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NCT Number: NCT04537988

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

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)

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Weight, Body Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral: eCHANGE

Other

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

Primary outcomes

  1. Efficacy and usability

    Time frame: 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 outcomes

  1. Weight

    Time frame: Baseline and at 3 months post baseline

    Weight measurement

Other outcomes

  1. Three-Factor Eating Questionnaire (TFEQ-R21)

    Time frame: Baseline and at 3 months post baseline

    21 item scale to evaluate cognitive restraint, emotional eating and bingeing behaviors

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and at 3 months post baseline

    A self-reporting questionnaire of 19 individual items, creating 7 components that produce one global score.

  3. System Usability Scale (SUS)

    Time frame: 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.

  4. TWente Engagement with Ehealth Technologies Scale (TWEETS)

    Time frame: 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

  5. The Hospital Anxiety and Depression Scale (HADS) - Assessing change

    Time frame: 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.

  6. RAND Health Related Quality of Life

    Time frame: 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

  7. Weight-related Symptom Measure (WRSM)

    Time frame: 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.

  8. Treatment Self-Regulation Questionnaire (TSRQ diet and exercise)

    Time frame: 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

  9. Perceived Competence Scale (PCS) (diet and exercise)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: eCHANGE

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Sep 3, 2020
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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