Weight Loss Prior Mamma Reduction - A Pilot Study

Not Applicable

Completed

• Conditions: Weight Loss; Hypertrophy
• Interventions: Dietary Supplement: Low energy diet

• Registration Number: NCT02659371
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-01
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-20
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low energy diet	Low energy diet	Low energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d.

Primary Outcome Measures

Name	Time	Method
Weight loss	12 weeks	Measurement of weight to nearest 0.1 kg on category III approved body weight

Secondary Outcome Measures

Name	Time	Method
Pain and discomfort	12 weeks	Questionnaire on pain in head, neck, shoulders
Breast size	12 weeks	anthropometric measurements of the breasts by measuring tape.
Breast volumen	12 weeks	measure of breast volumen

Trial Locations

Locations (1)

Copenhagen University Hospital at Herlev (EFFECT); 🇩🇰 Herlev, Denmark