Skip to content

Internet Treatment for Persons With Overweight or Obesity

Internet Treatment for Overweight and Obese Patients - a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04150445
Enrollment
22
Registered
2019-11-04
Start date
2019-12-10
Completion date
2021-02-28
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Overweight, Obesity, Body Weight

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.

Interventions

BEHAVIORALInternet 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.

Sponsors

Region Örebro County
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body weightChange from baseline to follow-up at 6 months and 12 monthsWeight reduction in kg

Secondary

MeasureTime frameDescription
Dietary habitsChange from baseline to follow-up at 6 months and 12 monthsChange 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 activityChange from baseline to follow-up at 6 months and 12 monthsChange 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.
Experiences of the treatment programFrom treatment start to follow-up after treatment ends at 6 monthsThe 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 effectsFrom baseline to follow-up at 6 months and 12 monthsThe 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.
Psychosocial functioningChange from baseline to follow-up at 6 months and 12 monthsChange 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).

Other

MeasureTime frameDescription
Causes of drop-out from treatmentWithin two weeks of the end of treatmentInterviews with participants who finish the treatment prematurely

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026