Treatment of Overweight in General Practice

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Nutritional and Metabolic Diseases
• Intervention / Treatment: Behavioral: 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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Intervention group; Please see the preceding section
NO_INTERVENTION: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight reduction	10% weight reduction measured as kilo weight at inclusion	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure measured as mean of three measurements at rest	12 months
HbA1c	Blood samples	12 months
Waist measure	Any reduction in cm of waist measure	12 months
Total Cholesterol	Blood samples	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative study	Participating physicians and patients will be interviewed about their experiences With the intervention	24 months

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Study Director: Jørund Straand, Prof., Ph.D, University of Oslo

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 18, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: overweight, general practice
• Additional Relevant MeSH Terms: Body Weight; Overweight; Metabolic Diseases
• Other Study ID Numbers: MDN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data on all outcomes will be available to researchers on request