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Completed

NCT Number: NCT04150445

Internet Treatment for Persons With Overweight or Obesity

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Obesity Unit, Örebro University Hospital, Region Örebro County

Örebro, 703 62, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Body weight

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

    Weight reduction in kg

Secondary outcomes

  1. Dietary habits

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

    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.

  2. Physical activity

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

    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.

  3. Psychosocial functioning

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

    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).

  4. Experiences of the treatment program

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

    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 .

  5. Experiences of the treatment effects

    Time frame: From baseline to follow-up at 6 months and 12 months

    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.

Other outcomes

  1. Causes of drop-out from treatment

    Time frame: Within two weeks of the end of treatment

    Interviews with participants who finish the treatment prematurely

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

Internet Treatment for Overweight and Obese Patients - a Pilot Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2019
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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