Weight Loss Prior Mamma Reduction - A Pilot Study

Copenhagen University Hospital at Herlev6 enrolled

Overview

Due to a higher risk of complications, obese and overweight patients with macromastia are in Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI \< 25 kg/m2. The study is a pilot study with a diet intervention group and no control group. The intervention is a 12 week low energy diet pre-operative weight loss program investigating if this will result in weight loss making the overweight and obese patients eligible for breast reduction surgery i.e. BMI \< 25.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Weight Loss Hypertrophy

Interventions

Low energy dietDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * entitled to mammoplasty, * motivated towards participation in a weight loss program * BMI within the range 25.5 to 35 kg/m2 Exclusion Criteria: * more than 65 years of age * insulin-dependent diabetes * chronic heart, liver or kidney failure

Locations (1)

Copenhagen University Hospital at Herlev (EFFECT)

Herlev, Herlev, Denmark

Outcomes

Primary Outcomes

Weight loss

Measurement of weight to nearest 0.1 kg on category III approved body weight

Time frame: 12 weeks

Secondary Outcomes

Breast volumen

measure of breast volumen

Time frame: 12 weeks

Breast size

anthropometric measurements of the breasts by measuring tape.

Time frame: 12 weeks

Pain and discomfort

Questionnaire on pain in head, neck, shoulders

Time frame: 12 weeks

Data from ClinicalTrials.gov

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