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A Group-based Treatment of Overweight and Obesity in Primary Care

Primary Purpose

Overweight and Obesity

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
A group-based treatment of overweight and obesity
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring overweight, obesity, group treatment, primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years and older
  • BMI 30 or over
  • BMI over 28 and under 30 with one or more of following: hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidaemia, liver steatosis, sleep apnoea or polycystic ovary syndrome.

Exclusion Criteria:

  • Severe mental illness
  • Previous or present eating disorder
  • Pregnancy
  • Breast feeding
  • Serious cancer under treatment
  • Use of weight-loss drugs
  • Misuse of alcohol or drugs
  • Type 1 diabetes
  • Not being able to speak/read/write Swedish.

Sites / Locations

  • Region Orebro lan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group treatment in primary care

Arm Description

The intervention is a group treatment of overweight and obesity in primary care inspired by cognitive behavioural therapy. The main goal of the group treatment is for the participants to obtain and maintain healthy lifestyle habits, with emphasis on diet and physical activity. Every group has 8-12 participants and is led by two persons; the main group leader is either a primary care nurse or a physiotherapist with special training. The groups meet six times (2 hours every time) once a month over a 6-8 month period. Every group session has a set agenda with different topics, for example a healthy diet, recommended physical activity or how to deal with setbacks. Between group sessions there are home assignments. The home assignments are followed-up at the next session and participants are encouraged to share experiences with each other in order to inspire, challenge and help fellow group participants. Data is collected prior to the start of group treatment, after 6-8 and 12 months.

Outcomes

Primary Outcome Measures

Weight reduction in kg and % from baseline to 6-8 months and 12 months.
Measured in kilograms

Secondary Outcome Measures

Change in Dietary habits
Measured by a questionnaire from The National Board of Health and Welfare with 4 questions regarding how often the person eats vegetables, fruit, fish and sweets.
Change in Physical activity
Measured by accelerometer.
Change in general Health-related Quality of Life
Measured by Rand 36-item Health survey. Comprises 36 items that assess 8 health concepts: physical functioning, role limitations, social functioning, emotional wellbeing, energy/fatigue, pain and general health perceptions. Subscale scores range from 0 to 100, where higher scores represent better health status.
Change in Obesity-specific Health-related Quality of Life
Measured by the Obesity-Related Problems scale (OP V1.2). Comprises 8 items with a response choice from 1-4: 1 = Definitely bothered, 2 = Mostly bothered, 3 = Not so bothered and 4 = Definitely not bothered. The scores are transformed to a raw scale score that is then transformed to a 0-100 scale. A higher score indicates more psychosocial problems.
Change in Eating patterns
Measured by the Three-Factor Eating Questionnaire (TFEQ-R18v2). Comprises 18 items that measure 3 domains of eating behaviour: cognitive restraint, uncontrolled eating and emotional eating. The items are answered on a 4-point Likert scale. The raw scale scores are transformed to a 0 to 100 scale where higher scores indicate more uncontrolled, restraint and emotional eating.
Change in Systolic and Diastolic Blood pressure
Measured by measuring the blood pressure.
Change in blood glucose
Measured by blood test: glucose
Change in blood cholesterol
Measured by blood test:cholesterol
Change in blood triglycerides
Measured by blood test: triglycerides

Full Information

First Posted
April 10, 2019
Last Updated
May 4, 2022
Sponsor
Region Örebro County
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1. Study Identification

Unique Protocol Identification Number
NCT03914066
Brief Title
A Group-based Treatment of Overweight and Obesity in Primary Care
Official Title
A Group-based Treatment of Overweight and Obesity in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
We could not continue the study and include participants because of the corona pandemic.
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
February 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Overweight and obesity is a growing problem in the world. Today more than 50 % of all people over 18 years in Sweden are overweight or obese. Main reasons for this are changes in lifestyle habits regarding diet and physical exercise. Overweight and obesity increases risk of different diseases such as type 2 diabetes, arthrosis and cancer; it also affects quality of life. Losing 5-10 % of your body weight improves metabolic health and quality of life. Lifestyle changes are very important in order to lose weight but it can be challenging to carry through with these changes on your own without support. In the primary care in Region Orebro län a group treatment, "Step by step", has been in use since 2010. It comprises of six group sessions over 6-8 months with different themes such as diet, physical exercise and stress. Between the group sessions there are home assignments, such as writing a diet or exercise diary. This observational study will evaluate "Step by step" and the effect the group treatment has on the participants' weight, dietary habits, physical activity, quality of life, eating habits and metabolic health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
overweight, obesity, group treatment, primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group treatment in primary care
Arm Type
Experimental
Arm Description
The intervention is a group treatment of overweight and obesity in primary care inspired by cognitive behavioural therapy. The main goal of the group treatment is for the participants to obtain and maintain healthy lifestyle habits, with emphasis on diet and physical activity. Every group has 8-12 participants and is led by two persons; the main group leader is either a primary care nurse or a physiotherapist with special training. The groups meet six times (2 hours every time) once a month over a 6-8 month period. Every group session has a set agenda with different topics, for example a healthy diet, recommended physical activity or how to deal with setbacks. Between group sessions there are home assignments. The home assignments are followed-up at the next session and participants are encouraged to share experiences with each other in order to inspire, challenge and help fellow group participants. Data is collected prior to the start of group treatment, after 6-8 and 12 months.
Intervention Type
Behavioral
Intervention Name(s)
A group-based treatment of overweight and obesity
Intervention Description
The intervention is a group treatment of overweight and obesity in primary care inspired by cognitive behavioural therapy. The main goal of the group treatment is for the participants to obtain and maintain healthy lifestyle habits, with emphasis on diet and physical activity. Every group has 8-12 participants and is led by two persons; the main group leader is either a primary care nurse or a physiotherapist with special training. The groups meet six times (2 hours every time) once a month over a 6-8 month period. Every group session has a set agenda with different topics, for example a healthy diet, recommended physical activity or how to deal with setbacks. Between group sessions there are home assignments. The home assignments are followed-up at the next session and participants are encouraged to share experiences with each other in order to inspire, challenge and help fellow group participants. Data is collected prior to the start of group treatment, after 6-8 and 12 months.
Primary Outcome Measure Information:
Title
Weight reduction in kg and % from baseline to 6-8 months and 12 months.
Description
Measured in kilograms
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Secondary Outcome Measure Information:
Title
Change in Dietary habits
Description
Measured by a questionnaire from The National Board of Health and Welfare with 4 questions regarding how often the person eats vegetables, fruit, fish and sweets.
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Title
Change in Physical activity
Description
Measured by accelerometer.
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Title
Change in general Health-related Quality of Life
Description
Measured by Rand 36-item Health survey. Comprises 36 items that assess 8 health concepts: physical functioning, role limitations, social functioning, emotional wellbeing, energy/fatigue, pain and general health perceptions. Subscale scores range from 0 to 100, where higher scores represent better health status.
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Title
Change in Obesity-specific Health-related Quality of Life
Description
Measured by the Obesity-Related Problems scale (OP V1.2). Comprises 8 items with a response choice from 1-4: 1 = Definitely bothered, 2 = Mostly bothered, 3 = Not so bothered and 4 = Definitely not bothered. The scores are transformed to a raw scale score that is then transformed to a 0-100 scale. A higher score indicates more psychosocial problems.
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Title
Change in Eating patterns
Description
Measured by the Three-Factor Eating Questionnaire (TFEQ-R18v2). Comprises 18 items that measure 3 domains of eating behaviour: cognitive restraint, uncontrolled eating and emotional eating. The items are answered on a 4-point Likert scale. The raw scale scores are transformed to a 0 to 100 scale where higher scores indicate more uncontrolled, restraint and emotional eating.
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Title
Change in Systolic and Diastolic Blood pressure
Description
Measured by measuring the blood pressure.
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Title
Change in blood glucose
Description
Measured by blood test: glucose
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Title
Change in blood cholesterol
Description
Measured by blood test:cholesterol
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.
Title
Change in blood triglycerides
Description
Measured by blood test: triglycerides
Time Frame
Change from baseline to follow-up at 6-8 months and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and older BMI 30 or over BMI over 28 and under 30 with one or more of following: hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidaemia, liver steatosis, sleep apnoea or polycystic ovary syndrome. Exclusion Criteria: Severe mental illness Previous or present eating disorder Pregnancy Breast feeding Serious cancer under treatment Use of weight-loss drugs Misuse of alcohol or drugs Type 1 diabetes Not being able to speak/read/write Swedish.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agneta Anderzén Carlsson, RN, Assoc. P
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Orebro lan
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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A Group-based Treatment of Overweight and Obesity in Primary Care

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