Obesity Clinical Trial
Official title:
Real-Time Assessment of Food Craving, Use, and Triggers During Outpatient Treatment of Obesity: A Development and Feasibility Study
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.
;
Observational Model: Defined Population, Time Perspective: Longitudinal
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