Treatment of Overweight in General Practice

NCT03000062 | Completed DMC

• 1 other identifier: MDN01
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity; Nutritional and Metabolic Diseases

Keywords

overweight, general practice

Outcome Measures

Primary Outcomes (1)

• Weight reduction

  10% weight reduction measured as kilo weight at inclusion

  12 months

Secondary Outcomes (4)

• Blood pressure

  12 months

• HbA1c

  12 months

• Waist measure

  12 months

• Total Cholesterol

  12 months

Other Outcomes (1)

• Qualitative study

  24 months

Study Arms (2)

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.

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).

Interventions

Intervention group BEHAVIORAL

Please see the preceding section

Intervention group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oslo: lead

Related Publications (1)

• 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.

  PMID: 38618545 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Nutritional and Metabolic Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jørund Straand, Prof., Ph.D

  University of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: ID of participating patients are only available through the participating Family phyisican
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 21, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: June 22, 2021

Record last verified: 2021-06