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ObesityNCT04019249

HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting

A study testing Healthy Weight Coaching in people with Obesity, run by Helsinki University Central Hospital at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study evaluates the effectiveness of a web-based obesity management program HealthyWeightCoaching (HWC), within a HealthyWeightHub.fi (HWH) platform. HWC is a 12-month intervention within a real-life clinical setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Healthy Weight Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,000 participants
Where
1 siteFinland
Study dates
1 Oct 2016to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age over 18 years
  • body mass index (BMI) ≥ 25 kg/ m²
  • the possibility to use a computer and /or a smartphone with access to the internet
  • willingness to participate in the digital treatment program

Who cannot join

  • diagnosed severe illness requiring assessment from the specialty care obesity center
  • pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kirsi Pietiläinen, MD-PhD contact

+358505992295

kirsi.pietilainen@helsinki.fi

Finland1 site, 1 recruiting

  • University of Helsinki

    Helsinki

    Kirsi Pietiläinen, +358505992295, kirsi.pietilainen@helsinki.fi

    Recruiting

Other trials in Finland

About this study

This study evaluates the effectiveness of a web-based obesity management program HealthyWeightCoaching (HWC), within a HealthyWeightHub.fi (HWH) platform. HWC is a 12-month intervention within a real-life clinical setting. The program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy.

In addition to the automated, interactive program, HWC includes a personal coach allocated to each patient. The patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in Finland.

Read the detailed description

Obesity is one of the major public health problems globally and it increases the risk of many obesity-associated diseases. 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. New cost-effective and accessible intervention methods are needed.

The modern treatment of obesity is based on behavioral changes that modify one´s daily lifestyle, which, according to recent research, are effective especially in the prevention of diabetes. However, little is known about the utilization and effectiveness of online programs using novel interactive technologies.

The aim of this study is to evaluate the effectiveness of a real-life web-based obesity management program (HealthyWeightCoaching, HWC) on weight loss, health, quality of life, and factors predicting long term success in treating overweight adult patients.

Healthy Weight Coaching is a novel 12-month intervention within a real-life clinical setting. The program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy. The program is structured around weekly exercise modules.

In addition to the automated, interactive program, HWC includes a personal coach allocated to each patient. The patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in Finland. The program is free for the patient to use.

The 12-month intervention is followed by a 5-year monitoring period. Questionnaires on health, quality of life, and lifestyle are collected at 0, 3, 6, 9, and 12-month time points. Body weight is collected by weekly logs. The recruitment is ongoing as the program is currently used in clinical practice.

Conditions
Obesity
Being tested
Healthy Weight Coaching
Keywords
eHealth, web-based, internet-based, digital, body weight
Medical subject headings
Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Weight CoachingBehavioural

    Healthy Weight Coaching 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.

Study groups in NCT04019249
Study groupRoleWhat they receive
Experimental: Healthy Weight CoachingExperimentalIntervention: Healthy Weight Coaching.
Receives: Behavioral: Healthy Weight Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % weight loss

    Mean weight change in %

    Measured: baseline to 12 months

Secondary outcomes (5)

  1. Categorical weight loss

    % patients achieving 3-4.9%, 5-9.9% and >10% weight loss

    Measured: baseline to 12 months

  2. Sleep

    Self-reported sleep variables are measured by a questionnaire that was modified from the Basic Nordic Sleep Questionnaire and The National FINRISK study. Included are questions about sleep duration, chronotype, tiredness, sleep apnoea, and medication.

    Measured: baseline to 12 months

  3. Health-Related Quality of Life

    Health-related quality of life is measured by the RAND36 questionnaire.

    Measured: baseline to 12 months

  4. 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.

    Measured: baseline to 12 months

  5. Eating behaviour

    Eating behavior is assessed by the Three Factor Eating Questionnaire (TFEQ), measuring dietary restraint, disinhibition, and susceptibility to hunger.

    Measured: baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2019
  2. Study start1 Oct 2016
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04019249
Sponsor's protocol ID
HealthyWeightHub.fi
Status last verified
Mar 2022
First submitted
12 Jul 2019
Last updated
18 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • McCann I, Joki A, Suojanen LU, Venalainen MS, Pietilainen KH, Ahola AJ. Disentangling direct and weight-mediated effects of physical activity on health-related quality of life in a 12-month real-world digital lifestyle intervention. Qual Life Res. 2026 Oct 22;35(11):313. doi: 10.1007/s11136-026-04425-3.

    PubMed 42911506

  • Wu ER, Joki A, Venalainen MS, Suojanen LU, Pietilainen KH, Ahola AJ. Alcohol consumption, smoking, and weight loss outcomes: findings from a 12-month digital lifestyle intervention. Eur J Public Health. 2026 Apr 11;36(3):ckag072. doi: 10.1093/eurpub/ckag072.

    PubMed 42154894

  • Mannisto SA, Joki A, Suojanen LU, Venalainen MS, Pietilainen KH, Ahola AJ. Does loneliness impact intentional weight loss? The role of obesity-related disadvantages and comorbidities. Prev Med. 2026 Jan;202:108430. doi: 10.1016/j.ypmed.2025.108430. Epub 2025 Oct 11.

    PubMed 41082943

  • Ahola AJ, Suojanen LU, Joki A, Pietilainen KH. Loneliness and its cross-sectional associations with health, health behaviours, and perceptions in Finnish patients with overweight or obesity taking part in the Healthy Weight Coaching. Prev Med. 2024 Aug;185:108032. doi: 10.1016/j.ypmed.2024.108032. Epub 2024 Jun 6.

    PubMed 38851400

  • Biehl A, Venalainen MS, Suojanen LU, Kupila S, Ahola AJ, Pietilainen KH, Elo LL. Development and validation of a weight-loss predictor to assist weight loss management. Sci Rep. 2023 Nov 24;13(1):20661. doi: 10.1038/s41598-023-47930-y.

    PubMed 38001145

  • Suojanen LU, Ahola AJ, Kupila S, Korpela R, Pietilainen KH. Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. Contemp Clin Trials Commun. 2020 Aug 13;19:100638. doi: 10.1016/j.conctc.2020.100638. eCollection 2020 Sep.

    PubMed 32885090

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Weight Coaching 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Mar 2022. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kirsi Pietiläinen, MD-PhD (+358505992295, kirsi.pietilainen@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% weight loss (time frame: baseline to 12 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 NCT04019249, which also lists 6 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 18 Mar 2022.

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