Treatment of Overweight in General Practice

NCT ID: NCT03000062

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Overweight and Obesity; Nutritional and Metabolic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: BEHAVIORAL

Please see the preceding section

Control group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention group

Please see the preceding section

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Erik L Werner

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jørund Straand, Prof., Ph.D

Role: STUDY_DIRECTOR

University of Oslo

References

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.

Reference Type: DERIVED

PMID: 38618545 (View on PubMed)

Other Identifiers

MDN01

Identifier Type: -

Identifier Source: org_study_id