Internet Treatment for Persons With Overweight or Obesity

NCT ID: NCT04150445

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2021-02-28

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Internet treatment for overweight and obese patients

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Jansson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Örebro County

Locations

Obesity Unit, Örebro University Hospital, Region Örebro County

Örebro, , Sweden

Countries

Sweden

Other Identifiers

272763

Identifier Type: -

Identifier Source: org_study_id