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Treatment of Overweight in General Practice

Primary Purpose

Overweight and Obesity, Nutritional and Metabolic Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention group
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring overweight, general practice

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    Weight reduction
    10% weight reduction measured as kilo weight at inclusion

    Secondary Outcome Measures

    Blood pressure
    Blood pressure measured as mean of three measurements at rest
    HbA1c
    Blood samples
    Waist measure
    Any reduction in cm of waist measure
    Total Cholesterol
    Blood samples

    Full Information

    First Posted
    December 13, 2016
    Last Updated
    June 21, 2021
    Sponsor
    University of Oslo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03000062
    Brief Title
    Treatment of Overweight in General Practice
    Official Title
    Treatment of Overweight in General Practice
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    December 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Oslo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity, Nutritional and Metabolic Diseases
    Keywords
    overweight, general practice

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cluster randomized controlled trial
    Masking
    Participant
    Masking Description
    ID of participating patients are only available through the participating Family phyisican
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intervention group
    Intervention Description
    Please see the preceding section
    Primary Outcome Measure Information:
    Title
    Weight reduction
    Description
    10% weight reduction measured as kilo weight at inclusion
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Blood pressure
    Description
    Blood pressure measured as mean of three measurements at rest
    Time Frame
    12 months
    Title
    HbA1c
    Description
    Blood samples
    Time Frame
    12 months
    Title
    Waist measure
    Description
    Any reduction in cm of waist measure
    Time Frame
    12 months
    Title
    Total Cholesterol
    Description
    Blood samples
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    Qualitative study
    Description
    Participating physicians and patients will be interviewed about their experiences With the intervention
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jørund Straand, Prof., Ph.D
    Organizational Affiliation
    University of Oslo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Data on all outcomes will be available to researchers on request

    Learn more about this trial

    Treatment of Overweight in General Practice

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