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

May 3, 2022 updated by: Otto-Friedrich-University Bamberg

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Bamberg, Bavaria, Germany
        • Otto-Friedrich-University
    • NRW
      • Bochum, NRW, Germany
        • LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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).
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.
No Intervention: Control Group
Members of the control group will participate at each assessment. During the intervention phase they will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Physical Activity
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.
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.
Changes in Eating Behavior
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.
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.
Changes in Subjective Illness Representations
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Change
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.
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.
Changes in Emotional Competence
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.
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.
Changes in Impulsivity
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.
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.
Changes in Coping Strategies
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.
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.
Changes in Weight-Related Life Quality: ORWELL-97
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.
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.
Changes in Self-Efficacy: General-Self-Efficacy-Scale
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in General Life Quality: L-1
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.
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.
Changes in Weight Bias Internalization
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.
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.
Changes in General Weight Bias
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.
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.
Changes in Psychopathology
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.
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.
Changes in Self-Esteem
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.
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.
Changes in Food Addiction
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.
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.
Media Usage
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.
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.
Valuation of perceived discrimination due to physical appearance
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.
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.
Social Support
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.
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.
Impulsive Eating Behaviour
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.
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.
Changes in Food Related Impulsivity
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otto-Friedrich-University Bamberg

Collaborators

Department of Psychosomatic Medicine, LWL University Hospital Bochum

Investigators

  • Principal Investigator: Sabine Steins-Löber, Prof. Dr., Otto-Friedrich-University Bamberg
  • Principal Investigator: Stephan Herpertz, Prof. Dr., Department of Psychosomatic Medicine, LWL University Hospital Bochum
  • Principal Investigator: Jörg Wolstein, Prof. Dr., Otto-Friedrich-University Bamberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2019

Primary Completion (Actual)

December 22, 2021

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71/02060305
  • DRKS00016623 (Registry Identifier: German Clinical Trials Register)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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