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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Healthy Weight Coaching

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 Type: Interventional
• Enrollment (Anticipated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirsi Pietiläinen, MD-PhD; Phone Number: +358505992295; Email: kirsi.pietilainen@helsinki.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • University of Helsinki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Healthy Weight Coaching; Intervention: Healthy Weight Coaching.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% weight loss	Mean weight change in %	baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Categorical weight loss	% patients achieving 3-4.9%, 5-9.9% and >10% weight loss	baseline to 12 months
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
Health-Related Quality of Life	Health-related quality of life is measured by the RAND36 questionnaire.	baseline to 12 months
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
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Kirsi Pietiläinen, MD-PhD, Helsinki University Central Hospital

Publications and helpful links

General Publications

• Suojanen LU, Ahola AJ, Kupila S, Korpela R, Pietilainen KH. Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. Contemp Clin Trials Commun. 2020 Aug 13;19:100638. doi: 10.1016/j.conctc.2020.100638. eCollection 2020 Sep.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: eHealth, web-based, internet-based, digital, body weight
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: HealthyWeightHub.fi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No