Internet Treatment for Persons With Overweight or Obesity
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet treatment for overweight and obese patients
Sponsored by

About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Overweight, Obesity, Body Weight
Eligibility Criteria
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
Sites / Locations
- Obesity Unit, Örebro University Hospital, Region Örebro County
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Internet treatment for overweight and obese patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Body weight
Weight reduction in kg
Secondary Outcome Measures
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.
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.
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).
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 .
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04150445
Brief Title
Internet Treatment for Persons With Overweight or Obesity
Official Title
Internet Treatment for Overweight and Obese Patients - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight, Obesity, Body Weight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet treatment for overweight and obese patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet treatment for overweight and obese patients
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight
Description
Weight reduction in kg
Time Frame
Change from baseline to follow-up at 6 months and 12 months
Secondary Outcome Measure Information:
Title
Dietary habits
Description
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.
Time Frame
Change from baseline to follow-up at 6 months and 12 months
Title
Physical activity
Description
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.
Time Frame
Change from baseline to follow-up at 6 months and 12 months
Title
Psychosocial functioning
Description
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).
Time Frame
Change from baseline to follow-up at 6 months and 12 months
Title
Experiences of the treatment program
Description
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 .
Time Frame
From treatment start to follow-up after treatment ends at 6 months
Title
Experiences of the treatment effects
Description
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.
Time Frame
From baseline to follow-up at 6 months and 12 months
Other Pre-specified Outcome Measures:
Title
Causes of drop-out from treatment
Description
Interviews with participants who finish the treatment prematurely
Time Frame
Within two weeks of the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Jansson, MD, PhD
Organizational Affiliation
Region Örebro County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obesity Unit, Örebro University Hospital, Region Örebro County
City
Örebro
ZIP/Postal Code
703 62
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Internet Treatment for Persons With Overweight or Obesity
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