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Overweight and ObesityNCT04150445

Internet Treatment for Persons With Overweight or Obesity

A study testing Internet treatment for overweight and obese patients in people with Overweight and Obesity, run by Region Örebro County at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Overweight and obesity are increasing and more than 50% of all people over 18 years in Sweden are overweight or obese. Main causes are changes in lifestyle habits regarding diet and physical activity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight and Obesity
What is being tested?
Internet treatment for overweight and obese patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSweden
Study dates
10 Dec 2019to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years and older
  • BMI 30 or over
  • BMI over 28 and under 30 with one or more of the following: hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidaemia, liver steatosis, sleep apnea or polycystic ovary syndrome

Who cannot join

  • Severe mental illness
  • Previous or present eating disorder
  • Pregnancy
  • Breast feeding
  • Serious cancer under treatment
  • Use of weight-loss drugs
Show all 10Show fewer
  • Weight loss treatment in the last 6 months
  • Misuse of alcohol or drugs
  • Type 1 diabetes
  • Not being able to speak/read/write Swedish

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Obesity Unit, Örebro University Hospital, Region Örebro County

    Örebro, 703 62

Other trials in Sweden

About this study

Official title: Internet Treatment for Overweight and Obese Patients - a Pilot Study

Overweight and obesity are increasing and more than 50% of all people over 18 years in Sweden are overweight or obese. Main causes are changes in lifestyle habits regarding diet and physical activity. Obesity increases the risk of various diseases such as type 2 diabetes, cardiovascular disease, arthrosis and cancer; it also affects the quality of life. Losing 5-10% of body weight can improve metabolic health and quality of life. However, weight loss is difficult to achieve and especially to maintain over a longer period of time. Treatment based on cognitive behavioral therapy improves long-term outcomes. A behavioral treatment program via the Internet has been developed that contains 12 treatment modules that the patient follows for 6 months. The patient has regular contact with a therapist who follows the patient's treatment process and provides support. The purpose of this pilot study is to evaluate the Internet-based treatment regarding weight reduction, change in eating habits, physical activity and quality of life. We also intend to investigate how feasible and user-friendly the treatment program is and the patients' experiences of the treatment effects.

Being tested
Internet treatment for overweight and obese patients
Keywords
Overweight, Obesity, Body Weight
Medical subject headings
Overweight, Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet treatment for overweight and obese patientsBehavioural

    The behavioral treatment is provided via the Internet and comprises 12 modules that the patient follows for 6 months. The treatment modules include self-monitoring, goal setting, relapse prevention, psycho-education about nutrition, eating behavior, physical activity, sleep and stress management. Each module ends with one or more exercises to be completed before the next module is activated.

Study groups in NCT04150445
Study groupRoleWhat they receive
Internet treatment for overweight and obese patientsExperimentalThe intervention is a treatment of overweight and obesity based on cognitive behavioural therapy provided via the Internet. The treatment lasts for six months and comprises 12 treatment modules. The patient works with each module for two weeks. The modules conclude with one or more exercise tasks to be performed before the next module is activated. The patient has written contact with the therapist via the Internet platform.
Receives: Behavioral: Internet treatment for overweight and obese patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    Weight reduction in kg

    Measured: Change from baseline to follow-up at 6 months and 12 months

Secondary outcomes (5)

  1. Dietary habits

    Change in dietary habits measured by a questionnaire from the National Board of Health and Welfare, Sweden. The questionnaire includes five questions about how often the person eats vegetables, fruits, fish, sweets and breakfast.

    Measured: Change from baseline to follow-up at 6 months and 12 months

  2. Physical activity

    Change in physical activity measured with a questionnaire from The National Board of Health and Welfare, Sweden. The questionnaire contains two questions about exercise and everyday activities that 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.

    Measured: Change from baseline to follow-up at 6 months and 12 months

  3. Psychosocial functioning

    Change in weight-related psychosocial functioning measured by the Obesity-related Problems scale, version 3 (OPv3). OPv3 comprises 26 items on a four-point response scale. The participants indicate how bothered they are by their obesity in a broad range of social activities and to what extent they avoid social activities because of their obesity. The responses are aggregated into two domains: Distress (13 items) and Avoidance (13 items). Scale scores range from 0 (no distress/avoidance) to 100 (maximum distress/avoidance).

    Measured: Change from baseline to follow-up at 6 months and 12 months

  4. Experiences of the treatment program

    The patient's experiences of the treatment program are measured with five study-specific questions about how easy or difficult it was 1) to follow the treatment program, 2) to understand the language and content, 3) to use the program 4) to understand the home tasks and if they were relevant, and 5) how useful feedback from the therapist was .

    Measured: From treatment start to follow-up after treatment ends at 6 months

  5. Experiences of the treatment effects

    The patient's experiences of the treatment effects are measured with study-specific questions (18 and 15 questions at 6 and 12 months follow-up respectively). The questions concern the following aspects: 1) if the treatment has been helpful in making lifestyle changes, 2) if the participant is satisfied or dissatisfied with the weight change, 3) if the participant considers that the treatment has had an effect on health and well-being.

    Measured: From baseline to follow-up at 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start10 Dec 2019
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04150445
Sponsor's protocol ID
272763
Status last verified
Apr 2022
First submitted
23 Oct 2019
Last updated
2 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anderzen-Carlsson A, Imhagen A, Jansson S, Galavazi M, Karlsson J. Experiences From an Internet-Delivered Treatment Program for Individuals With Obesity: Pilot Study. JMIR Form Res. 2026 Apr 17;10:e79853. doi: 10.2196/79853.

    PubMed 41996366

Questions about this trial

What is this clinical trial studying?

A study testing Internet treatment for overweight and obese patients in people with Overweight and 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 3 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: finished, as of the sponsor's last update on 2 May 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Body weight (time frame: Change from baseline to follow-up at 6 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04150445, which also lists 1 linked publication.

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 2 May 2022.

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