|- candidate number||2020|
|- NTR Number||NTR630|
|- Date ISRCTN created||28-apr-2006|
|- date ISRCTN requested||25-apr-2006|
|- Date Registered NTR||16-mrt-2006|
|- Secondary IDs||N/A |
|- Public Title||Multidisciplinary treatment program for overweight in a primary care setting.|
|- Scientific Title||Multidisciplinary treatment program for overweight in a primary care setting.|
|- 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. |
|- Healt Condition(s) or Problem(s) studied||Overweight|
|- Inclusion criteria||1. >= 18 and < 65 years of age;|
2. Body Mass Index >= 28 and < 35 kg/m2;
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.
|- 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;
5. Moving plans.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||9-mrt-2006|
|- planned closingdate||30-jun-2007|
|- Target number of participants||150|
|- Interventions||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).
|- Primary outcome||Change in weight.|
|- Secondary outcome||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 energyconsumption;
4. Change in physical condition;
5. Change in use of health care and medication use.
8. Program-associated costs and workload.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. E.A. Molenaar|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. M.E. Numans|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Dutch Ministry of Health, Welfare and Sport|
|- Brief summary||Overweight is increasing and associated with various health problems. In spite of the high prevalence, there are no well-structured primary care programs for overweight available in The Netherlands. Therefore, we developed a six-month multidisciplinary treatment program in a primary care setting that will be evaluated by using the research infrastructure of the Utrecht Health Project, a community-based prospective cohort study.
The aim of the present study is to determine the feasibility and efficacy of a multidisciplinary treatment program on weight loss and risk profile in an adult overweight population.
Hundred participants of the Utrecht Health Project are randomised to either a dietetic group or a dietetic plus physiotherapy group. The control group consist of another fifty participants recruited from the Utrecht Health Project and receives routine health care. Outcome measures are assessed at baseline, at the end of the treatment program and six months after the end of the treatment program.
The treatment program is considered effective with at least a 5% difference in mean weight change over time between the control and intervention groups.
Positive evaluation of the multidisciplinary treatment program for overweight may lead to implementation in routine primary health care. |
|- Main changes (audit trail)|
|- RECORD||16-mrt-2006 - 1-dec-2009|