NCT02659371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

November 9, 2015

Last Update Submit

August 3, 2016

Conditions

Weight LossHypertrophy

Outcome Measures

Primary Outcomes (1)

  • Weight loss

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

    12 weeks

Secondary Outcomes (3)

  • Breast volumen

    12 weeks

  • Breast size

    12 weeks

  • Pain and discomfort

    12 weeks

Other Outcomes (3)

  • Blood bio markers

    12 weeks

  • Hip circumference

    12 weeks

  • Waist circumference

    12 weeks

Study Arms (1)

Low energy diet

EXPERIMENTAL

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

Dietary Supplement: Low energy diet

Interventions

Low energy dietDIETARY_SUPPLEMENT
Low energy diet

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • entitled to mammoplasty,
  • motivated towards participation in a weight loss program
  • BMI within the range 25.5 to 35 kg/m2

You may not qualify if:

  • more than 65 years of age
  • insulin-dependent diabetes
  • chronic heart, liver or kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital at Herlev (EFFECT)

Herlev, Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Weight LossHypertrophy

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Arne Astrup, MDDrMedSci

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research

Study Record Dates

First Submitted

November 9, 2015

First Posted

January 20, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2015

Study Completion

May 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

DK(1)