Internet Treatment for Persons With Overweight or Obesity

NCT04150445 | Completed

• 1 other identifier: 272763
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Overweight; Obesity; Body Weight

Outcome Measures

Primary Outcomes (1)

• Body weight

  Weight reduction in kg

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

Secondary Outcomes (5)

• Dietary habits

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

• Physical activity

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

• Psychosocial functioning

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

• Experiences of the treatment program

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

• Experiences of the treatment effects

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

Other Outcomes (1)

• Causes of drop-out from treatment

  Within two weeks of the end of treatment

Study Arms (1)

Internet treatment for overweight and obese patients

EXPERIMENTAL

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

Interventions

Internet treatment for overweight and obese patients 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.

Internet treatment for overweight and obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Obesity Unit, Örebro University Hospital, Region Örebro County

Örebro, 703 62, Sweden

Location

MeSH Terms

Conditions

Overweight; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Jansson, MD, PhD

  Region Örebro County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 4, 2019
• Study Start: December 10, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)