ObesityNCT04785586
Effective Weight Maintenance for the Working Age
A study testing Healthy Weight Coaching, Individual meetings and Group meetings in people with Obesity, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Weight Coaching, Individual meetings and Group meetings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 1 Apr 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Healthy Weight Coaching, Individual meetings, Group meetings
- Keywords
- Weight management, Occupational health
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Weight CoachingBehavioural
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 meetingsBehavioural
Individual sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.
Group meetingsBehavioural
Group sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.
| Study group | Role | What they receive |
|---|---|---|
| Individual | Experimental | HWC protocol + three individual "face-to-face" sessions via video Receives: Behavioral: Healthy Weight Coaching; Behavioral: Individual meetings |
| Group | Experimental | HWC protocol + three "face-to-face" group sessions via video Receives: Behavioral: Healthy Weight Coaching; Behavioral: Group meetings |
| Control | Active comparator | Standard HWC protocol Receives: Behavioral: Healthy Weight Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of weight loss
Mean weight change in percent
Measured: baseline to 24 months
Secondary outcomes (6)
Categorical weight loss
Percent of patients achieving 3-4.9 percent, 5-9.9 percent and >10 percent weight loss
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 24 months
Glucose metabolism
Concentration of fasting glucose and HbaA1c in a blood sample
Measured: baseline to 24 months
Lipid metabolism
Concentration of fasting cholesterol (HDL, LDL, trigly) in a blood sample
Measured: baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Apr 2021
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Occupational Health Helsinki, University of Helsinki
- Responsible party
- Principal investigator, Kirsi Pietiläinen, Helsinki University Central Hospital
- Investigators
- Siniriikka Männistö, Psy.M./MHS, Study director, Occupational Health Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785586
- Sponsor's protocol ID
- 200379
- Status last verified
- Jan 2024
- First submitted
- 10 Feb 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mannisto SA, Muotka J, Suojanen LU, Lappalainen R, Pietilainen KH, Korpela R. Longitudinal associations of depressive and burnout symptoms with eating behavior and physical activity in occupational health clients with obesity. Health Psychol Behav Med. 2026 Aug 5;14(1):2700076. doi: 10.1080/21642850.2026.2700076. eCollection 2026.
PubMed 42564923Mannisto 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.
PubMed 40073400
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Weight Maintenance for the Working Age - the Effectivity and Adherence of Three Web-based Weight Maintenance Interventions
- ClinicalTrials.gov ID
- NCT04785586
- Acronym / sponsor ID
- 200379
- Conditions
- Obesity
- Keywords
- Weight management, Occupational health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Occupational Health Helsinki, University of Helsinki
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individual | Experimental | Behavioral: Healthy Weight Coaching, Behavioral: Individual meetingsHWC protocol + three individual "face-to-face" sessions via video |
| Group | Experimental | Behavioral: Healthy Weight Coaching, Behavioral: Group meetingsHWC protocol + three "face-to-face" group sessions via video |
| Control | Active comparator | Behavioral: Healthy Weight CoachingStandard HWC protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Weight CoachingLifestyle 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. | Behavioural | Control, Group, Individual |
| Individual meetingsIndividual sessions via video, offered to the participant at three (3) different time points during the 12 month intervention. | Behavioural | Individual |
| Group meetingsGroup sessions via video, offered to the participant at three (3) different time points during the 12 month intervention. | Behavioural | Group |
Primary outcome
Percent of weight loss
Time frame: baseline to 24 months
Mean weight change in percent
6 secondary outcomes
Categorical weight loss
Time frame: baseline to 24 months
Psychological Flexibility
Time frame: baseline to 24 months
Eating behaviour
Time frame: baseline to 24 months
Perceived working ability
Time frame: baseline to 24 months
Glucose metabolism
Time frame: baseline to 24 months
Lipid metabolism
Time frame: baseline to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 42564923Mannisto SA, Muotka J, Suojanen LU, Lappalainen R, Pietilainen KH, Korpela R. Longitudinal associations of depressive and burnout symptoms with eating behavior and physical activity in occupational health clients with obesity. Health Psychol Behav Med. 2026 Aug 5;14(1):2700076. doi: 10.1080/21642850.2026.2700076. eCollection 2026.
- Derived from this study: PubMed 40073400Mannisto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siniriikka Männistö, Psy.M./MHS study director
Occupational Health Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Weight Coaching, Individual meetings and Group meetings in people with Obesity, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of weight loss (time frame: baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04785586, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.