ObesityROLobesNCT05149950
Internet Treatment for Patients With Obesity
A study testing Active internet treatment in people with Obesity, run by Region Örebro County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 69 years
- Conditions the study is for
- Obesity
- What is being tested?
- Active internet treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 3 Jan 2022to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Severe mental illness
- Ongoing or suspected eating disorder
- Pregnancy
- Breastfeeding
- Cancer in active treatment
- Use of drugs for weight loss
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity
- Being tested
- Active internet treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active internet treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active internet treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (11)
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
Measured: 6 and 12 months
Proportion of participants with ≥ 5% weight reduction
Proportion of participants with ≥ 5% weight reduction in kilograms
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 and 12 months
Completion of the treatment program
Percentage who complete the treatment program
Measured: 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 program
- to understand the language
- to absorb the content
- to access and use the program
- to understand the homework and whether these were relevant / helpful
- how helpful the feedback from the therapist is
- what can be improved
Measured: Every three weeks up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start3 Jan 2022
- Primary completion15 Jan 2025
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mats G Karlsson, Prof, Study chair, Region Orebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149950
- Sponsor's protocol ID
- 276484
- Acronym
- ROLobes
- Status last verified
- Apr 2025
- First submitted
- 3 Nov 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Treatment for Patients With Obesity - a Randomized Study
- ClinicalTrials.gov ID
- NCT05149950
- Acronym / sponsor ID
- ROLobes / 276484
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased therapist contact. | Experimental | Behavioral: Active internet treatmentThe 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. |
| Less therapist contact. | Other | Behavioral: Active internet treatmentThe 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. |
Who may qualify
- Ages
- 25 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- Severe mental illness
- Ongoing or suspected eating disorder
- Pregnancy
- Breastfeeding
- Cancer in active treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active internet treatmentThe 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. | Behavioural | Increased therapist contact., Less therapist contact. |
Primary outcome
Obesity-specific quality of life
Time frame: 12 months
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.
11 secondary outcomes
Weight reduction as a percentage of body weight before treatment
Time frame: 6 and 12 months
Proportion of participants with ≥ 5% weight reduction
Time frame: 6 and 12 months
General health-related quality of life
Time frame: 6 and 12 months
Obesity-specific quality of life: psychosocial distress
Time frame: 6 and 12 months
Dietary habits
Time frame: 6 and 12 months
Physical activity
Time frame: 6 and 12 months
Physical activity measured with an accelerometer
Time frame: During 7 days before treatment and at 6 and 12 months
Eating behavior
Time frame: 6 and 12 months
Sleep quality
Time frame: 6 and 12 months
Completion of the treatment program
Time frame: 6 and 12 months
The participants' experiences and experiences of the treatment
Time frame: Every three weeks up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mats G Karlsson, Prof study chair
Region Orebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active internet treatment in people with Obesity, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity-specific quality of life (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.