ObesityNCT04425304
Effects of Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
A study testing Group counseling, Intensive group counseling and Persuasive ICT support in people with Obesity, run by University of Oulu at 1 site in Finland.
Trial summary
The aim of the trial is to study the effect of a lifestyle change program in patients with obesity and risk of cardiovascular diseases. The main focus is to motivate and support lifestyle changes. Two different group counseling methods (intensive and standard) with or without internet support will be compared. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Group counseling, Intensive group counseling and Persuasive ICT support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 2 Jun 2020to 23 May 2024
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index 30 to 40 kg/m2
- + 2 risk factors of cardiovascular diseases:
- Elevated blood pressure or hypertension
- High LDL or hypocholesterolemic drug
- Low HDL or hypocholesterolemic drug
- Elevated triglyceride value or hypolipidemic drug
Show all 9Show fewer
- Elevated glucose value or diabetes medication
- Smoking
- Access to email and internet
Who cannot join
- Untreated hypothyroidism
- Oral corticosteroid treatment
- Pregnancy and lactation
- Angina pectoris
- Cardiac insufficiency
- Coronary Heart Disease
- Inability to speak Finnish
- Anticipated lack of compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
The aim of the trial is to study the effect of a lifestyle change program in patients with obesity and risk of cardiovascular diseases. The main focus is to motivate and support lifestyle changes.
Two different group counseling methods (intensive and standard) with or without internet support will be compared. Thus, the patients will be randomized into four arms. Patients will be recruited from local general practice teams. The intensive lifestyle counseling consists of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling consists of 4 group sessions. The internet-based counseling contains aspects of cognitive behavior therapy and persuasive design system and consists of weekly reminders, tasks, self-monitoring, and reflection.
The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk and adiposity.
- Conditions
- Obesity
- Being tested
- Group counseling, Intensive group counseling, Persuasive ICT support
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group counselingBehavioural
4 times
Intensive group counselingBehavioural
14 times
Persuasive ICT supportBehavioural
Weekly reminders for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Group counseling | Active comparator | Not described Receives: Behavioral: Group counseling |
| Group counseling + persuasive ICT support | Experimental | Not described Receives: Behavioral: Group counseling; Behavioral: Persuasive ICT support |
| Intensive group counseling | Active comparator | Not described Receives: Behavioral: Intensive group counseling |
| Intensive group counseling + persuasive ICT support | Experimental | Not described Receives: Behavioral: Intensive group counseling; Behavioral: Persuasive ICT support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start2 Jun 2020
- Primary completion23 May 2024
- Study completion23 May 2024
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janne Hukkanen, University of Oulu
- Investigators
- Janne Hukkanen, MD, PhD, Principal investigator, University of Oulu, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425304
- Sponsor's protocol ID
- Resepti-Onnikka
- Status last verified
- Dec 2024
- First submitted
- 6 Jun 2020
- Last updated
- 11 Dec 2024
- 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 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
- ClinicalTrials.gov ID
- NCT04425304
- Acronym / sponsor ID
- Resepti-Onnikka
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 11 Jun 2020 (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 aim of the trial is to study the effect of a lifestyle change program in patients with obesity and risk of cardiovascular diseases. The main focus is to motivate and support lifestyle changes.
Two different group counseling methods (intensive and standard) with or without internet support will be compared. Thus, the patients will be randomized into four arms. Patients will be recruited from local general practice teams. The intensive lifestyle counseling consists of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling consists of 4 group sessions. The internet-based counseling contains aspects of cognitive behavior therapy and persuasive design system and consists of weekly reminders, tasks, self-monitoring, and reflection.
The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk and adiposity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group counseling | Active comparator | Behavioral: Group counseling |
| Group counseling + persuasive ICT support | Experimental | Behavioral: Group counseling, Behavioral: Persuasive ICT support |
| Intensive group counseling | Active comparator | Behavioral: Intensive group counseling |
| Intensive group counseling + persuasive ICT support | Experimental | Behavioral: Intensive group counseling, Behavioral: Persuasive ICT support |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body mass index 30 to 40 kg/m2
- + 2 risk factors of cardiovascular diseases:
- Access to email and internet
Key exclusion criteria (8 listed)
- Untreated hypothyroidism
- Oral corticosteroid treatment
- Pregnancy and lactation
- Angina pectoris
- Cardiac insufficiency
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 |
|---|---|---|
| Group counseling4 times | Behavioural | Group counseling, Group counseling + persuasive ICT support |
| Intensive group counseling14 times | Behavioural | Intensive group counseling, Intensive group counseling + persuasive ICT support |
| Persuasive ICT supportWeekly reminders for 12 months | Behavioural | Group counseling + persuasive ICT support, Intensive group counseling + persuasive ICT support |
Primary outcome
Change in body weight
Time frame: Baseline to 2 years
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 11 Dec 2024.
- 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.
Janne Hukkanen, MD, PhD principal investigator
University of Oulu, Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group counseling, Intensive group counseling and Persuasive ICT support in people with Obesity, 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 9 inclusion and 8 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 11 Dec 2024. 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 body weight (time frame: Baseline to 2 years). 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 11 Dec 2024.