Multidisciplinary treatment program for overweight in a primary care setting

ISRCTN	ISRCTN61786515
DOI	https://doi.org/10.1186/ISRCTN61786515
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr E.A. Molenaar
Scientific

University Medical Center Utrecht (UMCU)
Julius Center for Health Sciences and Primary Care
Str. 6.131
P.O. Box 85000
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 2538644
Email	e.a.molenaar@umcutrecht.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Multidisciplinary treatment program for overweight in a primary care setting
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	09/03/2006
Completion date	30/06/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	150
Total final enrolment	134
Key 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
Key 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
Date of first enrolment	09/03/2006
Date of final enrolment	30/06/2007

University Medical Center Utrecht (UMCU)

Utrecht
3508 GA
Netherlands

University Medical Center Utrecht (UMCU) (The Netherlands)
University/education

P.O. Box 85500
Utrecht
3508 GA
Netherlands

"ROR"	https://ror.org/0575yy874

Government

Dutch Ministry of Health, Welfare and Sport
Government organisation / National government

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010	02/05/2019	Yes	No

02/05/2019: Publication reference and total final enrolment added.