Design of the PACIFIC study: A randomized controlled trial evaluating a novel treatment for adults with overweight and obesity

Diabetes Prevention Program (DPP) Research Group, 2002, The Diabetes Prevention Program (DPP): description of lifestyle intervention, Diabetes Care, 25, 2165, 10.2337/diacare.25.12.2165 Look AHEAD Research Group, 2007, Reduction in weight and cardiovascular disease risk factors in individuals with Type 2 diabetes: one-year results of the look AHEAD trial, Diabetes Care, 30, 1374, 10.2337/dc07-0048 Wadden, 2007, Lifestyle modification for the management of obesity, Gastroenterology., 132, 2226, 10.1053/j.gastro.2007.03.051 Wadden, 2009, One-year weight losses in the look AHEAD study: factors associated with success, Obesity (Silver Spring), 17, 713, 10.1038/oby.2008.637 Wing, 2004, Achieving weight and activity goals among diabetes prevention program lifestyle participants, Obes. Res., 12, 1426, 10.1038/oby.2004.179 Dombrowski, 2014, Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials, BMJ., 348, g2646, 10.1136/bmj.g2646 Carnell, 2013, Appetitive traits from infancy to adolescence: using behavioral and neural measures to investigate obesity risk, Physiol. Behav., 121, 79, 10.1016/j.physbeh.2013.02.015 Llewellyn, 2015, Behavioral susceptibility to obesity: gene-environment interplay in the development of weight, Physiol. Behav., 152, 494, 10.1016/j.physbeh.2015.07.006 Carnell, 2008, Appetite and adiposity in children: evidence for a behavioral susceptibility theory of obesity, Am. J. Clin. Nutr., 88, 22, 10.1093/ajcn/88.1.22 Schachter, 1971, Some extraordinary facts about obese humans and rats, Am. Psychol., 26, 129, 10.1037/h0030817 Schachter, 1974 Boutelle, 2017, An open trial targeting food cue reactivity and satiety sensitivity in overweight and obese binge eaters, Cogn. Behav. Pract., 24, 363, 10.1016/j.cbpra.2016.08.003 Boutelle, 2011, Two novel treatments to reduce overeating in overweight children: a randomized controlled trial, J. Consult. Clin. Psychol., 79, 759, 10.1037/a0025713 Boutelle, 2014, An intervention based on Schachter’s externality theory for overweight children: the regulation of cues pilot, J. Pediatr. Psychol., 39, 405, 10.1093/jpepsy/jst142 Sheehan, 1998, The Mini-International Neuropspychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10, J. Clin. Psychiatry, 59, 22 Cooper, 1987, The eating disorder examination: semi-structured interview for the asessment of the specific psychopathology of eating disorders, Int. J. Eat. Disord., 6, 1, 10.1002/1098-108X(198701)6:1<1::AID-EAT2260060102>3.0.CO;2-9 Fairburn Berg, 2012, Psychometric evaluation of the eating disorder examination and eating disorder examination-questionnaire: a systematic review of the literature, Int. J. Eat. Disord., 45, 428, 10.1002/eat.20931 Fairburn, 2008, Eating disorder examination questionnaire (EDE-Q 6.0), 309 Fairburn, 1994, Assessment of eating disorders: interview or self-report questionnaire?, Int. J. Eat. Disord., 16, 363, 10.1002/1098-108X(199412)16:4<363::AID-EAT2260160405>3.0.CO;2-# Gormally, 1982, The assessment of binge eating severity among obese persons, Addict. Behav., 7, 47, 10.1016/0306-4603(82)90024-7 Timmerman, 1999, Binge eating scale: further assessment of validity and reliability, J. Appl. Biobehav. Res., 4, 10.1111/j.1751-9861.1999.tb00051.x Tylka, 2013, The intuitive eating scale-2: item refinement and psychometric evaluation with college women and men, J. Couns. Psychol., 60, 137, 10.1037/a0030893 Lowe, 2009, The power of food scale. A new measure of the psychological influence of the food environment, Appetite., 53, 114, 10.1016/j.appet.2009.05.016 Espel-Huynh, 2018, A narrative review of the construct of hedonic hunger and its measurement by the power of food scale, Obes. Sci. Pract., 1 Nederkoorn, 2000, Cephalic phase responses, craving and food intake in normal subjects, Appetite., 35, 45, 10.1006/appe.2000.0328 Malik, 1996, Heart rate variability. Standards of measurement, physiological interpretation, and clinical use, Eur. Heart J., 17, 354, 10.1093/oxfordjournals.eurheartj.a014868 Logan, 1994, On the ability to inhibit thought and action: A user’s guide to the stop signal paradigm, 189 Logan, 1984, On the ability to inhibit thought and action: a theory of an act of control, Psychol. Rev., 91, 295, 10.1037/0033-295X.91.3.295 Stunkard, 1985, The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger, J. Psychosom. Res., 29, 71, 10.1016/0022-3999(85)90010-8 Allison, 1992, A comparison of the psychometric properties of three measures of dietary restraint, Psychol. Assess., 4, 391, 10.1037/1040-3590.4.3.391 Diet History Questionnaire, 2010 2012 DHQ Nutrient Database. dhq2.database.092914.csv. National Cancer Institute, Epidemiology and Genomics Research Program.; Tanofsky-Kraff, 2008, Psychometric properties of a new questionnaire to assess eating in the absence of hunger in children and adolescents, Appetite., 51, 148, 10.1016/j.appet.2008.01.001 Blair, 1985, Assessment of habitual physical activity by a seven-day recall in a community survey and controlled experiments, Am. J. Epidemiol., 122, 794, 10.1093/oxfordjournals.aje.a114163 Gross, 1990, Reliability of interviewers using the seven-day physical activity recall, Res. Q. Exerc. Sport, 61, 321, 10.1080/02701367.1990.10607494 Dunn, 1999, Comparison of lifestyle and structured interventions to increase physical activity and cardiorespiratory fitness: a randomized trial, JAMA., 281, 327, 10.1001/jama.281.4.327 Godin, 1985, A simple method to assess exercise behavior in the community, Can. J. Appl. Sport Sci., 10, 141 Jacobs, 1993, A simultaneous evaluation of ten commonly used physical activity questionnaires, Med. Sci. Sports Exerc., 25, 81, 10.1249/00005768-199301000-00012 Fritz, 2007, Required sample size to detect the mediated effect, Psychol. Sci., 18, 233, 10.1111/j.1467-9280.2007.01882.x Preacher, 2008, Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models, Behav. Res. Methods, 40, 879, 10.3758/BRM.40.3.879 Benjamini, 1995, Controlling the false discovery rate: a practical and powerful approach to multiple testing, J. Royal Statist. Soc. B-Methodological., 57, 289 Gibbons, 1997, Random effects probit and logistic regression models for three-level data, Biometrics., 53, 1527, 10.2307/2533520 Fryar, 2018 Smith, 2010, Multicenter, placebo-controlled trial of lorcaserin for weight management, New Engl. J. Med., 363, 245, 10.1056/NEJMoa0909809 Burke, 2012, Using mHealth technology to enhance self-monitoring for weight loss: a randomized trial, Am. J. Prev. Med., 43, 20, 10.1016/j.amepre.2012.03.016 Jakicic, 2016, Effect of wearable technology combined with a lifestyle intervention on long-term weight loss: the IDEA randomized clinical trial, JAMA., 316, 1161, 10.1001/jama.2016.12858