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Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity (I-GENDO)

Primary Purpose

Overweight and Obesity, Weight Loss, Gender

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Smartphone-based interventional trial

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Gender, Overweight, Obesity, Intervention, Smartphone-App

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Otto-Friedrich-University
LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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).

Members of the control group will participate at each assessment. During the intervention phase they will receive treatment as usual.

Outcomes

Primary Outcome Measures

Changes in Physical Activity

The effectiveness of the intervention with regard to physical activity (motion sensors) will be investigated respecting gender-related differences.

Changes in Eating Behavior

The effectiveness of the intervention with regard to eating behavior (DEBQ) will be investigated respecting gender-related differences.

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.

Secondary Outcome Measures

Weight Change

The effectiveness of the intervention with regard to weight will be investigated as assessed by BMI.

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.

Changes in Impulsivity

The effectiveness of the intervention with regard to impulsivity (BIS-15) will be investigated respecting gender-related differences.

Changes in Coping Strategies

The effectiveness of the intervention with regard to coping strategies (Brief COPE) will be investigated respecting gender-related differences.

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.

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.

Full Information

NCT ID

NCT04080193

First Posted

April 25, 2019

Last Updated

May 3, 2022

Sponsor

Otto-Friedrich-University Bamberg

Collaborators

Department of Psychosomatic Medicine, LWL University Hospital Bochum

1. Study Identification

Unique Protocol Identification Number

NCT04080193

Brief Title

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

Acronym

I-GENDO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 7, 2019 (Actual)

Primary Completion Date

December 22, 2021 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otto-Friedrich-University Bamberg

Collaborators

Department of Psychosomatic Medicine, LWL University Hospital Bochum

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity, Weight Loss, Gender

Keywords

Gender, Overweight, Obesity, Intervention, Smartphone-App

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

213 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Members of the control group will participate at each assessment. During the intervention phase they will receive treatment as usual.

Intervention Type

Behavioral

Intervention Name(s)

Smartphone-based interventional trial

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in Physical Activity

Description

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.

Title

Changes in Eating Behavior

Description

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.

Title

Changes in Subjective Illness Representations

Description

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.

Secondary Outcome Measure Information:

Title

Weight Change

Description

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.

Title

Changes in Emotional Competence

Description

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.

Title

Changes in Impulsivity

Description

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.

Title

Changes in Coping Strategies

Description

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.

Title

Changes in Weight-Related Life Quality: ORWELL-97

Description

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.

Title

Changes in Self-Efficacy: General-Self-Efficacy-Scale

Description

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.

Other Pre-specified Outcome Measures:

Title

Changes in General Life Quality: L-1

Description

The effectiveness of the intervention with regard to general life quality (L-1) 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.

Title

Changes in Weight Bias Internalization

Description

The effectiveness of the intervention with regard to weight bias internalization (WBI-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.

Title

Changes in General Weight Bias

Description

The effectiveness of the intervention with regard to general weight bias (Fat Phobia 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.

Title

Changes in Psychopathology

Description

The effectiveness of the intervention with regard to psychopathology (BSI-10) 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.

Title

Changes in Self-Esteem

Description

The effectiveness of the intervention with regard to self-esteem (Rosenberg Self-Esteem 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.

Title

Changes in Food Addiction

Description

The effectiveness of the intervention with regard to food addiction (YFAS) 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.

Title

Media Usage

Description

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.

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.

Title

Valuation of perceived discrimination due to physical appearance

Description

The effectiveness of the intervention with regard to subjective valuation of perceived discrimination (POTS) 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.

Title

Social Support

Description

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.

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.

Title

Impulsive Eating Behaviour

Description

The effectiveness of the intervention with regard to impulsive eating behaviour (subscale FEV) 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.

Title

Changes in Food Related Impulsivity

Description

The effectiveness of the intervention with regard to food related impulsivity (newly developed instrument FRIS) 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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabine Steins-Löber, Prof. Dr.

Organizational Affiliation

Otto-Friedrich-University Bamberg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stephan Herpertz, Prof. Dr.

Organizational Affiliation

Department of Psychosomatic Medicine, LWL University Hospital Bochum

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jörg Wolstein, Prof. Dr.

Organizational Affiliation

Otto-Friedrich-University Bamberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Otto-Friedrich-University

City

Bamberg

State/Province

Bavaria

Country

Germany

Facility Name

LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy

City

Bochum

State/Province

NRW

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

34471546

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.

Results Reference

background

PubMed Identifier

35211498

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.

Results Reference

background

PubMed Identifier

34621227

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.

Results Reference

result

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

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