Obesity Clinical Trial
Official title:
Real-Time Assessment of Food Craving, Use, and Triggers During Outpatient Treatment of Obesity: A Development and Feasibility Study
The objective of this study will assess the feasibility of utilizing real-time data monitoring in future clinical trials of weight control medications and other treatment modalities, along with the feasibility of distinguishing different types of relapses over 16 weeks: There will be 4 weeks of high-intensity EMA and 12 weeks of low-intensity EMA. Each participant will be in the study for 52 weeks with 20 visits, including follow-up visits.
Status | Completed |
Enrollment | 75 |
Est. completion date | January 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1) age between 18 and 65; 2) BMI > 30 kg/m2 prior to weight loss; 3) initial weight loss in the 12-month period prior to enrolling of at least 10% of starting body weight; 4) no more than 50% regain of that initial weight loss by the time of screening. Exclusion Criteria: 1) Schizophrenia or any other DSM-IV psychotic disorder; history of bipolar disorder; current Major Depressive Disorder; 2) current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-IV criteria); 3) cognitive impairment severe enough to preclude informed consent or valid self-report; 4) medical illness that in the view of the investigators would compromise participation in research. |
Observational Model: Defined Population, Time Perspective: Longitudinal
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | National Institute on Drug Abuse (NIDA) |
United States,
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