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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00016623 | Registry Identifier | German Clinical Trials Register |
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| Name | Class |
|---|---|
| Department of Psychosomatic Medicine, LWL University Hospital Bochum | UNKNOWN |
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The major aim of the proposed study is to develop a gender-sensitive individually tailored add-on intervention that focusses on improving individual gender-specific SIRs (subjective illness representations) in obese or overweight individuals. We will investigate whether this will improve compliance with and long-term success of common weight loss interventions. The effectiveness of this intervention in every-day-life with regard to weight-related behavioral changes and weight loss will be evaluated within a randomized controlled setting.To enhance the applicability of the intervention in every-day-life and its dissemination we plan to develop a smart-phone-based intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The study will be a Smartphone-based interventional trial. To assess the effectiveness of the intervention weight- and eating-related behavior and cognitive and emotional responding as well as body-weight will be assessed using questionnaires and ecological momentary assessment (EMA) for one week at a pre- (T0), post- (T1) and two follow-up-assessments after six (T2) and 12 months (T3). |
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| Control Group | No Intervention | Members of the control group will participate at each assessment. During the intervention phase they will receive treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone-based interventional trial | Behavioral | According to the SIRs the 12-week intervention will contain exercises from three out of six different key modules (e.g. self-efficacy, impulsivity). The remaining modules will be implemented as mini-modules during the end of the intervention phase. The study will be designed gender-sensitive instead of gender-dichotomous. This means that treatment contents will be individualized based on gender-related SIRs and not biological sex. Participants choose between two different styles of presentation for each module and the contents can be deepened within specific exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Physical Activity | The effectiveness of the intervention with regard to physical activity (motion sensors) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Eating Behavior | The effectiveness of the intervention with regard to eating behavior (DEBQ) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Subjective Illness Representations | The effectiveness of the intervention with regard to subjective illness representations (IPQ-R) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | The effectiveness of the intervention with regard to weight will be investigated as assessed by BMI. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in General Life Quality: L-1 | The effectiveness of the intervention with regard to general life quality (L-1) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Steins-Löber, Prof. Dr. | Otto-Friedrich-University Bamberg | Principal Investigator |
| Stephan Herpertz, Prof. Dr. | Department of Psychosomatic Medicine, LWL University Hospital Bochum | Principal Investigator |
| Jörg Wolstein, Prof. Dr. | Otto-Friedrich-University Bamberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otto-Friedrich-University | Bamberg | Bavaria | Germany | |||
| LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34471546 | Background | Prill S, Henning C, Schroeder S, Steins-Loeber S, Wolstein J. Does Weight-Cycling Influence Illness Beliefs in Obesity? A Gender-Sensitive Approach. J Obes. 2021 Aug 21;2021:8861386. doi: 10.1155/2021/8861386. eCollection 2021. | |
| 35211498 | Background | Henning C, Schroeder S, Steins-Loeber S, Wolstein J. Gender and Emotional Representation Matter: Own Illness Beliefs and Their Relationship to Obesity. Front Nutr. 2022 Feb 8;9:799831. doi: 10.3389/fnut.2022.799831. eCollection 2022. |
| Label | URL |
|---|---|
| Study Homepage | View source |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Changes in Emotional Competence |
The effectiveness of the intervention with regard to subjective feeling of emotional competence (SEK-27) will be investigated respecting gender-related differences. |
| The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Impulsivity | The effectiveness of the intervention with regard to impulsivity (BIS-15) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Coping Strategies | The effectiveness of the intervention with regard to coping strategies (Brief COPE) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Weight-Related Life Quality: ORWELL-97 | The effectiveness of the intervention with regard to weight-related life quality (ORWELL-97) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Self-Efficacy: General-Self-Efficacy-Scale | The effectiveness of the intervention with regard to self-efficacy (General-Self-Efficacy-Scale) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Weight Bias Internalization | The effectiveness of the intervention with regard to weight bias internalization (WBI-Scale) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in General Weight Bias | The effectiveness of the intervention with regard to general weight bias (Fat Phobia Scale) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Psychopathology | The effectiveness of the intervention with regard to psychopathology (BSI-10) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Self-Esteem | The effectiveness of the intervention with regard to self-esteem (Rosenberg Self-Esteem Scale) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Food Addiction | The effectiveness of the intervention with regard to food addiction (YFAS) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Media Usage | The potential impact of media usage (OSVe-S) on the effectiveness of the intervention as well as potential changes of media usage behaviour in the course of the intervention will be investigated. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Valuation of perceived discrimination due to physical appearance | The effectiveness of the intervention with regard to subjective valuation of perceived discrimination (POTS) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Social Support | The potential impact of social support (ESSI) on the effectiveness of the intervention as well as potential changes of social support behaviour in the course of the intervention will be investigated. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Impulsive Eating Behaviour | The effectiveness of the intervention with regard to impulsive eating behaviour (subscale FEV) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Changes in Food Related Impulsivity | The effectiveness of the intervention with regard to food related impulsivity (newly developed instrument FRIS) will be investigated respecting gender-related differences. | The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later. |
| Bochum |
| North Rhine-Westphalia |
| Germany |
| 34621227 | Result | Pape M, Herpertz S, Schroeder S, Seiferth C, Farber T, Wolstein J, Steins-Loeber S. Food Addiction and Its Relationship to Weight- and Addiction-Related Psychological Parameters in Individuals With Overweight and Obesity. Front Psychol. 2021 Sep 21;12:736454. doi: 10.3389/fpsyg.2021.736454. eCollection 2021. |
| 40181555 | Derived | Pape M, Herpertz S, Farber T, Seiferth C, Schoemann N, Wolstein J, Steins-Loeber S. Food Addiction in Individuals With Overweight and Obesity Undergoing a 12-Week Long Tailored mHealth Weight Loss Intervention. Eur Eat Disord Rev. 2025 Sep;33(5):931-940. doi: 10.1002/erv.3196. Epub 2025 Apr 3. |
| 39624149 | Derived | Schoemann N, Seiferth C, Pape M, Farber T, Herpertz S, Steins-Loeber S, Wolstein J. Improving Food-Related Inhibitory Control Through an mHealth Intervention-A Secondary Outcome Analysis of an RCT. Obes Sci Pract. 2024 Dec 2;10(6):e70026. doi: 10.1002/osp4.70026. eCollection 2024 Dec. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D012725 | Sexual Behavior |
| D001519 | Behavior |