Internet Treatment for Persons With Overweight or Obesity

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Internet treatment for overweight and obese patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet treatment for overweight and obese patients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, Body Weight