Clinical trial NCT04785586: Effective Weight Maintenance for the Working Age
Official title: Effective Weight Maintenance for the Working Age - the Effectivity and Adherence of Three Web-based Weight Maintenance Interventions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Weight management
Occupational health
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Occupational Health Helsinki
name: University of Helsinki
First posted: 2021-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients are randomized into three groups all of which include the HealthyWeightCoaching (HWC) platform. In addition, group 1 will be offered three individual face-to-face sessions via video and group 2 three group face-to-face sessions via video. Group 3 acts as the control group offering the basic HWC protocol.
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effectiveness and adherence of three web-based weight management interventions, all based on the HealthyWeightCoaching (HWC) within a HealthyWeightHub.fi (HWH) platform. HWC is a 12-month web-based intervention including information and exercises to promote weight loss. Each patient is allocated a personal coach to encourage progress on the platform.

In the current setting, the investigators study how minimal added support will affect the effectiveness and adherence of the web-based program. The patients are randomized into three groups all of which include the HWC platform. In addition, group 1 will be offered three individual face-to-face sessions via video and group 2 three group face-to-face sessions via video. Group 3 acts as the control group offering the basic HWC protocol.

The patients (target n=120) are enrolled from the occupational health of the city of Helsinki.

Detailed description: Obesity is one of the major public health problems globally, affecting an ever-increasing proportion of working age adults. In addition of increasing the risk of many obesity-associated diseases, obesity is associated to impaired ability to work, making it a relevant occupational health concern. 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. To that need, new cost-effective and accessible intervention methods are created. One of these is the a real-life web-based obesity management program HealthyWeightCoaching (HWC).

HWC has shown promising results in obesity management, but alike in other fully virtual interventions, one of the challenges has been adherence. Creating hybrid-models by addition of face-to-face contacts to the web-based structure, has been shown to improve adherence and therefore the effectiveness of the intervention. However, data on hybrid interventions for weight management is still scarce and calls for further research.

In the current setting, the investigators study how minimal added support will affect the effectiveness and adherence of the web-based program. The patients are randomized into three groups all of which include the HWC platform. In addition, group 1 will be offered three individual face-to-face sessions via video and group 2 three group face-to-face sessions via video. Group 3 acts as the control group offering the basic HWC protocol.

Data on health and lifestyle are collected at 0, 6, 12 month time points. The 12-month intervention is followed by a 5 year monitoring period. The data collection includes questionnaires, measurements and laboratory tests.

The patients (target n=120) are enrolled from the occupational health of the city of Helsinki. The participation is free for the patient.

Eligibility criteria: Inclusion Criteria:

* working age
* body mass index (BMI) 30-40 kg/ m²
* the possibility to use a computer and /or a smartphone with access to the internet
* willingness to participate in the treatment program
* sufficient Finnish language

Exclusion Criteria:

* diagnosed severe illness (incl. mental illnesses)
* pregnancy or breastfeeding
* simultaneous participation in another weight loss program
* remarkable changes in weight (+/- 5kg) in the past 3 months
* bariatric operation (past or upcoming)

Primary outcomes:
measure: Percent of weight loss
timeFrame: baseline to 24 months
Secondary outcomes:
measure: Categorical weight loss
timeFrame: baseline to 24 months
measure: Psychological Flexibility
timeFrame: baseline to 24 months
measure: Eating behaviour
timeFrame: baseline to 24 months
measure: Perceived working ability
timeFrame: baseline to 24 months
measure: Glucose metabolism
timeFrame: baseline to 24 months
measure: Lipid metabolism
timeFrame: baseline to 24 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Occupational Health Helsinki
state: Uusimaa
Study officials:
affiliation: Occupational Health Helsinki
name: Siniriikka Männistö, Psy.M./MHS
role: STUDY_DIRECTOR
References: