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Baltimore, Maryland 21205


Purpose:

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.


Study summary:

- Interested persons, recruited by advertisement and screened by telephone (Appendix B), will report to the Johns Hopkins Bloomberg School of Public Health for in-person screening. At the screening session, we will obtain informed consent, HIPAA consent, medical-history information (including current medications, alcohol, and cigarette use), and baseline measurements of bioelectrical impedance (BIA—body composition testing), blood pressure, pulse, body weight, and waist and hip circumference. Individuals will also be screened with established instruments for eating-disorder symptoms (Appendix C), and depression (Appendix D). - After deemed eligible, subjects will be prescribed an individualized diet and exercise program at Visit 2 (Week 0). Additional questionnaires to be done at this visit: Restraint Scale, Three-Factor Eating Questionnaire (TFEQ), and Reasons for Dieting (Appendix E). - At the same visit, each participant will be issued a PDA and trained in its use as an Electronic Diary (ED). Participants will be expected to carry their PDAs at all times. - A 4-week period of high-frequency monitoring will begin immediately: random prompts to initiate recordings will occur 0-5 times per day for 4 weeks. Participants must respond to at least 85% of all random prompts within 15 minutes. Participants will also initiate recordings whenever they have just experienced an urge to eat, or whenever they have actually eaten. - Participants will be randomly assigned to a Group condition or a No-Group condition. - In the Group condition, participants will attend 10 group meetings, starting at Week 2 (Visit 4), to strengthen diet-adherence and lapse-management skills. Group meetings will be held once every week for the first 5 weeks, and once every other week for the next 11 weeks. - In the No-group condition, participants will be given some written tips on diet adherence, but will not attend group. - All participants must come to the clinic at scheduled times (one time per week) to upload information from the PDA to a central data source. Participants will also be weighed at these visits. This may, for some participants, coincide with the scheduled group meetings - During Week 5-16, the frequency of EMA random prompts will be reduced to 0-2 per day. - During Week 8 we will re-weigh the participant and reevaluate each participant’s diet and exercise program to ensure a proper and safe weight-maintenance regimen. We will also record the participant’s height, weight, BIA, waist and hip measurements, blood pressure, and pulse. - A final reevaluation and weigh-in will also occur when the participant finishes the study (Week 17). We will also record the participant’s height, weight, BIA, waist and hip measurements, blood pressure, and pulse - Participants will return their PDA to the clinic at this visit. - At Weeks 26 and 52, participants will return for a follow-up visits at which they will be re-weighed and their current diet and exercise habits will be assessed. We will also record their height, weight, BIA, waist and hip measurements, blood pressure, and pulse. - Participants will be paid $15 each time they provide ED data for upload (up to a maximum once per week). Subjects will receive an additional $80 for completing all 16 weeks, for a possible total of $320. Additionally, participants will be paid $50 for each follow-up visit at Weeks 26 and 52. Total compensation will be $420 for completion of the entire protocol. In addition, participants will be provided compensation for paying to park at a garage at the Johns Hopkins campus. - Participants will be removed from the study if they: behave inappropriately; lose or damage two PDAs; miss more than three scheduled clinic visits; or fail to respond within 15 minutes to more than 15% of random prompts during either phase 1 or 2 of EMA.


Criteria:

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.


NCT ID:

NCT00198783


Primary Contact:

Principal Investigator
Lawrence J Cheskin, MD
Johns Hopkins Bloomberg School of Public Health


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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