Real-Time Assessment of Food Craving, Use, and Triggers During Outpatient Treatment of Obesity: A Development and Feasibility Study
3 aprile 2007 aggiornato da: Johns Hopkins Bloomberg School of Public Health
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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
- 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.
Tipo di studio
Osservativo
Iscrizione
75
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21205
- Johns Hopkins Bloomberg School of Public Health
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Lawrence J Cheskin, MD, Johns Hopkins Bloomberg School of Public Health
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2005
Completamento dello studio (Effettivo)
1 gennaio 2007
Date di iscrizione allo studio
Primo inviato
12 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
12 settembre 2005
Primo Inserito (Stima)
20 settembre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
4 aprile 2007
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 aprile 2007
Ultimo verificato
1 aprile 2007
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NIDA2005-01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .