Overweight and ObesityNCT03000062
Treatment of Overweight in General Practice
A study testing Intervention group in people with Overweight and Obesity and Nutritional and Metabolic Diseases, run by University of Oslo.
Trial summary
In this study the investigators want to explore the feasibility and effect of a simple intervention provided by primary care physicians on treatment for overweight in general practice. Regular patients visiting their ordinary family physician will be asked for participation if they comply with the inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Nutritional and Metabolic Diseases
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI _> 30 OR _25 With at least one Medical condition related to overweight (hypertension, dyslipidemia, metabolic syndrome, diabetes mellitus II, hip- or knee pain)
- written consent
- sufficient knowledge in Norwegian Language to acquire the written and oral information
Who cannot join
- any ongoing cancer condition
- any current medication impacting on weight
About this study
In this study the investigators want to explore the feasibility and effect of a simple intervention provided by primary care physicians on treatment for overweight in general practice. Regular patients visiting their ordinary family physician will be asked for participation if they comply with the inclusion criteria. If so, they will follow a detailed food list for 12 months with regular visits to the doctor. At each visit, the participating patients will be asked about their progress on weight loss and all measurements will be made. Simultaneously a control group of primary care physicians will also recruit patients that fulfill the inclusion criteria. These patients will also provide data that will serve as Control to the intervention group.
Read the detailed description
The number of patients with overweight is increasing and a daily issue in general practice. Many patients wish to discuss their weight problem with their family physician but many of these feel helpless to guide their patients in how to reduce weight. Providing useful and correct information should not be so difficult but many doctors choose to refer their patients to dietary courses or follow-up in specialist health care.In this study the investigators wish to implement a simple tool for treatment of overweight in primary care by providing the patients a detailed list for all meals that will ensure a weight loss. The patients will be given a close follow-up by their doctor, and the motivating conversation and list of meals will be the only treatment given.
The study is a cluster randomised controlled trial where all general practices in the area of Moss city in Norway will be asked to participate. Half of the physicians will constitute the intervention group while the other half will serve as control group. Each participating doctor in both groups will recruit patients according to the eligibility criteria. The doctors in the intervention group will be provided with a course to learn the intervention and have a manual to follow for each patient. All participating patients of both groups will be asked to meet regularly for data collection.
According to the power calculation, a number of 12 physicians in each group will be sufficient if they recruit 10 patients each.
The intervention will be conducted for 12 months and thereafter data will be continued to be collected at 6 and 12 months after.
- Being tested
- Intervention group
- Keywords
- overweight, general practice
- Medical subject headings
- Overweight, Obesity, Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Please see the preceding section
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 12 Family physicians in primary care will constitute the Intervention group. They will enroll 10 patients each from their ordinary practice. The physicians will be provided with a specific course on the treatment model of the study, including how to collect and register data. They will have a detailed manual indicating the content of each visit.
Following recruitment and consent, the patient will meet for the first visit in the study one week later. At this visit the patient will be provided with detailed information on the content and preparation for all meals. Data will be collected.
The manual describes a diet in accordance with official guidelines providing the patient 1600Kcal per day.
The following visits will take place after 4 weeks, 8 weeks, 4 months, 8 months and 12 months from the first visit. Data will be collected at all visits, and also at 6 and 12 months follow-up. Receives: Behavioral: Intervention group |
| Control group | No intervention | 12 Family physicians in primary care will constitute the Control group. They will enroll 10 patients each from their ordinary practice. The physicians will not be provided with any information of the treatment model of the study but they will have all information about how to collect and register data. The patients on this group will also sign consent to provide data and therefore they will know about the study but they do not get any specific information about weight loss other than the general information that their physician may tell them. The patients in the Control Group will be asked to give data on inclusion visit and again 12 months later, and also at 6 and 12 months thereafter (i.e. 0, 12, 18 and 24 months from inclusion). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction
10% weight reduction measured as kilo weight at inclusion
Measured: 12 months
Secondary outcomes (4)
Blood pressure
Blood pressure measured as mean of three measurements at rest
Measured: 12 months
HbA1c
Blood samples
Measured: 12 months
Waist measure
Any reduction in cm of waist measure
Measured: 12 months
Total Cholesterol
Blood samples
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2019
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik L Werner, University of Oslo
- Investigators
- Jørund Straand, Prof., Ph.D, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000062
- Sponsor's protocol ID
- MDN01
- Status last verified
- Jun 2021
- First submitted
- 13 Dec 2016
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Data on all outcomes will be available to researchers on request
Publications
Nilsen MD, Mdala I, Werner EL. Treatment of overweight and obesity in general practice: a cluster randomised trial. BMJ Nutr Prev Health. 2023 Nov 29;6(2):326-331. doi: 10.1136/bmjnph-2023-000721. eCollection 2023.
PubMed 38618545
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Overweight in General Practice
- ClinicalTrials.gov ID
- NCT03000062
- Acronym / sponsor ID
- MDN01
- Keywords
- overweight, general practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
In this study the investigators want to explore the feasibility and effect of a simple intervention provided by primary care physicians on treatment for overweight in general practice. Regular patients visiting their ordinary family physician will be asked for participation if they comply with the inclusion criteria. If so, they will follow a detailed food list for 12 months with regular visits to the doctor. At each visit, the participating patients will be asked about their progress on weight loss and all measurements will be made. Simultaneously a control group of primary care physicians will also recruit patients that fulfill the inclusion criteria. These patients will also provide data that will serve as Control to the intervention group.
Detailed description
The number of patients with overweight is increasing and a daily issue in general practice. Many patients wish to discuss their weight problem with their family physician but many of these feel helpless to guide their patients in how to reduce weight. Providing useful and correct information should not be so difficult but many doctors choose to refer their patients to dietary courses or follow-up in specialist health care.In this study the investigators wish to implement a simple tool for treatment of overweight in primary care by providing the patients a detailed list for all meals that will ensure a weight loss. The patients will be given a close follow-up by their doctor, and the motivating conversation and list of meals will be the only treatment given.
The study is a cluster randomised controlled trial where all general practices in the area of Moss city in Norway will be asked to participate. Half of the physicians will constitute the intervention group while the other half will serve as control group. Each participating doctor in both groups will recruit patients according to the eligibility criteria. The doctors in the intervention group will be provided with a course to learn the intervention and have a manual to follow for each patient. All participating patients of both groups will be asked to meet regularly for data collection.
According to the power calculation, a number of 12 physicians in each group will be sufficient if they recruit 10 patients each.
The intervention will be conducted for 12 months and thereafter data will be continued to be collected at 6 and 12 months after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention group12 Family physicians in primary care will constitute the Intervention group. They will enroll 10 patients each from their ordinary practice. The physicians will be provided with a specific course on the treatment model of the study, including how to collect and register data. They will have a detailed manual indicating the content of each visit. Following recruitment and consent, the patient will meet for the first visit in the study one week later. At this visit the patient will be provided with detailed information on the content and preparation for all meals. Data will be collected. The manual describes a diet in accordance with official guidelines providing the patient 1600Kcal per day. The following visits will take place after 4 weeks, 8 weeks, 4 months, 8 months and 12 months from the first visit. Data will be collected at all visits, and also at 6 and 12 months follow-up. |
| Control group | No intervention | –12 Family physicians in primary care will constitute the Control group. They will enroll 10 patients each from their ordinary practice. The physicians will not be provided with any information of the treatment model of the study but they will have all information about how to collect and register data. The patients on this group will also sign consent to provide data and therefore they will know about the study but they do not get any specific information about weight loss other than the general information that their physician may tell them. The patients in the Control Group will be asked to give data on inclusion visit and again 12 months later, and also at 6 and 12 months thereafter (i.e. 0, 12, 18 and 24 months from inclusion). |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI _> 30 OR _25 With at least one Medical condition related to overweight (hypertension, dyslipidemia, metabolic syndrome, diabetes mellitus II, hip- or knee pain)
- written consent
- sufficient knowledge in Norwegian Language to acquire the written and oral information
Key exclusion criteria (2 listed)
- any ongoing cancer condition
- any current medication impacting on weight
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 |
|---|---|---|
| Intervention groupPlease see the preceding section | Behavioural | Intervention group |
Primary outcome
Weight reduction
Time frame: 12 months
10% weight reduction measured as kilo weight at inclusion
4 secondary outcomes
Blood pressure
Time frame: 12 months
HbA1c
Time frame: 12 months
Waist measure
Time frame: 12 months
Total Cholesterol
Time frame: 12 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 22 Jun 2021.
- Derived from this study: PubMed 38618545Nilsen MD, Mdala I, Werner EL. Treatment of overweight and obesity in general practice: a cluster randomised trial. BMJ Nutr Prev Health. 2023 Nov 29;6(2):326-331. doi: 10.1136/bmjnph-2023-000721. eCollection 2023.
- Individual participant dataSharing planned: Undecided. Data on all outcomes will be available to researchers on 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.
Jørund Straand, Prof., Ph.D study director
University of Oslo
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Overweight and Obesity and Nutritional and Metabolic Diseases, run by University of Oslo.
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 3 inclusion and 2 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 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 reduction (time frame: 12 months). 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 NCT03000062, 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 22 Jun 2021.