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Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health National Institute on Drug Abuse (NIDA) |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00198783 |
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.
Condition |
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Obesity Weight Maintenance |
Study Type: | Observational |
Study Design: | Longitudinal, Defined Population, Prospective Study |
Official Title: | Real-Time Assessment of Food Craving, Use, and Triggers During Outpatient Treatment of Obesity: A Development and Feasibility Study |
Estimated Enrollment: | 75 |
Study Start Date: | August 2005 |
Study Completion Date: | January 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
United States, Maryland | |
Johns Hopkins Bloomberg School of Public Health | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Lawrence J Cheskin, MD | Johns Hopkins Bloomberg School of Public Health |
Study ID Numbers: | NIDA2005-01 |
Study First Received: | September 12, 2005 |
Last Updated: | April 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00198783 |
Health Authority: | United States: Institutional Review Board |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |