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

Otto-Friedrich-University Bamberg

Status: Completed

Conditions: Weight Loss; Overweight and Obesity; Gender

Treatments: Behavioral: Smartphone-based interventional trial

Study type: Interventional

Funder types: Other

Identifiers

NCT04080193

DRKS00016623 (Registry Identifier)

71/02060305

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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).

Treatment:

Behavioral: Smartphone-based interventional trial

Control Group

No Intervention group

Description:

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