Clinical trial NCT04080193: Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity
Official title: Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity: a Personalized Smartphone App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Weight Loss
Gender
Keywords: Gender
Overweight
Obesity
Intervention
Smartphone-App
Lead sponsor: Otto-Friedrich-University Bamberg
Sponsor class: OTHER
Collaborators: name: Department of Psychosomatic Medicine, LWL University Hospital Bochum
First posted: 2019-09-06
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Obesity class I or II with subjectively experienced weight-related impairment and a current will to lose weight.
2. 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.

Exclusion Criteria:

1. Obesity Class III (i.e. BMI \>39.9 kg/m²).
2. Current (or within the last 12 months) involvement in a structured weight loss intervention.
3. Insulin-dependent type 1 diabetes.
4. Previous or intended bariatric surgery.
5. Current psychotherapeutic treatment of weight-related health problems.
6. Weight-enhancing drugs.
7. Drugs which promote weight-loss (e.g. anti-obesity drugs).
8. Weight-enhancing health problems which are not yet treated.
9. Cancerous disease within the last five years.
10. Current substance-use disorders, depression, psychosis, suicidal tendency or pregnancy.
11. Severe cognitive impairments.
12. Insufficient knowledge of the german language.
13. Binge-Eating Disorder or Bulimia nervosa.

Primary outcomes:
measure: Changes in Physical Activity
timeFrame: 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: Changes in Eating Behavior
timeFrame: 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: Changes in Subjective Illness Representations
timeFrame: 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.
Secondary outcomes:
measure: Weight Change
timeFrame: 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: Changes in Emotional Competence
timeFrame: 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: Changes in Impulsivity
timeFrame: 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: Changes in Coping Strategies
timeFrame: 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: Changes in Weight-Related Life Quality: ORWELL-97
timeFrame: 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: Changes in Self-Efficacy: General-Self-Efficacy-Scale
timeFrame: 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.
Other outcomes:
measure: Changes in General Life Quality: L-1
timeFrame: 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: Changes in Weight Bias Internalization
timeFrame: 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: Changes in General Weight Bias
timeFrame: 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: Changes in Psychopathology
timeFrame: 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: Changes in Self-Esteem
timeFrame: 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: Changes in Food Addiction
timeFrame: 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: Media Usage
timeFrame: 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: Valuation of perceived discrimination due to physical appearance
timeFrame: 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: Social Support
timeFrame: 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: Impulsive Eating Behaviour
timeFrame: 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: Changes in Food Related Impulsivity
timeFrame: 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.
Locations:
city: Bamberg
country: Germany
facility: Otto-Friedrich-University
state: Bavaria
city: Bochum
country: Germany
facility: LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy
state: NRW
Study officials:
affiliation: Otto-Friedrich-University Bamberg
name: Sabine Steins-Löber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychosomatic Medicine, LWL University Hospital Bochum
name: Stephan Herpertz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Otto-Friedrich-University Bamberg
name: Jörg Wolstein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.