Clinical trial NCT03000062: Treatment of Overweight in General Practice
Official title: Treatment of Overweight in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Nutritional and Metabolic Diseases
Keywords: overweight, general practice
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* any ongoing cancer condition
* any current medication impacting on weight

Primary outcomes:
measure: Weight reduction
timeFrame: 12 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 months
measure: Waist measure
timeFrame: 12 months
measure: Total Cholesterol
timeFrame: 12 months
Other outcomes:
measure: Qualitative study
timeFrame: 24 months
Locations:
Study officials:
affiliation: University of Oslo
name: Jørund Straand, Prof., Ph.D
role: STUDY_DIRECTOR
References: