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

NCT04080193 | Completed

• 2 other identifiers: 71/02060305DRKS00016623
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity; Weight Loss; Gender

Keywords

Gender; Overweight; Obesity; Intervention; Smartphone-App

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (6)

• Weight Change

  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 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 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 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 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 (11)

• Changes in General Life Quality: L-1

  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

  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

  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.

Study Arms (2)

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).

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.

Interventions

Smartphone-based interventional trial BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otto-Friedrich-University Bamberg: lead
• Department of Psychosomatic Medicine, LWL University Hospital Bochum: collaborator

Study Sites (2)

Otto-Friedrich-University

Bamberg, Bavaria, Germany

Location

LWL-University Hospital Department of Psychosomatic Medicine and Psychotherapy

Bochum, North Rhine-Westphalia, Germany

Location

Related Publications (5)

• 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.

  PMID: 34471546 BACKGROUND

• 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.

  PMID: 35211498 BACKGROUND

• 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.

  PMID: 34621227 RESULT

• 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.

  PMID: 40181555 DERIVED

• 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.

  PMID: 39624149 DERIVED

Related Links

• Study Homepage

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Coitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Sexual Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: September 6, 2019
• Study Start: December 7, 2019
• Primary Completion: December 22, 2021
• Study Completion: February 28, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

DE (2)