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

Sponsor

Oslo University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04537988

Collaborator

Sorlandet Hospital HF (Other), University of Twente (Other), Mayo Clinic (Other), The Hospital of Vestfold (Other)

Enrollment

Location

Arm

37.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Weight, Body	Other: Behavioral: eCHANGE	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 2, 2020

Actual Primary Completion Date :

May 10, 2021

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Efficacy and usability [Baseline and at 3 months post baseline]
Collected data from system use log and from study specific system usefulness questions (use and perceived usefulness)

Secondary Outcome Measures

Weight [Baseline and at 3 months post baseline]
Weight measurement

Other Outcome Measures

Three-Factor Eating Questionnaire (TFEQ-R21) [Baseline and at 3 months post baseline]
21 item scale to evaluate cognitive restraint, emotional eating and bingeing behaviors
Pittsburgh Sleep Quality Index (PSQI) [Baseline and at 3 months post baseline]
A self-reporting questionnaire of 19 individual items, creating 7 components that produce one global score.
System Usability Scale (SUS) [At 3 months post baseline]
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.
TWente Engagement with Ehealth Technologies Scale (TWEETS) [At 3 months post baseline]
To 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 change [At baseline and at 3 months post baseline]
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.
RAND Health Related Quality of Life [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]
At baseline and at 3 months post baseline
Weight-related Symptom Measure (WRSM) [At baseline and at 3 months post baseline]
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.
Treatment Self-Regulation Questionnaire (TSRQ diet and exercise) [At baseline and at 3 months post baseline]
A 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 baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway

Sponsors and Collaborators

Oslo University Hospital
Sorlandet Hospital HF
University of Twente
Mayo Clinic
The Hospital of Vestfold

Investigators

Principal Investigator: Lise Solberg Nes, PhD, Head of Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lise Solberg Nes, Head of Department, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT04537988

Other Study ID Numbers:

20/13923

First Posted:

Sep 3, 2020

Last Update Posted:

May 12, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lise Solberg Nes, Head of Department, Oslo University Hospital

Weight maintenance

Additional relevant MeSH terms:

Body Weight

Weight Loss

Study Results

No Results Posted as of May 12, 2021