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De Coaching op Leefstijl (CooL) Interventie voor Obesitas


- candidate number26480
- NTR NumberNTR6208
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2017
- Secondary IDs201400052 CZ 
- Public TitleDe Coaching op Leefstijl (CooL) Interventie voor Obesitas
- Scientific TitleThe Coaching on Lifestyle (CooL) Intervention for Obesity
- ACRONYMCooL
- hypothesisHypotheses are that the long-term supervision of the CooL intervention will be related to beneficial changes in the participants¡¯ energy-balance related behaviours, body composition, and quality of life. Besides, the goal of the intervention is to structurally embed lifestyle coaching in the health care process.
- Healt Condition(s) or Problem(s) studiedOverweight, Obesity, Children, Adults
- Inclusion criteriaIn this intervention, the lifestyle coach coaches individuals from 4 years and older with (a high risk of) obesity. These are persons with either obesity (BMI ¡İ 30) or overweight (BMI ¡İ 25) with a (moderately) increased risk of cardiovascular diseases or diabetes mellitus type II, according to the National Integrated Health Care Standard Obesity. For children and adolescents (under 18 years) a BMI cut-off point per age has been set in this Care Standard Obesity. Also, the participants must have a health insurance policy at the Dutch health insurance companies CZ or VGZ or one of their subsidiaries.
- Exclusion criteriaA lack of motivation to participate into the intervention or having medical problem(s).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate31-mrt-2017
- Target number of participants470
- InterventionsThe Coaching on Lifestyle (CooL) intervention is a new Dutch CLI, in which the lifestyle coach coaches participants with (a high risk of) obesity. In group and individual sessions the lifestyle coach addresses themes such as sleep, stress, physical activity, and dietary behaviours.
In the adult basic program, participants are coached for 6 to 8 months (see Table 2 for an overview of the sessions). The groups consist of 4 to 12 participants. Adults receive 8 group sessions (of 90 minutes) and 4 individual sessions (of 30 minutes). The child program consists of 8 group sessions with parents, 4 individual sessions at home with the family, and around 6 telephone sessions with the child. The focus is to provide the parents tips for positive parenting styles and for changing their child¡¯s lifestyle into a healthier one. The adolescent program is a combination of the children and adults program, with a greater emphasis on social influences of, for example, peers.
- Primary outcomeChildren: objectively measured BMI and self-reported quality of life.

Adults: objectively measured BMI, self-reported quality of life, and biomedical data (Hb1AC, blood pressure, and fasting glucose).
- Secondary outcomeChildren: the quality of motivation for physical activity and for diet, physical activity level, dietary behaviours, sleeping behaviour, personality, cognitive determinants, general parenting, parenting styles, and process measures (number of participants and drop-out).

Adults: the quality of motivation for physical activity and for diet, physical activity level, dietary behaviours, personality, cognitive determinants, and process measures (number of participants and drop-out).
- TimepointsBaseline:
Children: objectively measured BMI and self-reported quality of life, the quality of motivation for physical activity and for diet, physical activity level, dietary behaviours, sleeping behaviour, personality, cognitive determinants, general parenting, and parenting styles.

Adults: objectively measured BMI, self-reported quality of life, and biomedical data (Hb1AC, blood pressure, and fasting glucose), the quality of motivation for physical activity and for diet, physical activity level, dietary behaviours, personality, and cognitive determinants.

32 to 44 weeks follow-up:
Children: objectively measured BMI and self-reported quality of life, the quality of motivation for physical activity and for diet, physical activity level, dietary behaviours, sleeping behaviour, personality, cognitive determinants, and process measures (number of participants and drop-out).

Adults: objectively measured BMI, self-reported quality of life, biomedical data (Hb1AC, blood pressure, and fasting glucose), the quality of motivation for physical activity and for diet, physical activity level, dietary behaviours, personality, cognitive determinants, and process measures (number of participants and drop-out).

18 months follow-up:
Children: objectively measured BMI and self-reported quality of life, the quality of motivation for physical activity and for diet, physical activity level, dietary behaviours, sleeping behaviour, personality, cognitive determinants, general parenting, and parenting styles.

Adults: self-reported quality of life, the quality of motivation for physical activity and for diet, physical activity level, dietary behaviours, personality, and cognitive determinants.
- Trial web siteNot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Celeste van Rinsum
- CONTACT for SCIENTIFIC QUERIES Stef Kremers
- Sponsor/Initiator CZ, health insurance company
- Funding
(Source(s) of Monetary or Material Support)
CZ zorgverzekeringen
- PublicationsNot applicable
- Brief summaryThe Coaching on Lifestyle (CooL) intervention is a new Dutch CLI, in which the lifestyle coach coaches participants with (a high risk of) obesity. In group and individual sessions the lifestyle coach addresses themes such as sleep, stress, physical activity, and dietary behaviours. The goal of the intervention is to structurally embed lifestyle coaching in the health care process and to promote sustained lifestyle changes in the participants related to physical activity and diet.
- Main changes (audit trail)
- RECORD13-jan-2017 - 5-mrt-2017


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