Internet Treatment for Persons With Overweight or Obesity

April 28, 2022 updated by: Region Örebro County

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 703 62
        • Obesity Unit, Örebro University Hospital, Region Örebro County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet treatment for overweight and obese patients
The 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.
Behavioral: Internet treatment for overweight and obese patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: Change from baseline to follow-up at 6 months and 12 months
Weight reduction in kg
Change from baseline to follow-up at 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary habits
Time Frame: Change from baseline to follow-up at 6 months and 12 months
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.
Change from baseline to follow-up at 6 months and 12 months
Physical activity
Time Frame: Change from baseline to follow-up at 6 months and 12 months
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.
Change from baseline to follow-up at 6 months and 12 months
Psychosocial functioning
Time Frame: Change from baseline to follow-up at 6 months and 12 months
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).
Change from baseline to follow-up at 6 months and 12 months
Experiences of the treatment program
Time Frame: From treatment start to follow-up after treatment ends at 6 months
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 .
From treatment start to follow-up after treatment ends at 6 months
Experiences of the treatment effects
Time Frame: From baseline to follow-up at 6 months and 12 months
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.
From baseline to follow-up at 6 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Causes of drop-out from treatment
Time Frame: Within two weeks of the end of treatment
Interviews with participants who finish the treatment prematurely
Within two weeks of the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Investigators

  • Principal Investigator: Stefan Jansson, MD, PhD, Region Örebro County

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 272763

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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