Clinical trial NCT03914066: 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
Overall status: TERMINATED
Phase: NA
Conditions: Overweight and Obesity
Keywords: overweight
obesity
group treatment
primary care
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Weight reduction in kg and % from baseline to 6-8 months and 12 months.
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
Secondary outcomes:
measure: Change in Dietary habits
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
measure: Change in Physical activity
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
measure: Change in general Health-related Quality of Life
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
measure: Change in Obesity-specific Health-related Quality of Life
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
measure: Change in Eating patterns
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
measure: Change in Systolic and Diastolic Blood pressure
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
measure: Change in blood glucose
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
measure: Change in blood cholesterol
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
measure: Change in blood triglycerides
timeFrame: Change from baseline to follow-up at 6-8 months and 12 months.
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Region Orebro lan
Study officials:
affiliation: Örebro University, Sweden
name: Agneta Anderzén Carlsson, RN, Assoc. P
role: PRINCIPAL_INVESTIGATOR
References: