Effective Weight Maintenance for the Working Age

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04785586
• Other study ID #: 200379
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Healthy Weight Coaching
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.
• Individual meetings
Individual sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.
• Group meetings
Group sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.

Locations

Country	Name	City	State
Finland	Occupational Health Helsinki	Helsinki	Uusimaa

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Occupational Health Helsinki, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of weight loss	Mean weight change in percent	baseline to 24 months
Secondary	Categorical weight loss	Percent of patients achieving 3-4.9 percent, 5-9.9 percent and >10 percent weight loss	baseline to 24 months
Secondary	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 24 months
Secondary	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 24 months
Secondary	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 24 months
Secondary	Glucose metabolism	Concentration of fasting glucose and HbaA1c in a blood sample	baseline to 24 months
Secondary	Lipid metabolism	Concentration of fasting cholesterol (HDL, LDL, trigly) in a blood sample	baseline to 24 months