Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2017-10-28
2018-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Personalized dietary and wellness program
An integrated personalized nutrition program which includes a combination of dietary and wellness advice/counseling on wellness and meals, or dietary and wellness advice/counseling alone, each for 10 weeks.
Personalized dietary and wellness program
Single arm intervention containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only
Interventions
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Personalized dietary and wellness program
Single arm intervention containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only
Eligibility Criteria
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Inclusion Criteria
* BMI 18.5-39.9 kilograms per meters squared.
* Willing to follow study program instructions, including consumption of meals on site (5 days/week; breakfast and lunch), consumption of all provided meals, use of a Fitbit®, self-administered capillary blood draws and dried blood spot collection, and visit schedule, where relevant.
* Willing and able to comply with the visit/contact schedule.
* Willing to avoid vigorous activity and alcohol consumption (24 h) and willing to fast (10-14 h, water only) prior to completion of the at-home oral protein glucose lipid tolerance test.
* Normally active and judged to be in good health on the basis of the medical history.
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.
* Subject has access to an internet-ready device and email.
Exclusion Criteria
* A history or presence of a gastrointestinal condition that could potentially interfere with digestion and absorption of the study product including, inflammatory bowel disease, irritable bowel syndrome, chronic constipation, and history of frequent diarrhea; and gastroparesis.
* Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
* A history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
* A history of unconventional sleep patterns.
* Major trauma or a surgical event within 3 months of screening.
* Nicotine users.
* Use of medications which can alter the lipid profile with the exception of stable statin use.
* Unstable use of any thyroid medication.
* Use of antibiotics, hypoglycemic medications, and/or systemic corticosteroids.
* Signs or symptoms of an active infection.
* Current or recent history of drug or alcohol abuse.
* Known allergy and/or sensitivity to the study foods or products.
* Extreme dietary habits (e.g., very high protein diets, vegan, very low carbohydrate, etc.).
* A change (increase or decrease) in body weight of \>10%.
* Females who are pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
* Study staff or those who will be involved in the conduct of the study.
30 Years
65 Years
ALL
Yes
Sponsors
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TNO
OTHER
University of California, San Diego
OTHER
Habit, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Joshua C Anthony, PhD
Role: PRINCIPAL_INVESTIGATOR
Habit, LLC
Barbara L Winters, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
Winters Nutrition Associates LLC
Kristin M Nieman, PhD
Role: STUDY_DIRECTOR
Katalyses LLC
Locations
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Campbell Soup Company
Camden, New Jersey, United States
Countries
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References
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Blaak EE, Hul G, Verdich C, Stich V, Martinez A, Petersen M, Feskens EF, Patel K, Oppert JM, Barbe P, Toubro S, Anderson I, Polak J, Astrup A, Macdonald IA, Langin D, Holst C, Sorensen TI, Saris WH. Fat oxidation before and after a high fat load in the obese insulin-resistant state. J Clin Endocrinol Metab. 2006 Apr;91(4):1462-9. doi: 10.1210/jc.2005-1598. Epub 2006 Jan 31.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
Hardcastle SJ, Taylor AH, Bailey MP, Harley RA, Hagger MS. Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention follow-up. Int J Behav Nutr Phys Act. 2013 Mar 28;10:40. doi: 10.1186/1479-5868-10-40.
Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
Hunot C, Fildes A, Croker H, Llewellyn CH, Wardle J, Beeken RJ. Appetitive traits and relationships with BMI in adults: Development of the Adult Eating Behaviour Questionnaire. Appetite. 2016 Oct 1;105:356-63. doi: 10.1016/j.appet.2016.05.024. Epub 2016 May 20.
Johnson RK. Dietary intake--how do we measure what people are really eating? Obes Res. 2002 Nov;10 Suppl 1:63S-68S. doi: 10.1038/oby.2002.192. No abstract available.
Kardinaal AF, van Erk MJ, Dutman AE, Stroeve JH, van de Steeg E, Bijlsma S, Kooistra T, van Ommen B, Wopereis S. Quantifying phenotypic flexibility as the response to a high-fat challenge test in different states of metabolic health. FASEB J. 2015 Nov;29(11):4600-13. doi: 10.1096/fj.14-269852. Epub 2015 Jul 21.
Kolodziejczyk JK, Norman GJ, Roesch SC, Rock CL, Arredondo EM, Madanat H, Patrick K. Exploratory and confirmatory factor analyses and demographic correlate models of the strategies for weight management measure for overweight or obese adults. Am J Health Promot. 2015 Mar-Apr;29(4):e147-57. doi: 10.4278/ajhp.130731-QUAN-391. Epub 2014 Mar 26.
Kristal AR, Kolar AS, Fisher JL, Plascak JJ, Stumbo PJ, Weiss R, Paskett ED. Evaluation of web-based, self-administered, graphical food frequency questionnaire. J Acad Nutr Diet. 2014 Apr;114(4):613-21. doi: 10.1016/j.jand.2013.11.017. Epub 2014 Jan 24.
Resnicow K, McMaster F. Motivational Interviewing: moving from why to how with autonomy support. Int J Behav Nutr Phys Act. 2012 Mar 2;9:19. doi: 10.1186/1479-5868-9-19.
Stewart EE, Fox CH. Encouraging patients to change unhealthy behaviors with motivational interviewing. Fam Pract Manag. 2011 May-Jun;18(3):21-5. No abstract available.
Stich C, Knauper B, Tint A. A scenario-based dieting self-efficacy scale: the DIET-SE. Assessment. 2009 Mar;16(1):16-30. doi: 10.1177/1073191108322000. Epub 2008 Aug 14.
Stroeve JHM, van Wietmarschen H, Kremer BHA, van Ommen B, Wopereis S. Phenotypic flexibility as a measure of health: the optimal nutritional stress response test. Genes Nutr. 2015 May;10(3):13. doi: 10.1007/s12263-015-0459-1. Epub 2015 Apr 21.
Teeter BS, Kavookjian J. Telephone-based motivational interviewing for medication adherence: a systematic review. Transl Behav Med. 2014 Dec;4(4):372-81. doi: 10.1007/s13142-014-0270-3.
van Amelsvoort JM, van Stratum P, Kraal JH, Lussenburg RN, Houtsmuller UM. Effects of varying the carbohydrate:fat ratio in a hot lunch on postprandial variables in male volunteers. Br J Nutr. 1989 Mar;61(2):267-83. doi: 10.1079/bjn19890115.
van Ommen B, van der Greef J, Ordovas JM, Daniel H. Phenotypic flexibility as key factor in the human nutrition and health relationship. Genes Nutr. 2014 Sep;9(5):423. doi: 10.1007/s12263-014-0423-5. Epub 2014 Aug 9.
Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
Related Links
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Institute of Medicine - Dietary Reference Intakes
World Health Organization - Physical Activity Definitions
World Health Organization: Waist and Hip Circumference Ratio
Other Identifiers
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Habit-1701
Identifier Type: -
Identifier Source: org_study_id
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