real-time assessment of food craving, use, and triggers during outpatient treatment of obesity: a development and feasibility study

Conditions: Obesity; Weight Maintenance

Summary: 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.

* 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.

Eligibility 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.