Real-Time Assessment of Food Craving, Use, and Triggers During Outpatient Treatment of Obesity: A Development and Feasibility Study
Condition: Obesity; Weight Maintenance
MeSH terms: Obesity
Study type: Observational

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.
    

Detailed description: 
      -  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.
    

Observational model: Defined Population
Time perspective: Prospective