ECHANGE: EHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss

NCT04537988 | Active Not Recruiting

• 1 other identifier: 20/13923
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate an eHealth intervention facilitating weight maintenance following initial weight loss during a 3-month trial (pilot test)

Conditions

Weight, Body

Keywords

Weight maintenance

Outcome Measures

Primary Outcomes (1)

• Efficacy and usability

  Collected data from system use log and from study specific system usefulness questions (use and perceived usefulness)

  Baseline and at 3 months post baseline

Secondary Outcomes (1)

• Weight

  Baseline and at 3 months post baseline

Other Outcomes (9)

• Three-Factor Eating Questionnaire (TFEQ-R21)

  Baseline and at 3 months post baseline

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline and at 3 months post baseline

• System Usability Scale (SUS)

  At 3 months post baseline

Study Arms (1)

Feasibility and usability intervention trial

EXPERIMENTAL

Pre-post evaluation of a 3-month pilot-trial of an electronic health (eHealth) intervention

Other: Behavioral: eCHANGE

Interventions

Behavioral: eCHANGE OTHER

eCHANGE is an eHealth intervention aiming to support long-term weight maintenance after initial weight loss

Feasibility and usability intervention trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 30 or more before weight loss
• % weight reduction or more through conservative methods
• Aim to maintain weight after weight loss or prevent weight gain
• Understand and read the Norwegian languague
• Can access the internet and own a smartphone

You may not qualify if:

• Weight loss through surgery or medication
• Medication to support weight loss or maintenance

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sorlandet Hospital HF: collaborator
• University of Twente: collaborator
• Mayo Clinic: collaborator
• The Hospital of Vestfold: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (2)

• Asbjornsen RA, Hjelmesaeth J, Smedsrod ML, Wentzel J, Ollivier M, Clark MM, van Gemert-Pijnen JEWC, Solberg Nes L. Combining Persuasive System Design Principles and Behavior Change Techniques in Digital Interventions Supporting Long-term Weight Loss Maintenance: Design and Development of eCHANGE. JMIR Hum Factors. 2022 May 27;9(2):e37372. doi: 10.2196/37372.

  PMID: 35622394 DERIVED

• Asbjornsen RA, Wentzel J, Smedsrod ML, Hjelmesaeth J, Clark MM, Solberg Nes L, Van Gemert-Pijnen JEWC. Identifying Persuasive Design Principles and Behavior Change Techniques Supporting End User Values and Needs in eHealth Interventions for Long-Term Weight Loss Maintenance: Qualitative Study. J Med Internet Res. 2020 Nov 30;22(11):e22598. doi: 10.2196/22598.

  PMID: 33252347 DERIVED

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lise Solberg Nes, PhD

  Head of Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Model Details: Testing a prototype of an eHealt self-management intervention of long-term weight loss maintenance to evaluate usability and preliminary efficacy.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: September 3, 2020
• Study Start: November 2, 2020
• Primary Completion: May 10, 2021
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)