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Completed

NCT Number: NCT04080193

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

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Body Weight Changes Coitus Gender Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Otto-Friedrich-University, Bamberg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Otto-Friedrich-University Bamberg

Other

Collaborators

  • Department of Psychosomatic Medicine, LWL University Hospital Bochum

Registry information

Official study title

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

Acronym: I-GENDO

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 6, 2019
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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