Clinical trial NCT05149950: Internet Treatment for Patients With Obesity
Official title: Internet Treatment for Patients With Obesity - a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a strong link between obesity and reduced quality of life as well as serious sequelae of diseases. Step by step is a treatment model that has been developed at the Obesity Unit, Orebro County Region and includes six group meetings over 6-8 months. The aim is to increase patients' knowledge about the disease obesity, to provide support for lifestyle changes and weight control, and to reduce stigma-related psychosocial disorders. A 1-year pilot study aimed at evaluating the Internet-based Step by Step treatment has recently been completed. Results after 6 months of treatment show that the participants who completed the treatment were mainly satisfied with the program and the content. However, the dropouts from the treatment were more than expected.

Detailed description: Based on the experience from the pilot study, a new randomized study is planned with the aim of evaluating a revised treatment program. People 25-69 years with a BMI 30-44.9 kg / m2, or with a BMI 28-29.9 kg / m2 and co-occurrence of hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidemia, hepatic steatosis, sleep apnea or polycystic ovary syndrome can be included. The intervention group receives increased therapist support with physical or digital meetings before and during the treatment as well as individualized feedback from the therapist. Feedback takes place after 6, 12 and 18 weeks. The other group, the control group, implements the program without meetings with the therapist and receives general feedback during the treatment. The purpose is to evaluate whether increased therapist contact compared to less therapist contact leads to improved weight reduction, quality of life, eating habits and increases physical activity at follow-up after 12 months

Eligibility criteria: Inclusion Criteria:

* BMI 30-44.9 kg / m2
* BMI 28-29.9 kg / m2 and hypertension
* BMI 28-29.9 kg / m2 and prediabetes
* BMI 28-29.9 kg / m2 and type 2 diabetes
* BMI 28-29.9 kg / m2 and coronary heart disease
* BMI 28-29.9 kg / m2 and hyperlipidemia
* BMI 28-29.9 kg / m2 and hepatic steatosis
* BMI 28-29.9 kg / m2 and sleep apnea
* BMI 28-29.9 kg / m2 and polycystic ovary syndrome

Exclusion Criteria:

* Severe mental illness
* Ongoing or suspected eating disorder
* Pregnancy
* Breastfeeding
* Cancer in active treatment
* Use of drugs for weight loss
* Weight loss treatment during the past 6 months
* Active abuse of alcohol or drugs
* Not being able to express themselves in Swedish in speech and writing
* If the study supervisor deems that participation in the study is inappropriate for another reason.

Primary outcomes:
measure: Obesity-specific quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Weight reduction as a percentage of body weight before treatment
timeFrame: 6 and 12 months
measure: Proportion of participants with ≥ 5% weight reduction
timeFrame: 6 and 12 months
measure: General health-related quality of life
timeFrame: 6 and 12 months
measure: Obesity-specific quality of life: psychosocial distress
timeFrame: 6 and 12 months
measure: Dietary habits
timeFrame: 6 and 12 months
measure: Physical activity
timeFrame: 6 and 12 months
measure: Physical activity measured with an accelerometer
timeFrame: During 7 days before treatment and at 6 and 12 months
measure: Eating behavior
timeFrame: 6 and 12 months
measure: Sleep quality
timeFrame: 6 and 12 months
measure: Completion of the treatment program
timeFrame: 6 and 12 months
measure: The participants' experiences and experiences of the treatment
timeFrame: Every three weeks up to 24 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Stefan Jansson
Study officials:
affiliation: Region Orebro County
name: Mats G Karlsson, Prof
role: STUDY_CHAIR
References: