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

Primary Purpose

Weight, Body

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Behavioral: eCHANGE
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight, Body focused on measuring Weight maintenance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility and usability intervention trial

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Weight
Weight measurement

Full Information

First Posted
June 24, 2020
Last Updated
October 10, 2022
Sponsor
Oslo University Hospital
Collaborators
Sorlandet Hospital HF, University of Twente, Mayo Clinic, The Hospital of Vestfold
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1. Study Identification

Unique Protocol Identification Number
NCT04537988
Brief Title
eCHANGE: eHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss
Acronym
eCHANGE
Official Title
eCHANGE: Using eHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Sorlandet Hospital HF, University of Twente, Mayo Clinic, The Hospital of Vestfold

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight, Body
Keywords
Weight maintenance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Testing a prototype of an eHealt self-management intervention of long-term weight loss maintenance to evaluate usability and preliminary efficacy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feasibility and usability intervention trial
Arm Type
Experimental
Arm Description
Pre-post evaluation of a 3-month pilot-trial of an electronic health (eHealth) intervention
Intervention Type
Other
Intervention Name(s)
Behavioral: eCHANGE
Intervention Description
eCHANGE is an eHealth intervention aiming to support long-term weight maintenance after initial weight loss
Primary Outcome Measure Information:
Title
Efficacy and usability
Description
Collected data from system use log and from study specific system usefulness questions (use and perceived usefulness)
Time Frame
Baseline and at 3 months post baseline
Secondary Outcome Measure Information:
Title
Weight
Description
Weight measurement
Time Frame
Baseline and at 3 months post baseline
Other Pre-specified Outcome Measures:
Title
Three-Factor Eating Questionnaire (TFEQ-R21)
Description
21 item scale to evaluate cognitive restraint, emotional eating and bingeing behaviors
Time Frame
Baseline and at 3 months post baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
A self-reporting questionnaire of 19 individual items, creating 7 components that produce one global score.
Time Frame
Baseline and at 3 months post baseline
Title
System Usability Scale (SUS)
Description
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.
Time Frame
At 3 months post baseline
Title
TWente Engagement with Ehealth Technologies Scale (TWEETS)
Description
To measure behavioral, cognitive and affective engagment with a 5 point Likert scale: strongly disagree, disagree, neutral, agree, strongly agree
Time Frame
At 3 months post baseline
Title
The Hospital Anxiety and Depression Scale (HADS) - Assessing change
Description
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.
Time Frame
At baseline and at 3 months post baseline
Title
RAND Health Related Quality of Life
Description
At baseline and at 3 months post baseline
Time Frame
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
Title
Weight-related Symptom Measure (WRSM)
Description
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.
Time Frame
At baseline and at 3 months post baseline
Title
Treatment Self-Regulation Questionnaire (TSRQ diet and exercise)
Description
A theoretically derived scale which assesses the degree of autonomous self-regulation regarding why people engage or would engage in healthy behavior
Time Frame
At baseline and at 3 months post baseline
Title
Perceived Competence Scale (PCS) (diet and exercise)
Description
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.
Time Frame
At baseline and at 3 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Solberg Nes, PhD
Organizational Affiliation
Head of Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35622394
Citation
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.
Results Reference
derived
PubMed Identifier
33252347
Citation
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.
Results Reference
derived

Learn more about this trial

eCHANGE: eHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss

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