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

Weight, Body Clinical Trial

— eCHANGE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04537988
• Other study ID #: 20/13923
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss
• Weight, Body

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	Mayo Clinic, Sorlandet Hospital HF, The Hospital of Vestfold, University of Twente

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Pittsburgh Sleep Quality Index (PSQI)	A self-reporting questionnaire of 19 individual items, creating 7 components that produce one global score.	Baseline and at 3 months post baseline
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	Weight	Weight measurement	Baseline and at 3 months post baseline