|- candidate number||23304|
|- NTR Number||NTR5473|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-okt-2015|
|- Secondary IDs||159_09_06_2015_A1 //12028 Ethische Commissie Psychologie (ECP) te Maastricht // Healthy Lifestyle Solutions (HLS)|
|- Public Title||Effectiveness of cCBT-Based Ecological Momentary Intervention vs. Diet-Only for Obesity |
|- Scientific Title||Effectiveness of cCBT-Based Ecological Momentary Intervention vs. Diet-Only for Obesity |
|- ACRONYM||Think Slim|
|- hypothesis||Relative to a diet-only wait-list control condition, cCBT-Based Ecological Momentary Intervention is more effective at...
(1) ...achieving (sustained) weight loss, also at a 3-month and 1-year follow-up.
(2) ...reducing eating-related dysfunctional cognitions.
(3) ...establishing healthier eating patterns.
|- Healt Condition(s) or Problem(s) studied||Obesity|
|- Inclusion criteria||(1) Age: between 18 and 60|
(2) BMI > 25
(3) Fluent in Dutch
(4) In possession of an iPhone
|- Exclusion criteria||(1) Pregnancy|
(2) Eating disorders
(3) Appetite-influencing medication
(4) Treatment for depression
(5) Cardiovascular disease
(6) Enrolment in other obesity-related treatments (under supervision by a healthcare professional)
(8) Going on extended holidays (>7 days) during the trial period.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-jan-2016|
|- planned closingdate||2-mei-2016|
|- Target number of participants||102|
|- Interventions||(1) Computerized Cognitive Behavioural Therapy (cCBT) for Obesity provided as an Ecological Momentary Intervention (EMI), with no therapist involvement + Calorie-restricting diet|
(2) Calorie-restricting diet only
|- Primary outcome||(1) Weight loss immediately after the intervention|
(2) Weight loss at respectively 3-months and 1-year post-intervention
|- Secondary outcome||(1) Influence of eating-related dysfunctional cognitions|
(2) Patterns of behaviour leading to healthy/unhealthy eating
|- Timepoints||6 Weeks of cCBT preceded and followed by 1 week of Ecological Momentary Assessment|
|- Trial web site||www.thinkslim.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. Bastiaan Boh|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Bastiaan Boh|
|- Sponsor/Initiator ||Maastricht University|
(Source(s) of Monetary or Material Support)
|Philips, Stichting Technologische Wetenschappen (STW), NWO, Nationaal Initiatief Hersenen & Cognitie (NIHC)|
|- Brief summary||Importantly, it should be noted that ethical approval was obtained from the standing ethical committee of the Faculty of Psychology and Neuroscience (FPN) of Maastricht University. The METC of the Maastricht Academic hospital and FPN have an agreement on which research proposals can be evaluated by the faculty ethical committee and which ones have to be forwarded to the METC.
This trial will investigate the effectiveness of a momentary assessment-based intervention (Think Slim) that includes a cCBT for obesity protocol delivered via the internet and smartphone. Of particular interest is the effectiveness of Think Slim to reduce post-intervention weight regain.
|- Main changes (audit trail)|
|- RECORD||26-okt-2015 - 23-dec-2015|