- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494661
Nutritional Video Intervention Using Mindfulness-based Principles
March 9, 2017 updated by: Hortensia Amaro, University of Southern California
Healthy Plate Program in East and South Los Angeles: Testing "Mindfulness-inspired" Video in Community Settings
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- 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.
- 100% of data entries will be checked by Project specialist for accuracy.
- A total of 218 participants will be recruited to partake in the control condition Group A or Group B of the intervention.
- Because of the exploratory nature of the study, power calculations were not used to determine sample size.
- 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.
Study Type
Interventional
Enrollment (Actual)
218
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Identify as a Hispanic woman
- Ages: 18-55 years
- Responsible for buying groceries for family
- Language use: Ability to speak, read and write English or Spanish
- Resident in the USC's Health Sciences Campus and University Park Campus neighborhoods
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Cart and Stress Mangement Videos
Healthy Cart and Stress Management Videos: Participants receive two nutritional intervention videos: active comparator and managing stress while food shopping.
|
Healthy Cart and Stress Management Videos: educational videos on healthy food shopping and stress reduction.
|
Active Comparator: Healthy Cart Video
Healthy Cart Video: Participants receive one nutritional video intervention on how to shop for healthy foods using My Plate Guidelines.
|
Healthy Cart Video: educational video on healthy food shopping
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nutritional knowledge at 2 months
Time Frame: Two months
|
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.
|
Two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-efficacy of healthy food shopping at 2 months
Time Frame: Two months
|
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.
|
Two months
|
Change in food shopping behavior at 2 months
Time Frame: Two months
|
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.
|
Two months
|
Change in mindful attention awareness at 2 months
Time Frame: Two months
|
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.
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hortensia Amaro, PhD, University of Southern California
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
June 5, 2015
First Submitted That Met QC Criteria
July 7, 2015
First Posted (Estimate)
July 10, 2015
Study Record Updates
Last Update Posted (Actual)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 9, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-14-00591
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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