Effective Weight Maintenance for the Working Age

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04785586
Collaborator
Occupational Health Helsinki (Other), University of Helsinki (Other)
120
1
3
56
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Weight Coaching
  • Behavioral: Individual meetings
  • Behavioral: Group meetings
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Effective Weight Maintenance for the Working Age - the Effectivity and Adherence of Three Web-based Weight Maintenance Interventions
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Individual

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

Behavioral: 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.

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

Experimental: Group

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

Behavioral: 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.

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

Active Comparator: Control

Standard HWC protocol

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Percent of weight loss [baseline to 36 months]

    Mean weight change in percent

Secondary Outcome Measures

  1. Categorical weight loss [baseline to 36 months]

    Percent of patients achieving 3-4.9 percent, 5-9.9 percent and >10 percent weight loss

  2. Psychological Flexibility [baseline to 36 months]

    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.

  3. Eating behaviour [baseline to 36 months]

    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.

  4. Perceived working ability [baseline to 36 months]

    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.

  5. Glucose metabolism [baseline to 36 months]

    Concentration of fasting glucose and HbaA1c in a blood sample

  6. Lipid metabolism [baseline to 36 months]

    Concentration of fasting cholesterol (HDL, LDL, trigly) in a blood sample

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Occupational Health Helsinki Helsinki Uusimaa Finland

Sponsors and Collaborators

  • Helsinki University Central Hospital
  • Occupational Health Helsinki
  • University of Helsinki

Investigators

  • Study Director: Siniriikka Männistö, Psy.M./MHS, Occupational Health Helsinki

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kirsi Pietiläinen, Professor in Clinical Metabolism, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT04785586
Other Study ID Numbers:
  • 200379
First Posted:
Mar 8, 2021
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kirsi Pietiläinen, Professor in Clinical Metabolism, Helsinki University Central Hospital

Study Results

No Results Posted as of Aug 19, 2021