Internet Treatment for Patients With Obesity

NCT05149950 | Active Not Recruiting

• 1 other identifier: 276484
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Obesity-specific quality of life

  Avoidant social behavior due to obesity-related psychosocial disorders which is measured with the Obesity-related Problems scale "(OP)". The OP scale is validated to measure obesity-specific quality of life. OP measures the negative effects of obesity on psychosocial functioning and is useful for evaluating the effects of obesity interventions on quality of life. Scores range from 0 to 100, and higher scores indicate dysfunction.

  12 months

Secondary Outcomes (11)

• Weight reduction as a percentage of body weight before treatment

  6 and 12 months

• Proportion of participants with ≥ 5% weight reduction

  6 and 12 months

• General health-related quality of life

  6 and 12 months

• Obesity-specific quality of life: psychosocial distress

  6 and 12 months

• Dietary habits

  6 and 12 months

Study Arms (2)

Increased therapist contact.

EXPERIMENTAL

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.

Behavioral: Active internet treatment

Less therapist contact.

OTHER

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.

Behavioral: Active internet treatment

Interventions

Active internet treatment BEHAVIORAL

The patient gets access to the internet treatment via a secure login to 1177 The care guide e-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.

Increased therapist contact.; Less therapist contact.

Eligibility Criteria

• Age: 25 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Stefan Jansson

Örebro, 70116, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mats G Karlsson, Prof

  Region Orebro County

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 8, 2021
• Study Start: January 3, 2022
• Primary Completion: January 15, 2025
• Study Completion: November 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)