Internet Treatment for Patients With Obesity (ROLobes)

Region Örebro County

Status: Active, not recruiting

Conditions: Obesity

Treatments: Behavioral: Active internet treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05149950

276484

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 25 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Increased therapist contact.

Experimental group

Description:

The patient gets access to the internet treatment via a secure login to 1177 The care guide-services on 1177.se. The treatment lasts for six months and includes 12 treatment modules. The patient works with each module for two weeks. The modules have different numbers of sections, but most have 4-5 sections. The modules consist mainly of text but also films and pictures are included. It is also possible to listen to the text. The modules end with one or more exercises to be performed before the next module is activated for the patient. Participants receive feedback on the information from therapists via the email function in the treatment program. The therapist provides individual feedback on completed exercises and answers questions that the patient has.

Treatment:

Behavioral: Active internet treatment

Less therapist contact.

Other group

Description:

The feedback from the therapist will largely be general and not individually tailored. The general feedback is based on responses to the participants in the previous pilot study. No physical or digital meetings between patient and therapist take place during treatment.

Treatment:

Behavioral: Active internet treatment