Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.M.M. Eijsvogel

ORCID ID

Contact details

Medisch Spectrum Twente
Department of Pulmonology
P.O. Box 50000
Enschede
7500 KA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR353; MEC: P03-27

Study information

Scientific title

Acronym

BANdeBuik

Study hypothesis

The use of a Body Area Network (BAN) in a weight reduction program has a positive effect, due to a higher compliance, on weight loss, total body fat and body fat distribution.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Obesity, Sleep apnoea

Intervention

Intervention group: a weight reduction program, that consists of a training schedule and a diet, and feedback on the compliance of the training schedule measured by a Body Area Network (BAN).
Control group: a weight reduction program, that consists of a training schedule and a diet.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Weight loss, measured by body weight every month.

Secondary outcome measures

1. Fat free mass, measured by an bio-electrical impedance analysis
2. Total body fat, measured by an bio-electrical impedance analysis
3. Body fat distribution, measured by the waist-to-hip ratio
4. Utility of the BAN, measured by an semi-structured in-depth interview

Overall trial start date

30/03/2003

Overall trial end date

08/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Body Mass Index between 30 - 40 kg/m^2
2. A ratio of waist circumference to hip circumference greater than 1.0
3. Age range between 18 and 60 years old
4. A normal glucose tolerance and plasma lipid profile
5. A stable weight (± 2kg) for 6 months before study entry
6. A minimum of 6 months without any weight reduction programs

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20

Participant exclusion criteria

Patients will be excluded if:
1. They smoke
2. They consume more than two alcoholic drinks per day
3. They suffer from claudicate intermittent or angina pectoris
4. They have osteoarthritis of the lower extremity
5. They have active cancer, type 1 diabetes or type 2 diabetes
6. They have undergone any surgery to lose weight
7. Dietary fat reduction or exercise was contraindicated for medical reasons
8. They use medications known to affect weight gain or loss
9. They have a diagnosis of bulimia

Recruitment start date

30/03/2003

Recruitment end date

08/09/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Medisch Spectrum Twente
Enschede
7500 KA
Netherlands

Sponsor information

Organisation

Medisch Spectrum Twente (Netherlands)

Sponsor details

P.O. Box 50000
Enschede
7500 KA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.mstwente.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Medisch Spectrum Twente (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes