NCT04019249

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
55mo left

Started Oct 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2016Dec 2030

Study Start

First participant enrolled

October 1, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

14.3 years

First QC Date

July 12, 2019

Last Update Submit

March 17, 2022

Conditions

Obesity

Keywords

eHealth, web-based, internet-based, digital, body weight

Outcome Measures

Primary Outcomes (1)

  • % weight loss

    Mean weight change in %

    baseline to 12 months

Secondary Outcomes (5)

  • Categorical weight loss

    baseline to 12 months

  • Sleep

    baseline to 12 months

  • Health-Related Quality of Life

    baseline to 12 months

  • Psychological Flexibility

    baseline to 12 months

  • Eating behaviour

    baseline to 12 months

Study Arms (1)

Experimental: Healthy Weight Coaching

EXPERIMENTAL

Intervention: Healthy Weight Coaching.

Behavioral: Healthy Weight Coaching

Interventions

Healthy Weight CoachingBEHAVIORAL

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.

Experimental: Healthy Weight Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki

Helsinki, Finland

RECRUITING

Related Publications (4)

  • 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.

    PMID: 41082943DERIVED

  • 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.

    PMID: 38851400DERIVED

  • 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.

    PMID: 38001145DERIVED

  • 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.

    PMID: 32885090DERIVED

Related Links

MeSH Terms

Conditions

ObesityBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kirsi Pietiläinen, MD-PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsi Pietiläinen, MD-PhD

CONTACT

+358505992295kirsi.pietilainen@helsinki.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 15, 2019

Study Start

October 1, 2016

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

FI(1)