Clinical trial NCT04150445: Internet Treatment for Persons With Overweight or Obesity
Official title: Internet Treatment for Overweight and Obese Patients - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Body Weight
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 22
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 are increasing and more than 50% of all people over 18 years in Sweden are overweight or obese. Main causes are changes in lifestyle habits regarding diet and physical activity. Obesity increases the risk of various diseases such as type 2 diabetes, cardiovascular disease, arthrosis and cancer; it also affects the quality of life. Losing 5-10% of body weight can improve metabolic health and quality of life. However, weight loss is difficult to achieve and especially to maintain over a longer period of time. Treatment based on cognitive behavioral therapy improves long-term outcomes. A behavioral treatment program via the Internet has been developed that contains 12 treatment modules that the patient follows for 6 months. The patient has regular contact with a therapist who follows the patient's treatment process and provides support. The purpose of this pilot study is to evaluate the Internet-based treatment regarding weight reduction, change in eating habits, physical activity and quality of life. We also intend to investigate how feasible and user-friendly the treatment program is and the patients' experiences of the treatment effects.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* BMI 30 or over
* BMI over 28 and under 30 with one or more of the following: hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidaemia, liver steatosis, sleep apnea 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
* Weight loss treatment in the last 6 months
* Misuse of alcohol or drugs
* Type 1 diabetes
* Not being able to speak/read/write Swedish

Primary outcomes:
measure: Body weight
timeFrame: Change from baseline to follow-up at 6 months and 12 months
Secondary outcomes:
measure: Dietary habits
timeFrame: Change from baseline to follow-up at 6 months and 12 months
measure: Physical activity
timeFrame: Change from baseline to follow-up at 6 months and 12 months
measure: Psychosocial functioning
timeFrame: Change from baseline to follow-up at 6 months and 12 months
measure: Experiences of the treatment program
timeFrame: From treatment start to follow-up after treatment ends at 6 months
measure: Experiences of the treatment effects
timeFrame: From baseline to follow-up at 6 months and 12 months
Other outcomes:
measure: Causes of drop-out from treatment
timeFrame: Within two weeks of the end of treatment
Locations:
city: Örebro
country: Sweden
facility: Obesity Unit, Örebro University Hospital, Region Örebro County
Study officials:
affiliation: Region Örebro County
name: Stefan Jansson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: