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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04537988
Acronym
eCHANGE
Enrollment
60
Registered
2020-09-03
Start date
2020-11-02
Completion date
2025-12-31
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight, Body

Keywords

Weight maintenance

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.

Interventions

OTHERBehavioral: eCHANGE

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

Sponsors

Sorlandet Hospital HF
CollaboratorOTHER_GOV
University of Twente
CollaboratorOTHER
Mayo Clinic
CollaboratorOTHER
The Hospital of Vestfold
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy and usabilityBaseline and at 3 months post baselineCollected data from system use log and from study specific system usefulness questions (use and perceived usefulness)

Secondary

MeasureTime frameDescription
WeightBaseline and at 3 months post baselineWeight measurement

Other

MeasureTime frameDescription
System Usability Scale (SUS)At 3 months post baseline1o 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.
TWente Engagement with Ehealth Technologies Scale (TWEETS)At 3 months post baselineTo measure behavioral, cognitive and affective engagment with a 5 point Likert scale: strongly disagree, disagree, neutral, agree, strongly agree
The Hospital Anxiety and Depression Scale (HADS) - Assessing changeAt baseline and at 3 months post baseline14 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.
Three-Factor Eating Questionnaire (TFEQ-R21)Baseline and at 3 months post baseline21 item scale to evaluate cognitive restraint, emotional eating and bingeing behaviors
Weight-related Symptom Measure (WRSM)At baseline and at 3 months post baselinePatient reported outcome measures that assesses the symptoms that are commonly associated with obesity, next to quality of life, general functional status and well-being.
Treatment Self-Regulation Questionnaire (TSRQ diet and exercise)At baseline and at 3 months post baselineA theoretically derived scale which assesses the degree of autonomous self-regulation regarding why people engage or would engage in healthy behavior
Perceived Competence Scale (PCS) (diet and exercise)At baseline and at 3 months post baselineA 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.
RAND Health Related Quality of Life36 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 questionAt baseline and at 3 months post baseline
Pittsburgh Sleep Quality Index (PSQI)Baseline and at 3 months post baselineA self-reporting questionnaire of 19 individual items, creating 7 components that produce one global score.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026