Overweight and ObesityI-GENDONCT04080193

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

A study testing Smartphone-based interventional trial in people with Overweight and Obesity and Weight Loss, run by Otto-Friedrich-University Bamberg at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Overweight and Obesity, Weight Loss, Gender
What is being tested?: Smartphone-based interventional trial
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 213 participants
Where: 2 sitesGermany
Study dates: 7 Dec 2019to 28 Feb 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Otto-Friedrich-University
Bamberg, Bavaria
LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy
Bochum, North Rhine-Westphalia

Other trials in Germany

About this study

Official title: 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.

Conditions: Overweight and Obesity, Weight Loss, Gender
Being tested: Smartphone-based interventional trial
Keywords: Gender, Overweight, Obesity, Intervention, Smartphone-App
Medical subject headings: Overweight, Obesity, Weight Loss, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Smartphone-based interventional trialBehavioural
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.

Study groups in NCT04080193
Study group	Role	What they receive
Intervention Group	Experimental	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). Receives: Behavioral: Smartphone-based interventional trial
Control Group	No intervention	Members of the control group will participate at each assessment. During the intervention phase they will receive treatment as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Physical Activity
The effectiveness of the intervention with regard to physical activity (motion sensors) will be investigated respecting gender-related differences.
Measured: 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
The effectiveness of the intervention with regard to eating behavior (DEBQ) will be investigated respecting gender-related differences.
Measured: 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
The effectiveness of the intervention with regard to subjective illness representations (IPQ-R) will be investigated respecting gender-related differences.
Measured: 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 (6)

Weight Change
The effectiveness of the intervention with regard to weight will be investigated as assessed by BMI.
Measured: 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
The effectiveness of the intervention with regard to subjective feeling of emotional competence (SEK-27) will be investigated respecting gender-related differences.
Measured: 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
The effectiveness of the intervention with regard to impulsivity (BIS-15) will be investigated respecting gender-related differences.
Measured: 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
The effectiveness of the intervention with regard to coping strategies (Brief COPE) will be investigated respecting gender-related differences.
Measured: 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
The effectiveness of the intervention with regard to weight-related life quality (ORWELL-97) will be investigated respecting gender-related differences.
Measured: 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
The effectiveness of the intervention with regard to self-efficacy (General-Self-Efficacy-Scale) will be investigated respecting gender-related differences.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 201928 Feb 2022

First posted6 Sep 2019
Study start7 Dec 2019
Primary completion22 Dec 2021
Study completion28 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04080193
Sponsor's protocol ID: 71/02060305
Other IDs: DRKS00016623
Acronym: I-GENDO
Status last verified: May 2022
First submitted: 25 Apr 2019
Last updated: 9 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 34471546
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.
PubMed 35211498
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.
PubMed 34621227
Pape M, Herpertz S, Farber T, Seiferth C, Schoemann N, Wolstein J, Steins-Loeber S. Food Addiction in Individuals With Overweight and Obesity Undergoing a 12-Week Long Tailored mHealth Weight Loss Intervention. Eur Eat Disord Rev. 2025 Sep;33(5):931-940. doi: 10.1002/erv.3196. Epub 2025 Apr 3.
PubMed 40181555
Schoemann N, Seiferth C, Pape M, Farber T, Herpertz S, Steins-Loeber S, Wolstein J. Improving Food-Related Inhibitory Control Through an mHealth Intervention-A Secondary Outcome Analysis of an RCT. Obes Sci Pract. 2024 Dec 2;10(6):e70026. doi: 10.1002/osp4.70026. eCollection 2024 Dec.
PubMed 39624149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity: a Personalized Smartphone App
ClinicalTrials.gov ID: NCT04080193
Acronym / sponsor ID: I-GENDO / 71/02060305
Conditions: Overweight and Obesity, Weight Loss, Gender
Keywords: Gender, Overweight, Obesity, Intervention, Smartphone-App
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: Otto-Friedrich-University BambergUniversity, hospital or other
Collaborators: Department of Psychosomatic Medicine, LWL University Hospital Bochum
Study start: 7 Dec 2019 (actual)
Primary completion: 22 Dec 2021 (actual)
Study completion: 28 Feb 2022 (actual)
First posted: 6 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention Group	Experimental	Behavioral: Smartphone-based interventional trialThe 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).
Control Group	No intervention	–Members of the control group will participate at each assessment. During the intervention phase they will receive treatment as usual.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Smartphone-based interventional trialAccording 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.	Behavioural	Intervention Group

Primary outcome

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.
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.
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.

6 secondary outcomes

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.
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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
Background: PubMed 34471546Prill 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.
Background: PubMed 35211498Henning 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 publication: PubMed 34621227Pape 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.
Derived from this study: PubMed 40181555Pape M, Herpertz S, Farber T, Seiferth C, Schoemann N, Wolstein J, Steins-Loeber S. Food Addiction in Individuals With Overweight and Obesity Undergoing a 12-Week Long Tailored mHealth Weight Loss Intervention. Eur Eat Disord Rev. 2025 Sep;33(5):931-940. doi: 10.1002/erv.3196. Epub 2025 Apr 3.
Derived from this study: PubMed 39624149Schoemann N, Seiferth C, Pape M, Farber T, Herpertz S, Steins-Loeber S, Wolstein J. Improving Food-Related Inhibitory Control Through an mHealth Intervention-A Secondary Outcome Analysis of an RCT. Obes Sci Pract. 2024 Dec 2;10(6):e70026. doi: 10.1002/osp4.70026. eCollection 2024 Dec.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sabine Steins-Löber, Prof. Dr. principal investigator

Otto-Friedrich-University Bamberg

Stephan Herpertz, Prof. Dr. principal investigator

Department of Psychosomatic Medicine, LWL University Hospital Bochum

Jörg Wolstein, Prof. Dr. principal investigator

Otto-Friedrich-University Bamberg

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone-based interventional trial in people with Overweight and Obesity and Weight Loss, run by Otto-Friedrich-University Bamberg at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04080193, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.