Treatment of Overweight in General Practice

Overweight and Obesity Clinical Trial

Official title:

Treatment of Overweight in General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000062
• Other study ID #: MDN01
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: June 2021
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Intervention group
Please see the preceding section

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative study	Participating physicians and patients will be interviewed about their experiences With the intervention	24 months
Primary	Weight reduction	10% weight reduction measured as kilo weight at inclusion	12 months
Secondary	Blood pressure	Blood pressure measured as mean of three measurements at rest	12 months
Secondary	HbA1c	Blood samples	12 months
Secondary	Waist measure	Any reduction in cm of waist measure	12 months
Secondary	Total Cholesterol	Blood samples	12 months