Effective Weight Maintenance for the Working Age

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Healthy Weight Coaching; Behavioral: Individual meetings; Behavioral: Group meetings

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland
      • Occupational Health Helsinki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual; HWC protocol + three individual "face-to-face" sessions via video	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.; Behavioral: Individual meetings; Individual sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.
Experimental: Group; HWC protocol + three "face-to-face" group sessions via video	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.; Behavioral: Group meetings; Group sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.
Active Comparator: Control; Standard HWC protocol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of weight loss	Mean weight change in percent	baseline to 24 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 24 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 24 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 24 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 24 months
Glucose metabolism	Concentration of fasting glucose and HbaA1c in a blood sample	baseline to 24 months
Lipid metabolism	Concentration of fasting cholesterol (HDL, LDL, trigly) in a blood sample	baseline to 24 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; Occupational Health Helsinki
• Investigators: Study Director: Siniriikka Männistö, Psy.M./MHS, Occupational Health Helsinki

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Occupational health; Weight management
• Other Study ID Numbers: 200379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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