E66
Conditions
Interventions
Group 1: EASE – weight-neutral group intervention (embodiment, awareness, stigma reduction, exploration)
12 group sessions of 2 hours, bi-weekly over 6 months.
Group 2: Active control group: "Ich nehm` ab" (INA), the conventional weight-loss-focused nutrition education programme of the German Nutrition S
12 group sessions of 2 hours, bi-weekly over 6 months.
Sponsors
Justus-Liebig-Universität Gießen, Professur für Ernährungspsychologie, Institut für Ernährungswissenschaft
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: BMI 25–35 kg/m²; residence in Germany; ability to attend the in-person group sessions in Giessen; sufficient German language skills to complete the questionnaires, understand the study materials and participate in the group sessions; access to a computer or smartphone and basic digital literacy (e.g. ability to complete online surveys).
Exclusion criteria
Exclusion criteria: Use of weight-loss medication or GLP-1 receptor agonists, use of weight-loss medication within the previous 6 months, or intention to start any intensive weight-loss treatment during the intervention period; bariatric surgery within the past 12 months; severe psychiatric illness that may prevent regular and active participation in the group sessions or pose a safety risk to the participant or others (e.g. acute psychosis, severe major depressive episode with suicidal ideation, acute substance use disorder); severe somatic illness that may interfere with participation or present a safety concern (stroke or myocardial infarction within the past 12 months, acute cardiovascular or circulatory conditions, severe heart failure, active cancer or cancer treatment within the past 12 months, medication-treated diabetes, tuberculosis, current use of cytostatics, immunosuppressants or anticoagulants); current pregnancy or breastfeeding, or intention to become pregnant during the intervention period; current nutritional counselling or intention to start nutritional counselling during the intervention period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the EASE pilot trial. Primary feasibility indicator: Recruitment proportion [Time Frame: end of the recruitment period]: proportion of individuals enrolled as participants out of all individuals who passed the telephone pre-screening; documented continuously by the study team in a standardised screening record and evaluated descriptively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary feasibility outcomes: Completion [Time Frame: T1, after the last group session]: proportion of participants completing the post-intervention (T1) assessment. Adherence [Time Frame: end of the 6-month intervention period]: proportion of participants attending at least two thirds (= 8/12) of the sessions of their allocated programme. Other secondary outcomes: Acceptability [Time Frame: after sessions 3, 6 and 9 (TI1–TI3) and at T1]: acceptability of the EASE and INA programmes, assessed at T1 with an 8-item measure based on the Theoretical Framework of Acceptability and at TI1–TI3 with a 3-item session-level acceptability questionnaire. Intervention fidelity [Time Frame: all EASE and INA sessions]: proportion of prescribed manual components delivered per session, assessed with a researcher-developed manual-based fidelity checklist, completed by facilitators after each session and independently by a blinded rater coding a random 20% sample of audio-recorded sessions. Exploratory clinical outcomes [Time Frame: T0 (baseline), T1 (post-intervention), T2 (6-month follow-up)], self-report questionnaires via SoSci Survey; reported descriptively (within-group change and descriptive between-group comparisons): Intuitive eating: Intuitive Eating Scale-3 (IES-3) Mindful eating: Mindful Eating Inventory (MEI) Emotional eating: Salzburg Emotional Eating Scale (SEES) Stress eating: Salzburg Stress Eating Scale (SSES) Positive body image: Body Appreciation Scale-2 (BAS-2) Functionality appreciation: Functionality Appreciation Scale (FAS) Enjoyment of movement: Physical Activity Enjoyment Scale (PACES) Internalized weight stigma: Modified Weight Bias Internalization Scale (WBIS-M) Fat phobia: Fat Phobia Scale (FPS) Quality of life: World Health Organization Quality of Life-BREF (WHOQOL-BREF) Diet quality: Mediterranean Diet Adherence Screener (MEDAS) Physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ) Eati | — |
Countries
Germany
Outcome results
None listed