Effect of a Body Area Network (BAN) as an additional factor in a weight reduction program by patients with obesity: BANdeBuik

ISRCTN	ISRCTN25733807
DOI	https://doi.org/10.1186/ISRCTN25733807
Protocol serial number	NTR353; MEC: P03-27
Sponsor	Medisch Spectrum Twente (Netherlands)
Funder	Medisch Spectrum Twente (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr M.M.M. Eijsvogel
Scientific

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

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BANdeBuik
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Weight loss, measured by body weight every month.
Key secondary outcome measure(s)	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
Completion date	08/09/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	30/03/2003
Date of final enrolment	08/09/2005

Medisch Spectrum Twente

Enschede
7500 KA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan