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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
213
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.
Otto-Friedrich-University
Bamberg, Bavaria, Germany
LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy
Bochum, North Rhine-Westphalia, Germany
Changes in Physical Activity
The effectiveness of the intervention with regard to physical activity (motion sensors) will be investigated respecting gender-related differences.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Weight Change
The effectiveness of the intervention with regard to weight will be investigated as assessed by BMI.
Time frame: 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 Emotional Competence
The effectiveness of the intervention with regard to subjective feeling of emotional competence (SEK-27) will be investigated respecting gender-related differences.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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