Multidisciplinary treatment program for overweight in a primary care setting
| ISRCTN | ISRCTN61786515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61786515 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | N/A |
| Sponsor | University Medical Center Utrecht (UMCU) (The Netherlands) |
| Funder | Dutch Ministry of Health, Welfare and Sport |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 02/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E.A. Molenaar
Scientific
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 |
|---|---|
| e.a.molenaar@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) | Change in weight. |
| Key secondary outcome measure(s) | 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 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | 02/05/2019 | Yes | No |
Editorial Notes
02/05/2019: Publication reference and total final enrolment added.
