Effective Weight Maintenance for the Working Age

NCT ID: NCT04785586

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individual

HWC protocol + three individual "face-to-face" sessions via video

Group Type: EXPERIMENTAL

Healthy Weight Coaching

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Individual sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.

Group

HWC protocol + three "face-to-face" group sessions via video

Group Type: EXPERIMENTAL

Healthy Weight Coaching

Intervention Type: BEHAVIORAL

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.

Group meetings

Intervention Type: BEHAVIORAL

Group sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.

Control

Standard HWC protocol

Group Type: ACTIVE_COMPARATOR

Healthy Weight Coaching

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Individual meetings

Individual sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.

Intervention Type: BEHAVIORAL

Group meetings

Group sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Occupational Health Helsinki

UNKNOWN

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kirsi Pietiläinen

Professor in Clinical Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siniriikka Männistö, Psy.M./MHS

Role: STUDY_DIRECTOR

Occupational Health Helsinki

Locations

Occupational Health Helsinki

Helsinki, Uusimaa, Finland

Countries

Finland

References

Mannisto SA, Pietilainen KH, Muotka J, Suojanen LU, Lappalainen R, Korpela R. Coach-Assisted eHealth With Group or Individual Support for Employees With Obesity: Randomized Controlled Trial on Weight, Body Composition, and Health Metrics. J Med Internet Res. 2025 Mar 12;27:e60436. doi: 10.2196/60436.

Reference Type: DERIVED

PMID: 40073400 (View on PubMed)

Other Identifiers

200379

Identifier Type: -

Identifier Source: org_study_id