Overweight and ObesityNCT03914066
A Group-based Treatment of Overweight and Obesity in Primary Care
A study testing A group-based treatment of overweight and obesity in people with Overweight and Obesity, run by Region Örebro County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- A group-based treatment of overweight and obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSweden
- Study dates
- 3 Sep 2019to 22 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe mental illness
- Previous or present eating disorder
- Pregnancy
- Breast feeding
- Serious cancer under treatment
- Use of weight-loss drugs
Show all 9Show fewer
- Misuse of alcohol or drugs
- Type 1 diabetes
- Not being able to speak/read/write Swedish.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Overweight and Obesity
- Being tested
- A group-based treatment of overweight and obesity
- Keywords
- overweight, obesity, group treatment, primary care
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A group-based treatment of overweight and obesityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group treatment in primary care | Experimental | 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. Receives: Behavioral: A group-based treatment of overweight and obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction in kg and % from baseline to 6-8 months and 12 months.
Measured in kilograms
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
Secondary outcomes (9)
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.
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
Change in Physical activity
Measured by accelerometer.
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
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.
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
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.
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
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.
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
Change in Systolic and Diastolic Blood pressure
Measured by measuring the blood pressure.
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
Change in blood glucose
Measured by blood test: glucose
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
Change in blood cholesterol
Measured by blood test:cholesterol
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
Change in blood triglycerides
Measured by blood test: triglycerides
Measured: Change from baseline to follow-up at 6-8 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start3 Sep 2019
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Why it stopped: We could not continue the study and include participants because of the corona pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agneta Anderzén Carlsson, RN, Assoc. P, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914066
- Sponsor's protocol ID
- 267621
- Status last verified
- May 2021
- First submitted
- 10 Apr 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group-based Treatment of Overweight and Obesity in Primary Care
- ClinicalTrials.gov ID
- NCT03914066
- Acronym / sponsor ID
- 267621
- Conditions
- Overweight and Obesity
- Keywords
- overweight, obesity, group treatment, primary care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We could not continue the study and include participants because of the corona pandemic.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group treatment in primary care | Experimental | Behavioral: A group-based treatment of overweight and obesityThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Severe mental illness
- Previous or present eating disorder
- Pregnancy
- Breast feeding
- Serious cancer under treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A group-based treatment of overweight and obesityThe 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. | Behavioural | Group treatment in primary care |
Primary outcome
Weight reduction in kg and % from baseline to 6-8 months and 12 months.
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Measured in kilograms
9 secondary outcomes
Change in Dietary habits
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Change in Physical activity
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Change in general Health-related Quality of Life
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Change in Obesity-specific Health-related Quality of Life
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Change in Eating patterns
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Change in Systolic and Diastolic Blood pressure
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Change in blood glucose
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Change in blood cholesterol
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Change in blood triglycerides
Time frame: Change from baseline to follow-up at 6-8 months and 12 months.
Results and safety
The study was stopped early (reason given: We could not continue the study and include participants because of the corona pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agneta Anderzén Carlsson, RN, Assoc. P principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A group-based treatment of overweight and obesity in people with Overweight and Obesity, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We could not continue the study and include participants because of the corona pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight reduction in kg and % from baseline to 6-8 months and 12 months. (time frame: Change from baseline to follow-up at 6-8 months and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.