Nutritional Video Intervention Using Mindfulness-based Principles
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|ClinicalTrials.gov Identifier: NCT02494661|
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Simple Obesity||Behavioral: Healthy Cart and Stress Management Videos Behavioral: Healthy Cart Video||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Healthy Plate Program in East and South Los Angeles: Testing "Mindfulness-inspired" Video in Community Settings|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
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.
Behavioral: Healthy Cart and Stress Management Videos
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.
Behavioral: Healthy Cart Video
Healthy Cart Video: educational video on healthy food shopping
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494661
|Principal Investigator:||Hortensia Amaro, PhD||University of Southern California|