Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT02494661
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2015-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Video Intervention Using Mindfulness-based Principles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2015-06-05', 'studyFirstSubmitQcDate': '2015-07-07', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in nutritional knowledge at 2 months', 'timeFrame': 'Two months', 'description': 'All 218 participants will partake in a baseline questionnaire and a post questionnaire immediately following the video intervention to measure knowledge. A subsample of 29 participants from arm A and 39 participants from arm B will also complete a 2-month follow-up questionnaire to measure knowledge at the second time frame.'}], 'secondaryOutcomes': [{'measure': 'Change in self-efficacy of healthy food shopping at 2 months', 'timeFrame': 'Two months', 'description': 'All 218 participants will partake in a baseline questionnaire and a post questionnaire immediately following the video intervention to measure knowledge. A subsample of 29 participants from arm A and 39 participants from arm B will also complete a 2-month follow-up questionnaire to measure self-efficacy at the second time frame.'}, {'measure': 'Change in food shopping behavior at 2 months', 'timeFrame': 'Two months', 'description': '29 participants from arm A and 39 participants from arm B will be asked to turn in 2 grocery store receipts at initial intervention. They will also be asked back for a 2-month follow-up where they will turn in 2 additional receipts to measure changes in grocery shopping behavior.'}, {'measure': 'Change in mindful attention awareness at 2 months', 'timeFrame': 'Two months', 'description': '29 participants from arm A and 39 participants from arm B will be asked questions regarding mindful attention awareness at initial baseline questionnaire. In addition, they will be asked back for a 2-month follow-up questionnaire to measure changes in mindful attention awareness at the 2-month mark.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Public Health', 'Community', 'Obesity', 'Hispanic', 'Women', 'Nutrition', 'Mindfulness and stress', 'Food shopping'], 'conditions': ['Simple Obesity']}, 'referencesModule': {'references': [{'pmid': '23415192', 'type': 'BACKGROUND', 'citation': 'Cortes DE, Millan-Ferro A, Schneider K, Vega RR, Caballero AE. Food purchasing selection among low-income, Spanish-speaking Latinos. Am J Prev Med. 2013 Mar;44(3 Suppl 3):S267-73. doi: 10.1016/j.amepre.2012.11.012.'}, {'pmid': '14532317', 'type': 'BACKGROUND', 'citation': 'Narayan KM, Boyle JP, Thompson TJ, Sorensen SW, Williamson DF. Lifetime risk for diabetes mellitus in the United States. JAMA. 2003 Oct 8;290(14):1884-90. doi: 10.1001/jama.290.14.1884.'}, {'pmid': '20071470', 'type': 'BACKGROUND', 'citation': 'Ogden CL, Carroll MD, Curtin LR, Lamb MM, Flegal KM. Prevalence of high body mass index in US children and adolescents, 2007-2008. JAMA. 2010 Jan 20;303(3):242-9. doi: 10.1001/jama.2009.2012. Epub 2010 Jan 13.'}, {'pmid': '18083792', 'type': 'BACKGROUND', 'citation': 'Caballero AE, Bousquet-Santos K, Robles-Osorio L, Montagnani V, Soodini G, Porramatikul S, Hamdy O, Nobrega AC, Horton ES. Overweight Latino children and adolescents have marked endothelial dysfunction and subclinical vascular inflammation in association with excess body fat and insulin resistance. Diabetes Care. 2008 Mar;31(3):576-82. doi: 10.2337/dc07-1540. Epub 2007 Dec 14.'}, {'pmid': '17940434', 'type': 'BACKGROUND', 'citation': 'Caballero AE. Type 2 diabetes in the Hispanic or Latino population: challenges and opportunities. Curr Opin Endocrinol Diabetes Obes. 2007 Apr;14(2):151-7. doi: 10.1097/MED.0b013e32809f9531.'}, {'pmid': '16002835', 'type': 'BACKGROUND', 'citation': 'Drewnowski A, Darmon N. The economics of obesity: dietary energy density and energy cost. Am J Clin Nutr. 2005 Jul;82(1 Suppl):265S-273S. doi: 10.1093/ajcn/82.1.265S.'}, {'pmid': '12857541', 'type': 'BACKGROUND', 'citation': 'Hersey J, Anliker J, Miller C, Mullis RM, Daugherty S, Das S, Bray CR, Dennee P, Sigman-Grant M, Olivia AH. Food shopping practices are associated with dietary quality in low-income households. J Nutr Educ. 2001;33 Suppl 1:S16-26. doi: 10.1016/s1499-4046(06)60066-3.'}, {'pmid': '19298422', 'type': 'BACKGROUND', 'citation': 'Powell LM, Chaloupka FJ. Food prices and obesity: evidence and policy implications for taxes and subsidies. Milbank Q. 2009 Mar;87(1):229-57. doi: 10.1111/j.1468-0009.2009.00554.x.'}, {'pmid': '19523869', 'type': 'BACKGROUND', 'citation': 'Powell LM, Zhao Z, Wang Y. Food prices and fruit and vegetable consumption among young American adults. Health Place. 2009 Dec;15(4):1064-70. doi: 10.1016/j.healthplace.2009.05.002. Epub 2009 May 14.'}, {'pmid': '9787717', 'type': 'BACKGROUND', 'citation': 'Glanz K, Basil M, Maibach E, Goldberg J, Snyder D. Why Americans eat what they do: taste, nutrition, cost, convenience, and weight control concerns as influences on food consumption. J Am Diet Assoc. 1998 Oct;98(10):1118-26. doi: 10.1016/S0002-8223(98)00260-0.'}, {'pmid': '18173974', 'type': 'BACKGROUND', 'citation': 'Millan-Ferro A, Caballero AE. Cultural approaches to diabetes self-management programs for the Latino community. Curr Diab Rep. 2007 Oct;7(5):391-7. doi: 10.1007/s11892-007-0064-9.'}, {'pmid': '22074723', 'type': 'BACKGROUND', 'citation': 'Malik VS, Fung TT, van Dam RM, Rimm EB, Rosner B, Hu FB. Dietary patterns during adolescence and risk of type 2 diabetes in middle-aged women. Diabetes Care. 2012 Jan;35(1):12-8. doi: 10.2337/dc11-0386. Epub 2011 Nov 10.'}, {'pmid': '11180565', 'type': 'BACKGROUND', 'citation': 'Philipson T. The world-wide growth in obesity: an economic research agenda. Health Econ. 2001 Jan;10(1):1-7. doi: 10.1002/1099-1050(200101)10:13.0.co;2-1. No abstract available.'}, {'pmid': '21356146', 'type': 'BACKGROUND', 'citation': 'Katz DL, Doughty K, Njike V, Treu JA, Reynolds J, Walker J, Smith E, Katz C. A cost comparison of more and less nutritious food choices in US supermarkets. Public Health Nutr. 2011 Sep;14(9):1693-9. doi: 10.1017/S1368980011000048. Epub 2011 Feb 28.'}, {'pmid': '17595277', 'type': 'BACKGROUND', 'citation': 'Perrin JM, Bloom SR, Gortmaker SL. The increase of childhood chronic conditions in the United States. JAMA. 2007 Jun 27;297(24):2755-9. doi: 10.1001/jama.297.24.2755. No abstract available.'}, {'pmid': '15450626', 'type': 'BACKGROUND', 'citation': 'Drewnowski A. Obesity and the food environment: dietary energy density and diet costs. Am J Prev Med. 2004 Oct;27(3 Suppl):154-62. doi: 10.1016/j.amepre.2004.06.011.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to access the acceptability and potential utility of nutritional intervention videos in 1) changing knowledge and attitudes about healthy eating, 2) improving healthy food shopping practices, and 3) enhancing skills for stress reduction during food shopping among low-income Latina mothers.', 'detailedDescription': '* Low income Latina mothers (N=218) who are primary grocery shoppers for the family will be recruited through community based organization to take part in the study. Participation will include completion of survey instruments at baseline, immediately following the intervention; and a subset of participants (N=68) will also complete a 2-month follow-up survey and provide up to two weekly grocery store receipts from the prior 1-2 months at baseline and 2-month followup assessment points. The survey will collect data on demographics, knowledge about healthy eating, self efficacy, perceived stress and family history of relevant health issues. Grocery store receipts will be coded and used to evaluate pre-post changes in shopping of healthy vs unhealthy foods. The study compares two conditions: in the control condition, participants will view a 14-minute video on grocery shopping that teaches participants how to make healthy food choices. In the intervention condition, participants will view the aforementioned video in addition to a 15-minute video on how to manage stressors that arise during grocery shopping. -Surveys are to entered manually into chosen database by research assistant.\n* 100% of data entries will be checked by Project specialist for accuracy.\n* A total of 218 participants will be recruited to partake in the control condition Group A or Group B of the intervention.\n* Because of the exploratory nature of the study, power calculations were not used to determine sample size.\n* Group x time analyses will compare changes in knowledge, attitudes and self efficacy before and after exposure to the videos in the entire sample; and in the subsample followed for 2 months, compare baseline to 2-month followup changes in knowledge, attitudes, self efficacy, mindfulness and stress related measures as well as behavior change in food choices during grocery shopping.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Identify as a Hispanic woman\n* Ages: 18-55 years\n* Responsible for buying groceries for family\n* Language use: Ability to speak, read and write English or Spanish\n* Resident in the USC's Health Sciences Campus and University Park Campus neighborhoods\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT02494661', 'briefTitle': 'Nutritional Video Intervention Using Mindfulness-based Principles', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Healthy Plate Program in East and South Los Angeles: Testing "Mindfulness-inspired" Video in Community Settings', 'orgStudyIdInfo': {'id': 'UP-14-00591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Cart and Stress Mangement Videos', 'description': 'Healthy Cart and Stress Management Videos: Participants receive two nutritional intervention videos: active comparator and managing stress while food shopping.', 'interventionNames': ['Behavioral: Healthy Cart and Stress Management Videos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Cart Video', 'description': 'Healthy Cart Video: Participants receive one nutritional video intervention on how to shop for healthy foods using My Plate Guidelines.', 'interventionNames': ['Behavioral: Healthy Cart Video']}], 'interventions': [{'name': 'Healthy Cart and Stress Management Videos', 'type': 'BEHAVIORAL', 'description': 'Healthy Cart and Stress Management Videos: educational videos on healthy food shopping and stress reduction.', 'armGroupLabels': ['Healthy Cart and Stress Mangement Videos']}, {'name': 'Healthy Cart Video', 'type': 'BEHAVIORAL', 'description': 'Healthy Cart Video: educational video on healthy food shopping', 'armGroupLabels': ['Healthy Cart Video']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hortensia Amaro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Dean's Professor, Social Work and Preventive Medicine, Associate Vice Provost, Community Research Initiatives", 'investigatorFullName': 'Hortensia Amaro', 'investigatorAffiliation': 'University of Southern California'}}}}