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OpenTrials
Completed

NCT Number: NCT03000062

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

Please see the preceding section

Primary outcomes

  1. Weight reduction

    Time frame: 12 months

    10% weight reduction measured as kilo weight at inclusion

Secondary outcomes

  1. Blood pressure

    Time frame: 12 months

    Blood pressure measured as mean of three measurements at rest

  2. HbA1c

    Time frame: 12 months

    Blood samples

  3. Waist measure

    Time frame: 12 months

    Any reduction in cm of waist measure

  4. Total Cholesterol

    Time frame: 12 months

    Blood samples

Other outcomes

  1. Qualitative study

    Time frame: 24 months

    Participating physicians and patients will be interviewed about their experiences With the intervention

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 21, 2016
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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