Simple ObesityNCT02494661
Nutritional Video Intervention Using Mindfulness-based Principles
A study testing Healthy Cart and Stress Management Videos and Healthy Cart Video in people with Simple Obesity, run by University of Southern California.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Simple Obesity
- What is being tested?
- Healthy Cart and Stress Management Videos and Healthy Cart Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: 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.
Read the 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.
- Conditions
- Simple Obesity
- Being tested
- Healthy Cart and Stress Management Videos, Healthy Cart Video
- Keywords
- Public Health, Community, Obesity, Hispanic, Women, Nutrition, Mindfulness and stress, Food shopping
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Cart and Stress Management VideosBehavioural
Healthy Cart and Stress Management Videos: educational videos on healthy food shopping and stress reduction.
Healthy Cart VideoBehavioural
Healthy Cart Video: educational video on healthy food shopping
| Study group | Role | What they receive |
|---|---|---|
| Healthy Cart and Stress Mangement Videos | Experimental | Healthy Cart and Stress Management Videos: Participants receive two nutritional intervention videos: active comparator and managing stress while food shopping. Receives: Behavioral: Healthy Cart and Stress Management Videos |
| Healthy Cart Video | Active comparator | Healthy Cart Video: Participants receive one nutritional video intervention on how to shop for healthy foods using My Plate Guidelines. Receives: Behavioral: Healthy Cart Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two months
Secondary outcomes (3)
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.
Measured: Two months
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.
Measured: Two months
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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Simple ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hortensia Amaro, University of Southern California
- Investigators
- Hortensia Amaro, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494661
- Sponsor's protocol ID
- UP-14-00591
- Status last verified
- Mar 2017
- First submitted
- 5 Jun 2015
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23415192Narayan 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.
PubMed 14532317Ogden 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.
PubMed 20071470Caballero 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.
PubMed 18083792Caballero 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.
PubMed 17940434Drewnowski 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.
PubMed 16002835Hersey 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.
PubMed 12857541Powell 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.
PubMed 19298422Powell 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.
PubMed 19523869Glanz 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.
PubMed 9787717Millan-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.
PubMed 18173974Malik 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.
PubMed 22074723Philipson 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.
PubMed 11180565Katz 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.
PubMed 21356146Perrin 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.
PubMed 17595277
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Plate Program in East and South Los Angeles: Testing "Mindfulness-inspired" Video in Community Settings
- ClinicalTrials.gov ID
- NCT02494661
- Acronym / sponsor ID
- UP-14-00591
- Conditions
- Simple Obesity
- Keywords
- Public Health, Community, Obesity, Hispanic, Women, Nutrition, Mindfulness and stress, Food shopping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Cart and Stress Mangement Videos | Experimental | Behavioral: Healthy Cart and Stress Management VideosHealthy Cart and Stress Management Videos: Participants receive two nutritional intervention videos: active comparator and managing stress while food shopping. |
| Healthy Cart Video | Active comparator | Behavioral: Healthy Cart VideoHealthy Cart Video: Participants receive one nutritional video intervention on how to shop for healthy foods using My Plate Guidelines. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Cart and Stress Management VideosHealthy Cart and Stress Management Videos: educational videos on healthy food shopping and stress reduction. | Behavioural | Healthy Cart and Stress Mangement Videos |
| Healthy Cart VideoHealthy Cart Video: educational video on healthy food shopping | Behavioural | Healthy Cart Video |
Primary outcome
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.
3 secondary outcomes
Change in self-efficacy of healthy food shopping at 2 months
Time frame: Two months
Change in food shopping behavior at 2 months
Time frame: Two months
Change in mindful attention awareness at 2 months
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Background: PubMed 23415192Cortes 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.
- Background: PubMed 14532317Narayan 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.
- Background: PubMed 20071470Ogden 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.
- Background: PubMed 18083792Caballero 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.
- Background: PubMed 17940434Caballero 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.
- Background: PubMed 16002835Drewnowski 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.
- Background: PubMed 12857541Hersey 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.
- Background: PubMed 19298422Powell 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.
- Background: PubMed 19523869Powell 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.
- Background: PubMed 9787717Glanz 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.
- Background: PubMed 18173974Millan-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.
- Background: PubMed 22074723Malik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hortensia Amaro, PhD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Cart and Stress Management Videos and Healthy Cart Video in people with Simple Obesity, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutritional knowledge at 2 months (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494661, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.