Clinical trial NCT04019249: HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting
Official title: HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: eHealth, web-based, internet-based, digital, body weight
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: % weight loss
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Categorical weight loss
timeFrame: baseline to 12 months
measure: Sleep
timeFrame: baseline to 12 months
measure: Health-Related Quality of Life
timeFrame: baseline to 12 months
measure: Psychological Flexibility
timeFrame: baseline to 12 months
measure: Eating behaviour
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
Study officials:
affiliation: Helsinki University Central Hospital
name: Kirsi Pietiläinen, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.