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| Name | Class |
|---|---|
| Sorlandet Hospital HF | OTHER_GOV |
| University of Twente | OTHER |
| Mayo Clinic | OTHER |
| The Hospital of Vestfold |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility and usability intervention trial | Experimental | Pre-post evaluation of a 3-month pilot-trial of an electronic health (eHealth) intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: eCHANGE | Other | eCHANGE is an eHealth intervention aiming to support long-term weight maintenance after initial weight loss |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight measurement | Baseline and at 3 months post baseline |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lise Solberg Nes, PhD | Head of Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35622394 | Derived | 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. | |
| 33252347 |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
Testing a prototype of an eHealt self-management intervention of long-term weight loss maintenance to evaluate usability and preliminary efficacy.
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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 |
| 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. |