Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity
- Conditions
- GenderOverweight and ObesityWeight Loss
- Interventions
- Behavioral: Smartphone-based interventional trial
- Registration Number
- NCT04080193
- Lead Sponsor
- Otto-Friedrich-University Bamberg
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- Obesity class I or II with subjectively experienced weight-related impairment and a current will to lose weight.
- Overweight (i.e. BMI between 25 and 29.9 kg/m²) with weight-related health problems and/or visceral adipose tissue and/or high psychosocial weight-related distress with a current will to lose weight.
- Obesity Class III (i.e. BMI >39.9 kg/m²).
- Current (or within the last 12 months) involvement in a structured weight loss intervention.
- Insulin-dependent type 1 diabetes.
- Previous or intended bariatric surgery.
- Current psychotherapeutic treatment of weight-related health problems.
- Weight-enhancing drugs.
- Drugs which promote weight-loss (e.g. anti-obesity drugs).
- Weight-enhancing health problems which are not yet treated.
- Cancerous disease within the last five years.
- Current substance-use disorders, depression, psychosis, suicidal tendency or pregnancy.
- Severe cognitive impairments.
- Insufficient knowledge of the german language.
- Binge-Eating Disorder or Bulimia nervosa.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Smartphone-based interventional trial 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).
- Primary Outcome Measures
Name Time Method Changes in Subjective Illness Representations 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. The effectiveness of the intervention with regard to subjective illness representations (IPQ-R) will be investigated respecting gender-related differences.
Changes in Physical Activity 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. The effectiveness of the intervention with regard to physical activity (motion sensors) will be investigated respecting gender-related differences.
Changes in Eating Behavior 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. The effectiveness of the intervention with regard to eating behavior (DEBQ) will be investigated respecting gender-related differences.
- Secondary Outcome Measures
Name Time Method Weight Change 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. The effectiveness of the intervention with regard to weight will be investigated as assessed by BMI.
Changes in Emotional Competence 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. The effectiveness of the intervention with regard to subjective feeling of emotional competence (SEK-27) will be investigated respecting gender-related differences.
Changes in Weight-Related Life Quality: ORWELL-97 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. The effectiveness of the intervention with regard to weight-related life quality (ORWELL-97) will be investigated respecting gender-related differences.
Changes in Impulsivity 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. The effectiveness of the intervention with regard to impulsivity (BIS-15) will be investigated respecting gender-related differences.
Changes in Self-Efficacy: General-Self-Efficacy-Scale 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. The effectiveness of the intervention with regard to self-efficacy (General-Self-Efficacy-Scale) will be investigated respecting gender-related differences.
Changes in Coping Strategies 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. The effectiveness of the intervention with regard to coping strategies (Brief COPE) will be investigated respecting gender-related differences.
Trial Locations
- Locations (2)
Otto-Friedrich-University
🇩🇪Bamberg, Bavaria, Germany
LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy
🇩🇪Bochum, NRW, Germany