Finding studies
Finding studies
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Lead
University of Pittsburgh
With
Participants (N=150) with overweight/obesity (body mass index ≥25.0 kg/m\^2) will be recruited locally via media outlets, flier postings, and local research registries to participate in a novel laboratory-based intervention to attenuate craving for and intake of high calorie foods. Interested individuals will be screened over the phone to determine eligibility to participate. Once participants are deemed eligible, they will be scheduled for their sessions. All participants will attend seven sessions, the first four of which occur on four consecutive days: a baseline cue-reactivity session, two consecutive days of either retrieval extinction (R-E) training or extinction control, and four follow-up food cue-reactivity sessions taking place 24-hr, 2-weeks, 1-month, and 3-months after the second R-E/extinction training control session. Participants in the latter half of study recruitment will also participate in ecological momentary assessment (EMA) to collect data on real-world food cues, craving, and food intake. Those participants will engage in one pre-baseline session to receive instructions and a tutorial on a run-in period of baseline EMA data collection prior to the baseline session. Participants will be food-deprived for three hr prior to all sessions to standardize hunger. Participants will also be asked to avoid consuming high calorie foods/drinks from the night before the baseline session through the end of the day of the 24-hr follow-up session to avoid reinforcing high calorie food intake before or after extinction. BASELINE SESSION: At the 2.5-hr baseline session, participants will first provide written Institutional Review Board (IRB)-approved informed consent. Participants will then be interviewed to report recent food/drink intake as well as various health-related behaviors (nicotine, alcohol, caffeine, cannabis, and other substance use, medication use, sleep, physical activity). Next, after a 10-min acclimation period, participants will complete baseline assessments of hunger and craving, including self-report state food craving, skin conductance, heart rate, and salivation. To assess heart rate, electrodes will be placed beneath the ribcage and the clavicle.Two silver/silver chloride (Ag/AgCl) electrodes will be affixed to the palm of the non-dominant hand to assess skin conductance. Heart rate and skin conductance will be assessed and scored using MindWare Technologies hardware and MindWare Technologies/BioLab software. The Strongin-Hinsie Peck procedure will be used to assess saliva production. Three pre-weighed cotton dental rolls, one placed beneath the tongue and two placed buccally for two min, will be removed and placed in plastic bags for weighing to assess the amount of saliva secreted. Participants will then complete a food cue-reactivity task using E-Prime software and a bogus taste test (see "TASK DESCRIPTION" section below). At the end of the session, participants will complete measures of demographics (e.g., age, sex, race), socioeconomic status, motivation to lose weight, trait food craving, dietary restraint and disinhibited eating, impulsivity, negative and positive affect, depressive symptoms, social support, food insecurity, sleep, physical activity, disordered eating symptoms, eating behaviors, reward-based eating drive, weight and diet history, and a health questionnaire. Participants will also complete a food frequency questionnaire to assess food/drink intake over the past week. Height will be assessed via a calibrated stadiometer and weight will be assessed by calibrated digital scale in street clothes and without shoes. Participants will be reminded to abstain from consuming high calorie foods/drinks through the end of the day of the 24-hr follow-up session. After the baseline session, participants will be randomized to either a high calorie food retrieval + high calorie food extinction (R-E training) group or to a non-food retrieval + high calorie food extinction (extinction control) group at the next two sessions. R-E/EXTINCTION TRAINING SESSIONS: Participants will return to the lab on the next two consecutive days after the baseline session to engage in food-related retrieval + 60-min extinction training for high calorie foods (R-E training group) or non-food-related retrieval + 60-min extinction training for high calorie foods (extinction control group). These two sessions will last approximately 2.5-hr each and will be identical in their procedures. Similar to the baseline session, participants will first be interviewed to report past 24-hr food/drink intake and past 24-hr health-related behaviors including nicotine, alcohol, caffeine, cannabis, and other substance use, medication use, sleep, and physical activity. After the 10-min acclimation period, participants will complete baseline assessments of hunger and craving (self-report, heart rate, skin conductance, salivation). During the R-E and extinction control training, participants will first observe retrieval cues: either the same sequence of high calorie food cues observed at the baseline session (R-E training group) or a sequence of non-food-related cues (extinction control group). After 10-min of rest following retrieval, all participants will engage in 60-min of high calorie food extinction training (see complete details in the "TASK DESCRIPTION" section below). Measures of heart rate, skin conductance, and salivation will be collected throughout extinction training. Finally, participants will repeat assessments of negative and positive affect and will be weighed. FOLLOW-UP SESSIONS: Follow-up sessions will occur 24-hr, 2-week, and 1- and 3-month after the second R-E/extinction training session and will last approximately two hr each. Sessions will begin with an interview to assess recent food and drink intake and past 24-hr health behaviors. After 10-min of acclimation, participants will complete baseline craving, hunger, and psychophysiological (heart rate, skin conductance, salivation) measures, a food cue-reactivity task, and weight measurement. Similar to prior sessions, heart rate, skin conductance, and salivation will be collected throughout the food cue-reactivity task. Participants will also repeat assessments of motivation to lose weight, state food craving, dietary restraint and disinhibited eating, impulsivity, negative and positive affect, physical activity, eating behavior, and reward-based eating drive at follow-up sessions. Participants will complete a past-week food frequency questionnaire at the 2-week, 1-month, and 3-month follow-up sessions as well as the bogus taste test at 1- and 3-month follow-up (identical to the baseline session). Participants will be weighed at the end of every session. EMA: Half of the participants involved in this clinical trial (n=75; starting in Year 3 of the funding period) will engage in EMA to collect data on naturally-occurring food cues, eating context (e.g., presence of others, eating context), food craving, hunger, negative and positive affect, and food intake via EMA. Data will be collected through a web-based app developed through the Office of Academic Computing at the University of Pittsburgh. Data collection will occur in three measurement bursts over three consecutive days (a) \~4-6 days before baseline, and between (b) 24-hr and 2-week, and (c) 2-week and 1-month follow-up. Participants will be asked to respond to (a) 'random,' (b) 'time-contingent,' and (c) 'event-contingent' prompts. Random assessments will occur at random times over the 3-day measurement bursts and time-contingent assessments will occur at fixed times each day, including beginning and end of day prompts sent at participant-preferred times. On average, participants will be prompted five times daily on each of the three EMA days. Participants will be instructed to initiate event-contingent assessments when a predefined event occurs, including eating or craving food. To encourage compliance, participants will be compensated per EMA entry and a daily bonus when all prompted entries are completed. TASK DESCRIPTION FOOD CUE-REACTIVITY TASK: The food cue-reactivity task is a computerized task programmed using E-Prime software. At the baseline session, participants will observe 30 high calorie pictorial food cues on the computer in a 5-min cue sequence. At each follow-up session participants will observe the same 5-min high calorie food cue sequence observed at the baseline session plus an additional novel 5-min high calorie food cue sequence to assess the generalizability of R-E/extinction control training to novel food cues. During a 5-min cue sequence, participants will observe a pictorial food cue on the computer screen for 8-s each, with a 2-s delay between pictorial cues, resulting in 5-min of high calorie pictorial food cue presentation at baseline and 10-min at each follow-up session. Self-report craving will be assessed after the first 2-min of cue presentation and again at the end of the cue sequence. The first self-report craving assessment will occur at 2-min into the cue sequence to coincide with the salivation measure that will occur across the same 2-min (the Strongin-Hinsie Peck procedure). Heart rate and skin conductance will be assessed continuously throughout 5-min cue sequences. R-E/EXTINCTION TRAINING CONTROL: On both training days, participants will observe retrieval cues: either the same 5-min sequence of high calorie pictorial food cues observed during the food cue-reactivity task at the baseline session (R-E training group) or 5-min of non-food-related cues (extinction control group). After 10-min of rest following retrieval, all participants will engage in 60-min of high calorie food extinction training. Extinction training will involve 12, 5-min high calorie food cue sequences: 6 pictorial and 6 real food cue sequences. Pictorial food cue sequences will involve timing that is identical to pictorial food cue sequences at the other sessions: participants will observe a pictorial food cue on the computer screen for 8-s each, with a 2-s delay between pictorial cues. Real food cues will be individualized for each participant, reflecting foods with the highest palatability ratings provided during phone screening. During 5-min real food cue sequences, participants will be instructed to remove the food from its bowl and to observe, handle, smell, bring the food to their lips, and imagine eating the food. Self-reported craving will be assessed at the same time points as during the 5-min cue sequences of food cue-reactivity tasks at other sessions: 2-min into cue sequences and again at the end of 5-min cue sequences. Salivation will not be assessed during the 60-min of extinction training to reduce participant burden and ensure that extinction training has its intended effects (i.e., to avoid interference of collecting numerous saliva measures on the effectiveness of extinction training). Heart rate and skin conductance will be measured continuously throughout the 60-min of extinction training. BOGUS TASTE TEST: The validated bogus taste test will be used to assess in-lab food intake at the baseline session and the 1- and 3-month follow-up sessions. During the bogus taste test, participants will be provided four, 12-ounce bowls filled with the four high calorie foods with the highest palatability ratings provided during phone screening. Participants will be instructed to take at least one bite of each food and answer taste perception questions about those foods. Participants will be instructed that they have 10-min to complete this task and can eat leftover foods in any remaining time. Unknown to participants, food bowls will be weighed pre- and post-task to assess the amount of food consumed. Food consumed (g) will be converted into energy intake (calories) for analysis.
Age
18–59
Sex
ALL
Healthy volunteers
Not accepted
