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NCT Number: NCT04019249

HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting

This study evaluates the effectiveness of a web-based obesity management program HealthyWeightCoaching (HWC), within a HealthyWeightHub.fi (HWH) platform. HWC is a 12-month intervention within a real-life clinical setting. The program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy.

In addition to the automated, interactive program, HWC includes a personal coach allocated to each patient. The patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in Finland.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases 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

About this study

Obesity is one of the major public health problems globally and it increases the risk of many obesity-associated diseases. Treatment of obesity requires long-term interventions, but nevertheless, it is challenging to provide long-term treatment when resources in real-life health care systems are limited. New cost-effective and accessible intervention methods are needed.

The modern treatment of obesity is based on behavioral changes that modify one´s daily lifestyle, which, according to recent research, are effective especially in the prevention of diabetes. However, little is known about the utilization and effectiveness of online programs using novel interactive technologies.

The aim of this study is to evaluate the effectiveness of a real-life web-based obesity management program (HealthyWeightCoaching, HWC) on weight loss, health, quality of life, and factors predicting long term success in treating overweight adult patients.

Healthy Weight Coaching is a novel 12-month intervention within a real-life clinical setting. The program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy. The program is structured around weekly exercise modules.

In addition to the automated, interactive program, HWC includes a personal coach allocated to each patient. The patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in Finland. The program is free for the patient to use.

The 12-month intervention is followed by a 5-year monitoring period. Questionnaires on health, quality of life, and lifestyle are collected at 0, 3, 6, 9, and 12-month time points. Body weight is collected by weekly logs. The recruitment is ongoing as the program is currently used in clinical practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age over 18 years
  • body mass index (BMI) ≥ 25 kg/ m²
  • the possibility to use a computer and /or a smartphone with access to the internet
  • willingness to participate in the digital treatment program

Exclusion criteria

  • diagnosed severe illness requiring assessment from the specialty care obesity center
  • pregnancy or breastfeeding

Treatment and study plan

Healthy Weight Coaching

Behavioral

Healthy Weight Coaching is a 52 week long web-based weight loss program consisting of weekly modules, exercises, peer support, and one-on-one coaching. It encompasses themes such as diet, physical activity, coping with stress, sleep, and general health.

Primary outcomes

  1. % weight loss

    Time frame: baseline to 12 months

    Mean weight change in %

Secondary outcomes

  1. Categorical weight loss

    Time frame: baseline to 12 months

    % patients achieving 3-4.9%, 5-9.9% and >10% weight loss

  2. Sleep

    Time frame: baseline to 12 months

    Self-reported sleep variables are measured by a questionnaire that was modified from the Basic Nordic Sleep Questionnaire and The National FINRISK study. Included are questions about sleep duration, chronotype, tiredness, sleep apnoea, and medication.

  3. Health-Related Quality of Life

    Time frame: baseline to 12 months

    Health-related quality of life is measured by the RAND36 questionnaire.

  4. Psychological Flexibility

    Time frame: baseline to 12 months

    Psychological flexibility is assessed by the Acceptance and Action Questionnaire for Weight (AAQW). It is a 22-item, Likert-type scale that measures acceptance of weight related thoughts and feelings with valued actions.

  5. Eating behaviour

    Time frame: baseline to 12 months

    Eating behavior is assessed by the Three Factor Eating Questionnaire (TFEQ), measuring dietary restraint, disinhibition, and susceptibility to hunger.

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsi Pietiläinen, MD-PhD

CONTACT

[email protected]

+358505992295

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Jul 15, 2019
Registry last updated
Mar 18, 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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