Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity

Overweight and Obesity Clinical Trial

— I-GENDO  

Official title:

Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity: a Personalized Smartphone App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080193
• Other study ID #: 71/02060305
• Secondary ID: DRKS00016623
• Status: Completed
• Phase: N/A
• Start date: December 7, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: Otto-Friedrich-University Bamberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: February 28, 2022
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Gender
• Obesity
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Smartphone-based interventional trial
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.

Locations

Country	Name	City	State
Germany	Otto-Friedrich-University	Bamberg	Bavaria
Germany	LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy	Bochum	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Otto-Friedrich-University Bamberg	Department of Psychosomatic Medicine, LWL University Hospital Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

Pape M, Herpertz S, Schroeder S, Seiferth C, Färber 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;12:736 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Study Homepage