Nutritional Video Intervention Using Mindfulness-based Principles

Simple Obesity Clinical Trial

Official title:

Healthy Plate Program in East and South Los Angeles: Testing "Mindfulness-inspired" Video in Community Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494661
• Other study ID #: UP-14-00591
• Status: Completed
• Phase: N/A
• First received: June 5, 2015
• Last updated: March 9, 2017
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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:

Related Conditions & MeSH terms

• Simple Obesity

Intervention

Behavioral:
• Healthy Cart and Stress Management Videos
Healthy Cart and Stress Management Videos: educational videos on healthy food shopping and stress reduction.
• Healthy Cart Video
Healthy Cart Video: educational video on healthy food shopping

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

References & Publications (16)

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. — View 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. Review. — View Citation

Cortés DE, Millán-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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Philipson T. The world-wide growth in obesity: an economic research agenda. Health Econ. 2001 Jan;10(1):1-7. Review. — View 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. Review. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nutritional knowledge at 2 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	Change in self-efficacy of healthy food shopping at 2 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
Secondary	Change in food shopping behavior at 2 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
Secondary	Change in mindful attention awareness at 2 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