Impact of Mindfulness Program on Perceived Wellness, Eating Habits and Relationship to Food
Case Controlled Blind Randomized Study on Impact of Nutrition and Mental Health Counseling With Mindfulness Program on Perceived Wellness, Dietary Practices and Relationship to Food.
1 other identifier
interventional
500
0 countries
N/A
Brief Summary
Mindfulness, seemingly a simple concept, research shows that the impact of mindfulness on the overall wellness of an individual can be helpful (5). Research supports that mindfulness leads to reduced stress, enhanced performance, better focus, and improved approach (7). Areas of mindfulnessare mindful eating,movement and meditation. Application of mindfulness tools in these areas can be beneficial to health outcomes and to create a happier more efficient work environment (9). Mindful eating shows to improve diet quality and attitudes toward food and eating. Individuals better understand physical hunger/fullness cues, improve nutrient density, weight control,digestion,systolic blood pressure, and stress(2). Disordered eating behaviors have also shown to improve(3). Mindless eating, such as eating while being on the phone, driving, or watching television can have the opposite effect and can be linked to more emotional hunger cues. Combining mindful eating with diet therapy can lead to healthier food choices and a more positive feeling towards eating and body image, reducing stress and improving the overall wellness of an individual (4). Aspire's experience shows that aspects of teacher's wellness is worsening with ,media reporting more and more employees resigning from their positions every day (wccb,2021). Teachers have voiced their need for more support with their wellbeing. As a result, Aspire Nutrition is targeting school employees through a newly developed mindfulness program titled Nourish Carolina. This program will be focused on improving the overall wellness of participants Participants are enrolled in the study for 12 weeks. All participants will have weekly nutritional counseling and bi-weekly mental health counseling. Study group will have nutrition and mental health counseling with mindfulness activities and control group will receive nutrition and mental health sessions without mindfulness activities. There is a program curriculum so that mental health and nutrition mindfulness activities compliment eachother The mindfulness lessons for study group are divided into 6 nutrition and 6 mental health sessions,for 15 minutes during the session. Positive outcomes could include improved workplace performance as a result of enhancing school employees overall wellness and quality of life by reducing stress levels, improving diet quality, and improving mental health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2021
CompletedStudy Start
First participant enrolled
February 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedFebruary 10, 2022
January 1, 2022
3 months
December 21, 2021
January 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Impact on relationship to food from Mindfulness Program, Nourish Carolina - Comparison of study group with Control Group, using IES2 and clinical reports from nutrition sessions
Measured using Intuitive Eating Scale - 2 (IES2) to assess individual's change with their relationship with food. IES2 is widely used and accepted measure developed by Tracy L Tylka Ph D. with Ohio State University. Data collected will be measured as a scale for questionnaires. The scoring procedure is outlined at the bottom of the IES2 and is calculated as a whole number. Standard Clinical Templates in Simple Practice for note taking during session provide subjective and objective observations for nutrition sessions both control and study group.
IES2 at end of the study -12 weeks. Standard Clinical Templates in Simple Practice for note taking during session provide subjective and objective observations for nutrition sessions both control and study group.
Impact on Percieved Wellness from Mindfulness program , Nourish Carolia - Comparison of Study Group with Control Group using BIS2, RAND36, and Clinical reports from treatment sessions, mental health and nutrition
Body Image Scale-2 (BIS 2)scoring procedure for the BIS2 will be reflected as a relative scale of all the participants. Perceived wellness is measured by RAND 36 Item Health Survey. The RAND-36 survey is widely accepted and consists of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. provides information on what a clinically important difference is for the RAND-36 scales, and provides guidance for summarizing the RAND-36 in a single number.Standard clinical templates recorded and stored in Simple Practice for note taking during session provide subjective and objective observations for nutrition sessions both control and study group in nutrition and mental health sessions
These measurements are assessed at the end of the study -12 weeks. Weekly nutrition and biweekly mental health notes for nutrition sessions both control and treatment groups
Secondary Outcomes (14)
Impact of Mindfulness Program on Meals per day
Assessed at the end of the study -12 weeks.
Imact of Mindfulness Program on Snacks per day
Assessed 12 weeks.
Impact of Mindfulness Program on Food Choices
Assessed at 12 weeks.
Impact of Mindfulness Program on Food Rules
Assessed at 12 weeks.
Impact of Mindfulness Program on emotional eating
Assessed at 12 weeks.
- +9 more secondary outcomes
Study Arms (2)
Impact of Nourish Carolina - Control Group
EXPERIMENTALGroup A - nutrition (one time/week) and mental health counseling (biweekly) for 12 weeks
Impact of Nourish Carolina - Study Group
EXPERIMENTALGroup B - nutrition ( one time/week) and mental health counseling (biweekly)with Nourish Carolina for 12 weeks
Interventions
Nutrition and Mental health counseling with a standardized format included in each session
Nutrition and Mental health counseling with a standardized format included in each session combined with the intervention of a 12 week immersion of mindfulness based program ,Nourish Carolina, on CMS , school district employees. Nourish Carolina inlcudes, detailed lessons and descriptions with a caledar that includes mindful eating tips, activities, meditations recipes and videos. The program has monthly themes of mindfulness,gratitude and giving
Eligibility Criteria
You may qualify if:
- School staff members - including all grade levels and positions of elementary, middle and high schools of North Carolina
- Must be able to attend virtual sessions scheduled visits.
- Must be 21 years old
You may not qualify if:
- Not an school district employee
- Can not attend virtual session scheduled visits
- An individual who would require a LAR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (10)
Shapiro SL, Carlson LE, Astin JA, Freedman B. Mechanisms of mindfulness. J Clin Psychol. 2006 Mar;62(3):373-86. doi: 10.1002/jclp.20237.
PMID: 16385481BACKGROUNDAdams T, Bezner J, Steinhardt M. The conceptualization and measurement of perceived wellness: integrating balance across and within dimensions. Am J Health Promot. 1997 Jan-Feb;11(3):208-18. doi: 10.4278/0890-1171-11.3.208.
PMID: 10165100BACKGROUNDSharma, Praveen Kumar, and Rajeev Kumra. "Relationship between Mindfulness, Depression, Anxiety and Stress: Mediating Role of Self-Efficacy." Personality and Individual Differences, vol. 186, 2022, p. 111363., https://doi.org/10.1016/j.paid.2021.111363.
BACKGROUNDSala M, Vanzhula I, Roos CR, Levinson CA. Mindfulness and Eating Disorders: A Network Analysis. Behav Ther. 2022 Mar;53(2):224-239. doi: 10.1016/j.beth.2021.07.002. Epub 2021 Aug 5.
PMID: 35227400BACKGROUNDAlamout MM, Rahmanian M, Aghamohammadi V, Mohammadi E, Nasiri K. Effectiveness of mindfulness based cognitive therapy on weight loss, improvement of hypertension and attentional bias to eating cues in overweight people. Int J Nurs Sci. 2019 Dec 27;7(1):35-40. doi: 10.1016/j.ijnss.2019.12.010. eCollection 2020 Jan 10.
PMID: 32099857BACKGROUNDWilson RE, Marshall RD, Murakami JM, Latner JD. Brief non-dieting intervention increases intuitive eating and reduces dieting intention, body image dissatisfaction, and anti-fat attitudes: A randomized controlled trial. Appetite. 2020 May 1;148:104556. doi: 10.1016/j.appet.2019.104556. Epub 2020 Jan 1.
PMID: 31901439BACKGROUNDOliver A, Hooper S, Lau R, Hutchinson A. Effect of a multidisciplinary rehabilitation program for patients receiving weight management interventions on eating behaviours and health-related quality of life. Obes Res Clin Pract. 2021 May-Jun;15(3):268-274. doi: 10.1016/j.orcp.2021.03.006. Epub 2021 Mar 15.
PMID: 33736958BACKGROUNDGodde JU, Yuan TY, Kakinami L, Cohen TR. Intuitive eating and its association with psychosocial health in adults: A cross-sectional study in a representative Canadian sample. Appetite. 2022 Jan 1;168:105782. doi: 10.1016/j.appet.2021.105782. Epub 2021 Nov 3.
PMID: 34740711BACKGROUNDCancelliere C, Cassidy JD, Ammendolia C, Cote P. Are workplace health promotion programs effective at improving presenteeism in workers? A systematic review and best evidence synthesis of the literature. BMC Public Health. 2011 May 26;11:395. doi: 10.1186/1471-2458-11-395.
PMID: 21615940BACKGROUNDPenalvo JL, Sagastume D, Mertens E, Uzhova I, Smith J, Wu JHY, Bishop E, Onopa J, Shi P, Micha R, Mozaffarian D. Effectiveness of workplace wellness programmes for dietary habits, overweight, and cardiometabolic health: a systematic review and meta-analysis. Lancet Public Health. 2021 Sep;6(9):e648-e660. doi: 10.1016/S2468-2667(21)00140-7.
PMID: 34454642BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaylee Patrick, RD/LDN
Aspire Nutrition Owner
- STUDY DIRECTOR
Cyrilla E Purnell, MPH, RD
Program Management and Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participants will know only that they have been selected for a study but not what group they are in or what the study is investigating. The administrators of the study will know what clients have been assigned the study and what participants are in the control group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2021
First Posted
February 10, 2022
Study Start
February 2, 2022
Primary Completion
May 15, 2022
Study Completion
September 15, 2022
Last Updated
February 10, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- The data will be made available October 15, 2022
- Access Criteria
- All inquries will be allowed access
The information will be made available to other researchers on the Aspire Nutrition website and will be presented at the FENCE nutrition conference next year if application is accepted