Effective Weight Maintenance for the Working Age

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effective Weight Maintenance for the Working Age - the Effectivity and Adherence of Three Web-based Weight Maintenance Interventions

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Healthy Weight Coaching
* Behavioral: Individual meetings
* Behavioral: Group meetings


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual<br>HWC protocol + three individual face-to-face sessions via video | Behavioral: Healthy Weight Coaching<br>* Lifestyle intervention based on Healthy Weight Coaching (HWC) 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.<br>Behavioral: Individual meetings<br>* Individual sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.<br>|
| Experimental: Group<br>HWC protocol + three face-to-face group sessions via video | Behavioral: Healthy Weight Coaching<br>* Lifestyle intervention based on Healthy Weight Coaching (HWC) 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.<br>Behavioral: Group meetings<br>* Group sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.<br>|
| Active Comparator: Control<br>Standard HWC protocol | Behavioral: Healthy Weight Coaching<br>* Lifestyle intervention based on Healthy Weight Coaching (HWC) 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of weight loss | Mean weight change in percent | baseline to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorical weight loss | Percent of patients achieving 3-4.9 percent, 5-9.9 percent and >10 percent weight loss | baseline to 36 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. Theoretical range of the overall score is 22-154, higher scores indicating worse outcome. | baseline to 36 months | 
| Eating behaviour | Eating behavior is assessed by the Three Factor Eating Questionnaire (TFEQ). The Three-Factor Eating Questionnaire (TFEQ), a valid 51-item measure of restraint, disinhibition, and hunger subscales. Theoretical range of the overall score is 0-51, higher scores indicating worse outcome. | baseline to 36 months | 
| Perceived working ability | Perceived working ability is assessed by a simple How able do you feel like to manage your job at the moment. The score is measured by a ten point scale (1-10), higher score indicating better outcome. | baseline to 36 months | 
| Glucose metabolism | Concentration of fasting glucose and HbaA1c in a blood sample | baseline to 36 months | 
| Lipid metabolism | Concentration of fasting cholesterol (HDL, LDL, trigly) in a blood sample | baseline to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight management, Occupational health