Internet Treatment for Persons With Overweight or Obesity

Overweight and Obesity Clinical Trial

Official title:

Internet Treatment for Overweight and Obese Patients - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150445
• Other study ID #: 272763
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2022
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
Sweden	Obesity Unit, Örebro University Hospital, Region Örebro County	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Causes of drop-out from treatment	Interviews with participants who finish the treatment prematurely	Within two weeks of the end of treatment
Primary	Body weight	Weight reduction in kg	Change from baseline to follow-up at 6 months and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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