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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-07

Study Completion Date

2022-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Overweight and Obesity Weight Loss Gender

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Smartphone-based interventional trial

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No