ECHANGE: EHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss (eCHANGE)

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Weight, Body
• Intervention / Treatment: Other: Behavioral: eCHANGE

Detailed Description

Obesity rates are rapidly increasing and even with diets and interventions aiding weight loss, an alarmingly large percentage of people struggle to maintain the lost weight. In the face of obesity, weight maintenance is therefore arising as a major obstacle and new innovative approaches are called for. Despite the fact that a substantial number of web-based diets, health and fitness focused interventions or "apps" already exist, few focus on weight maintenance, are research based or available post study. In addition, most have yet to show short- or long-term effect and few, if any, are developed together with users (e.g., patients, health care professionals). eHealth solutions may therefore be a "missing link" in supporting self-regulation and motivation for sustainable health behavior change and weight loss maintenance. The aim of this study is to evaluate a person-centered, evidence based interactive eHealth intervention facilitating weight maintenance following initial weight loss during a 3- month feasibility pilot trial.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI 30 or more before weight loss
• 8% 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feasibility and usability intervention trial; Pre-post evaluation of a 3-month pilot-trial of an electronic health (eHealth) intervention	Other: Behavioral: eCHANGE; eCHANGE is an eHealth intervention aiming to support long-term weight maintenance after initial weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight measurement	Baseline and at 3 months post baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three-Factor Eating Questionnaire (TFEQ-R21)	21 item scale to evaluate cognitive restraint, emotional eating and bingeing behaviors	Baseline and at 3 months post baseline
Pittsburgh Sleep Quality Index (PSQI)	A self-reporting questionnaire of 19 individual items, creating 7 components that produce one global score.	Baseline and at 3 months post baseline
System Usability Scale (SUS)	1o item scale measuring usability, with five response options for respondents; from Strongly agree to Strongly disagree. The obtainable score range is 25 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.	At 3 months post baseline
TWente Engagement with Ehealth Technologies Scale (TWEETS)	To measure behavioral, cognitive and affective engagment with a 5 point Likert scale: strongly disagree, disagree, neutral, agree, strongly agree	At 3 months post baseline
The Hospital Anxiety and Depression Scale (HADS) - Assessing change	14 item scale measuring anxiety and depression. Respondents are asked to indicate which of 4 response options (rated from 0-3; score range, 0-42) comes closest to describing how they have been feeling in the previous week for each item. Scores from 0-7 on the subscales are regarded as being in the normal range; a score of 11 or higher indicates a probable presence of a mood disorder, and a score of 8-10 is suggestive of the presence of the state.	At baseline and at 3 months post baseline
RAND Health Related Quality of Life	At baseline and at 3 months post baseline	36 item scale measuring health related quality of life. The RAND-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question
Weight-related Symptom Measure (WRSM)	Patient reported outcome measures that assesses the symptoms that are commonly associated with obesity, next to quality of life, general functional status and well-being.	At baseline and at 3 months post baseline
Treatment Self-Regulation Questionnaire (TSRQ diet and exercise)	A theoretically derived scale which assesses the degree of autonomous self-regulation regarding why people engage or would engage in healthy behavior	At baseline and at 3 months post baseline
Perceived Competence Scale (PCS) (diet and exercise)	A 4-item questionnaire, that assesses participants' feelings of competence about engaging in a healthier behavior (e.g., diet) and participating in a physical activity regularly.	At baseline and at 3 months post baseline

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Mayo Clinic; Sorlandet Hospital HF; The Hospital of Vestfold; University of Twente
• Investigators: Principal Investigator: Lise Solberg Nes, PhD, Head of Department

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): May 10, 2021
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Weight maintenance
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 20/13923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No