twelve weeks supervised exercise was offered three times a week, 40 minutes at a time. In the CWT1 group supervised exercise was offered at months 1-3 and in the CWT2 group at months 4-6.
Measurements Body weight (primary outcome) and waist circumference (secondary outcome)
- Being tested
- Lifestyle modification
- Keywords
- Obesity, Weight loss, Weight maintenance, Physical activity, Fitness
- Medical subject headings
- Obesity, Weight Loss, Motor Activity, Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
Also called Lifestyle modification and exercise 1, Lifestyle modification and exercise 2
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Experimental | intensified Behavioural Modification (iBM) group receiving lifestyle counselling Receives: Behavioral: Lifestyle modification |
| Lifestyle modification and exercise 1 | Experimental | Intensified Behavioural Modification and exercise from 0 to 3 months (CWT1) group:
Lifestyle counselling 3 months Exercise intervention from 0 to 3 months Receives: Behavioral: Lifestyle modification |
| Lifestyle modification and exercise 2 | Experimental | Intensified Behavioural Modification and exercise from 6 to 9 months (CWT2) group:
Lifestyle counselling 3 months Exercise intervention from 6 to 9 months Receives: Behavioral: Lifestyle modification |
| Control Group | No intervention | Control group, no intervention, only measurements and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Kilograms
Measured: Change from baseline weight at 36 months
Secondary outcomes (1)
Waist circumference change
Cm
Measured: Change from baseline waist circumference at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start28 Jan 2004
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu Deaconess Institute Foundation sr, Oulu University Hospital
- Responsible party
- Principal investigator, Kaisu Kaikkonen, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861754
- Sponsor's protocol ID
- 147/2006
- Acronym
- LILA
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity on Weight Loss and Weight Maintenance in Obese Adults - Three Year Follow-up Study
- ClinicalTrials.gov ID
- NCT03861754
- Acronym / sponsor ID
- LILA / 147/2006
- Keywords
- Obesity, Weight loss, Weight maintenance, Physical activity, Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu Deaconess Institute Foundation sr, Oulu University Hospital
- Study start
- 28 Jan 2004 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 4 Mar 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.
Objective To study if exercise added to weight loss treatment at the beginning of the weight loss intervention or at 6 months could sustain the weight loss achieved or give extra boost for weight reduction.
Design 36-month, 4-group parallel, randomized trial.
Setting Oulu, Finland.
Participants 120 obese adults (body mass index ≥ 30).
Intervention Participants were randomly assigned to behavioural modification (iBM) (n = 30), behavioural modification + exercise from 0 to 3 months (CWT1) (n = 30), behavioural modification + exercise from 6 to 9 months (CWT2) (n = 30), and a control group (CON) (n = 30). Questionnaires and measurements were performed at baseline, 3,9,4 and 36 months. The intervention consisted of an intensified weight loss period (1-12 months) followed by a weight maintenance period (13-36 months). Intensified behavioural modification included 14 individual face to face meetings, eleven times with a personal therapist (qualified nurse) and three times with a nutritionist. Weight maintenance period included six individual meetings with personal therapist. Twelve weeks supervised exercise was offered three times a week, 40 minutes at a time. In the CWT1 group supervised exercise was offered at months 1-3 and in the CWT2 group at months 4-6.
Measurements Body weight (primary outcome) and waist circumference (secondary outcome)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Experimental | Behavioral: Lifestyle modificationintensified Behavioural Modification (iBM) group receiving lifestyle counselling |
| Lifestyle modification and exercise 1 | Experimental | Behavioral: Lifestyle modificationIntensified Behavioural Modification and exercise from 0 to 3 months (CWT1) group: Lifestyle counselling 3 months Exercise intervention from 0 to 3 months |
| Lifestyle modification and exercise 2 | Experimental | Behavioral: Lifestyle modificationIntensified Behavioural Modification and exercise from 6 to 9 months (CWT2) group: Lifestyle counselling 3 months Exercise intervention from 6 to 9 months |
| Control Group | No intervention | –Control group, no intervention, only measurements and questionnaires |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass Index > 30
- Age 18-64
Key exclusion criteria (4 listed)
- Pregnancy
- Health reasons preventing exercise and exercise test
- Medication preventing exercise and exercise test
- Previously diagnosed diabetes
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 modificationAlso: Lifestyle modification and exercise 1, Lifestyle modification and exercise 2 | Behavioural | Lifestyle modification, Lifestyle modification and exercise 1, Lifestyle modification and exercise 2 |
Primary outcome
Weight change
Time frame: Change from baseline weight at 36 months
Kilograms
1 secondary outcome
Waist circumference change
Time frame: Change from baseline waist circumference at 36 months
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 4 Mar 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 modification in people with Obesity and Weight Loss, run by University of Oulu 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 4 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 4 Mar 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?
Weight change (time frame: Change from baseline weight at 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2019.