NCT04785586

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 10, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

4.1 years

First QC Date

February 10, 2021

Last Update Submit

January 24, 2024

Conditions

Keywords

Weight managementOccupational health

Outcome Measures

Primary Outcomes (1)

  • Percent of weight loss

    Mean weight change in percent

    baseline to 24 months

Secondary Outcomes (6)

  • Categorical weight loss

    baseline to 24 months

  • Psychological Flexibility

    baseline to 24 months

  • Eating behaviour

    baseline to 24 months

  • Perceived working ability

    baseline to 24 months

  • Glucose metabolism

    baseline to 24 months

  • +1 more secondary outcomes

Study Arms (3)

Individual

EXPERIMENTAL

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

Behavioral: Healthy Weight CoachingBehavioral: Individual meetings

Group

EXPERIMENTAL

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

Behavioral: Healthy Weight CoachingBehavioral: Group meetings

Control

ACTIVE COMPARATOR

Standard HWC protocol

Behavioral: Healthy Weight Coaching

Interventions

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.

ControlGroupIndividual

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

Individual
Group meetingsBEHAVIORAL

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

Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Occupational Health Helsinki

Helsinki, Uusimaa, Finland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Siniriikka Männistö, Psy.M./MHS

    Occupational Health Helsinki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Clinical Metabolism

Study Record Dates

First Submitted

February 10, 2021

First Posted

March 8, 2021

Study Start

April 1, 2021

Primary Completion

May 1, 2025

Study Completion

December 1, 2025

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations