Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
28/04/2006
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 E.A. Molenaar

ORCID ID

Contact details

University Medical Center Utrecht (UMCU)
Julius Center for Health Sciences and Primary Care
Str. 6.131
P.O. Box 85000
Utrecht
3508 GA
Netherlands
+31 (0)30 2538644
e.a.molenaar@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Treatment of overweight by a dietician has a larger effect on weight loss and risk profile as compared to no treatment. Additional treatment by a physiotherapist is beneficial for long-term maintenance of the result achieved as compared to treatment by a dietician only.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Overweight

Intervention

1. Monthly meetings with a dietician during a half year period
2. Monthly meetings with both a dietician and a physiotherapist during a half year period
3. Routine health care (control)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in weight.

Secondary outcome measures

Effect evaluation:
1. Change in BMI and waist circumference
2. Change in blood pressure, blood glucose, blood lipids and Framingham risk score
3. Change in energy intake and energy consumption
4. Change in physical condition
5. Change in use of health care and medication use

Process evaluation:
6. Response
7. Compliance
8. Program-associated costs and workload

Overall trial start date

09/03/2006

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. >/= 18 and <65 years of age
2. Body mass index (BMI) >/= 28 and <35 kg/m^2
3. Knowledge of the Dutch language
4. Participate in the Utrecht Health Project, a community-based prospective cohort study in Leidsche Rijn, part of the city of Utrecht, The Netherlands

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Participate in any other former or current intervention related to overweight
2. Already under treatment by a dietician or physiotherapist
3. Known diagnosis of depression, schizophrenia, anxiety disorder, binge eating disorder or bulimia nervosa
4. Pregnancy
5. Moving plans

Recruitment start date

09/03/2006

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Dutch Ministry of Health, Welfare and Sport

Alternative name(s)

Dutch Ministry of Health, Welfare and Sport, VWS

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Netherlands

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