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

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Healthy Weight Coaching

• Registration Number: NCT04019249
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-18
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Healthy Weight Coaching	Healthy Weight Coaching	Intervention: Healthy Weight Coaching.

Primary Outcome Measures

Name	Time	Method
% weight loss	baseline to 12 months	Mean weight change in %

Secondary Outcome Measures

Name	Time	Method
Categorical weight loss	baseline to 12 months	% patients achieving 3-4.9%, 5-9.9% and \>10% weight loss
Sleep	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.
Health-Related Quality of Life	baseline to 12 months	Health-related quality of life is measured by the RAND36 questionnaire.
Eating behaviour	baseline to 12 months	Eating behavior is assessed by the Three Factor Eating Questionnaire (TFEQ), measuring dietary restraint, disinhibition, and susceptibility to hunger.
Psychological Flexibility	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.

Trial Locations

Locations (1)

University of Helsinki; 🇫🇮 Helsinki, Finland