Clinical trial NCT04537988: ECHANGE: EHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss
Official title: ECHANGE: Using EHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight, Body
Keywords: Weight maintenance
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sorlandet Hospital HF
name: University of Twente
name: Mayo Clinic
name: The Hospital of Vestfold
First posted: 2020-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Testing a prototype of an eHealt self-management intervention of long-term weight loss maintenance to evaluate usability and preliminary efficacy.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Efficacy and usability
timeFrame: Baseline and at 3 months post baseline
Secondary outcomes:
measure: Weight
timeFrame: Baseline and at 3 months post baseline
Other outcomes:
measure: Three-Factor Eating Questionnaire (TFEQ-R21)
timeFrame: Baseline and at 3 months post baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and at 3 months post baseline
measure: System Usability Scale (SUS)
timeFrame: At 3 months post baseline
measure: TWente Engagement with Ehealth Technologies Scale (TWEETS)
timeFrame: At 3 months post baseline
measure: The Hospital Anxiety and Depression Scale (HADS) - Assessing change
timeFrame: At baseline and at 3 months post baseline
measure: RAND Health Related Quality of Life
timeFrame: 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
measure: Weight-related Symptom Measure (WRSM)
timeFrame: At baseline and at 3 months post baseline
measure: Treatment Self-Regulation Questionnaire (TSRQ diet and exercise)
timeFrame: At baseline and at 3 months post baseline
measure: Perceived Competence Scale (PCS) (diet and exercise)
timeFrame: At baseline and at 3 months post baseline
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Head of Department
name: Lise Solberg Nes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.