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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04019249
• Other study ID #: HealthyWeightHub.fi
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2022
• Source: Helsinki University Central Hospital
• Contact: Kirsi Pietiläinen, MD-PhD
• Phone: +358505992295
• Email: kirsi.pietilainen[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Healthy Weight Coaching
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.

Locations

Country	Name	City	State
Finland	University of Helsinki	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% weight loss	Mean weight change in %	baseline to 12 months
Secondary	Categorical weight loss	% patients achieving 3-4.9%, 5-9.9% and >10% weight loss	baseline to 12 months
Secondary	Sleep	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.	baseline to 12 months
Secondary	Health-Related Quality of Life	Health-related quality of life is measured by the RAND36 questionnaire.	baseline to 12 months
Secondary	Psychological Flexibility	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.	baseline to 12 months
Secondary	Eating behaviour	Eating behavior is assessed by the Three Factor Eating Questionnaire (TFEQ), measuring dietary restraint, disinhibition, and susceptibility to hunger.	baseline to 12 months

External Links

•   The HealthyWeightHub portal, into which the HealthyWeightCoaching program is embedded (in Finnish and Swedish only)