Internet Treatment for Patients With Obesity (ROLobes)

Internet Treatment for Patients With Obesity - a Randomized Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Active internet treatment

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70116
    • Stefan Jansson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Increased therapist contact.; 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; 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.
Other: Less therapist contact.; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight reduction as a percentage of body weight before treatment	Each participant's weight reduction in kilograms reported as a percentage of body weight before starting treatment	6 and 12 months
Proportion of participants with ≥ 5% weight reduction	Proportion of participants with ≥ 5% weight reduction in kilograms	6 and 12 months
General health-related quality of life	General quality of life is measured with RAND-36 which consists of 36 questions and measures 8 health domains: physical function, role function-physical, pain, general health, energy / fatigue, social function, role function-emotional and emotional well-being. Using the standard scoring algorithm from RAND Corporation, eight conceptual attributes (subscales) are calculated by averaging values of 35 of the 36 ordinal scale items. The remaining item (general health change), assesses change in perceived health during the last year. Subscale scores range from 0 to 100, where higher scores represent better health status.The Swedish version is validated	6 and 12 months
Obesity-specific quality of life: psychosocial distress	Psychosocial distress due to obesity-related problems 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.	6 and 12 months
Dietary habits	Dietary habits are measured by the National Board of Health and Welfare's five dietary index questions. The questions measure how often the person eats 1) vegetables, 2) fruit, 3) fish, 4) coffee bread / chocolate / sweets / soft drinks, and 5) how often the person eats breakfast.	6 and 12 months
Physical activity	Measured with the National Board of Health and Welfare three indicator questions about exercise, exercise and sitting still. The questions measure how much time per week the person performs 1) strenuous activities, e.g. running, playing ball, and 2) moderately strenuous activities, e.g. walking, cycling and 3) how many hours during the day the person is sedentary.	6 and 12 months
Physical activity measured with an accelerometer	Measured with an accelerometer for 7 days before treatment and at follow-up at 6 and 12 months after the start of treatment. The measurement is made with the Actigraph GTX3 + monitor which is distributed or sent home to participants at the above times. Data on physical activity are combined with body weight to calculate energy consumption. During the 7 days that the survey takes place, the participants document various activities in a diary.	During 7 days before treatment and at 6 and 12 months
Eating behavior	Eating behavior is measured with the Three-Factor Eating Questionnaire-Revised 18 items (TFEQ-R18v2) which is a validated questionnaire consisting of 18 questions that measure three aspects of eating behavior: uncontrolled eating (tendency to lose control over intake when you feel hungry or when you exposed to external stimuli), cognitive restraint (conscious restriction of food intake to control body weight or body shape) and emotional eating (overeating in connection with negative emotional states).Responses are scored on a 4-point scale, and anchors can vary across items (e.g., definitely true to definitely false, or never to at least once a week). Means are computed for each subscale (as long as at least half of the items have been answered) and are transformed to correspond to a 0-100 scale score. A higher score indicates more restraint, uncontrolled, and emotional eating.	6 and 12 months
Sleep quality	Measured with the Insomnia Severity Index (ISI) which consists of 7 questions that evaluate sleep, sleep during the night, waking up early, the feeling of being rested, how the sleep problems affect daily life, and whether the sleep pattern worries the individual. The scale score ranges between 0-28 and a higher score indicates more sleep problems.	6 and 12 months
Completion of the treatment program	Percentage who complete the treatment program	6 and 12 months
The participants' experiences and experiences of the treatment	The patient's experience of the treatment program is measured with questions after each treatment module and at the end of treatment after 6 months. The questionnaire questions are answered in the treatment platform and contain questions about: how easy or difficult it is to follow the treatment programto understand the languageto absorb the contentto access and use the programto understand the homework and whether these were relevant / helpfulhow helpful the feedback from the therapist iswhat can be improved	Every three weeks up to 24 weeks

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Study Chair: Mats G Karlsson, Prof, Region Örebro county

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): January 15, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: 276484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No