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van CCT (UK)

van CCT (UK)


- candidate number0
- NTR NumberNTR353
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR22-jul-2005
- Secondary IDsMEC: P03-27 
- Public TitleBANdeBuik.
- Scientific TitleEffect of a Body Area Network (BAN) as an additional factor in a weight reduction program by patients with obesitas:
- hypothesisThe 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 en body fat distribution.
- Healt Condition(s) or Problem(s) studiedObesity, Sleep apnea
- Inclusion criteria1. Body Mass Index between 30 40 kg/m2;
2. A ratio of waist circumference to hip circumference >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 month before study entry;
6. A minimum of 6 months without any weight reduction programs.
- Exclusion criteriaPatients 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-mrt-2003
- planned closingdate8-sep-2005
- Target number of participants20
- InterventionsIntervention 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.
- Primary outcomeWeight loss, measured by body weight every month.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente, Enschede
- PublicationsN/A
- Brief summaryA pilot study to investigate whether the use of a BAN increases the compliance of obesitas patients with the weight reduction program and the effect on weight loss, total body fat, fat free mass and body fat distribution. Furthermore, we want to investigate the utility of a BAN for the patients, doctors and other health personnel. The weight reduction program will last for 3 months. After this program patients will be followed for 6 months. The study will contain a total of 20 patients with obesitas. The patients are randomly assigned to either the intervention or control group. Patients from the control group will receive a low-fat, high-carbohydrate diet, which is developed by a dietician. The patients are all free-living and consume self-selected foods. Beyond that, patients receive a training schedule. This schedule consists of 15 minutes brisk walking the first days and will be increased to finally 45 minutes of brisk walking every day. Patients will be contacted weekly by telephone about the feasibility of the training schedule.
Patients randomised to the intervention group receive the same care as the control group, but they receive additionally a BAN. A BAN is an easy to wear, health-monitoring system. The BAN can measure the activity of the patients. Therefore, during the telephone contact, patients will not only be contacted about the feasibility of the training schedule but also on their physical activity during the last week.
- Main changes (audit trail)
- RECORD19-okt-2005 - 11-sep-2008

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