Clinical trial NCT05233046: Impact of Mindfulness Program on Perceived Wellness, Eating Habits and Relationship to Food
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet, Healthy
Food Habits
Mental Fatigue
Mental Stress
Mental Health Issue
Nutrition Poor
Nutrition Disorders
Eating, Compulsive
Eating Behavior
Eating Disorder Weight Fixation
Eating Disorders
Nutrition, Healthy
Dietary Habits
Keywords: diet
nutrition
counseling
mental health
physical health
work
stress
Lead sponsor: Aspire Nutrition, LLP
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couseling sessions provided by RDs and licensed board certified mental health professionals are trained with standard protocol and evaluated individually. Training protocol includes handbook and virtual instruction with motivational interviewing techniques like using open-ended questions.

Both study and control group a counseled with standard protocol that includes weekly nutrition services and biweekly mental health services. Study group receives counseling sessions combined with Nourish Carolina program. Control group won't be taught mindfulness-based concepts.

Standardized focus includes all participants are presented essential nutrition concepts. Also, nutrition and mental health mindfulness sessions will be coordinated and will compliment each other. Each week designed so that the mindful based mini-exercises outlined in Nourish Carolina will have the same theme for both nutrition and mental health sessions.
Primary purpose: TREATMENT

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.

Detailed description: Introduction:

Mindfulness is the cultivation of tools and skills that help navigate thoughts, emotions, increase awareness, and be present in the moment. Cultivating mindfulness involves practice and patience using exercises that strengthen the ability to focus (7). Among the many benefits are self-control, objectivity, improved focus, mental clarity and emotional intelligence(5). As a tool for overall wellness, mindfulness has been beneficial. Mindfulness, a state of mind,appears to impact health and wellness in a powerful way (1). Researchers have concluded that self-rated perceptions of health are among the most powerful predictors of subsequent health outcomes (8). When combined with a holistic approach, mindfulness can enhance perceived wellness and improve workplace culture(8).

Mindful eating emphasizes awareness of internal and external sensations and emotions. Studies reveal that mindful eating strategies can lead to weight stabilization, improved digestion, stress reduction, improvements with binge eating episodes and disordered eating establishing an overall better relationship with food (2). Interest in mindful eating has grown as a strategy to eat with less distractions and to improve eating behaviors. The current research supports that combining behavioral strategies such as mindfulness training with nutrition education can lead to an improved relationship with food that reduces risk of chronic disease, promotes more food enjoyment and supports a healthy body image(1). Studies show that mindfulness can be an effective tool in the treatment of unfavorable behaviors such as emotional eating and binge eating(3). Mindfulness addresses shame/guilt often associated with disordered eating behaviors through encouraging nonjudgmental attitudes (3). Mindfulness training develops the skills needed for awareness of thoughts and emotions and non-judgemental acceptance (1) as a result, improvement in abilities to cope emotions that impact overall wellbeing.

What is the project about :

Aspire Nutrition provides nutrition and mental health counseling to teachers throughout North Carolina. Many teachers have expressed an interest in more support with their overall wellness. Over 500 teachers have resigned over the past two months and continue to quit (wccb,2021). In addition to the many challenges that schools face, many staff members are voicing a need for more support with individual wellness and improvements in the work place environment. This study will focus on establishment of a standardized wellness program, Nourish Carolina, with aims to improve self reported dietary habits and perceived wellness of school employees including teachers, administrative staff, cafeteria staff and all other employees.

The Nourish Carolina program encompases both nutrition and mental health counseling with an emphasis on recruitment of skills/tools necessary to cultivate mindfulness in each session. Each participant will participate in the study for three months (12 weeks). There will be a treatment group and a control group. The treatment group will receive both virtual nutrition and mental health counseling with 15 minutes of mindfulness work in each session. The control group will receive virtual nutrition and mental health counseling without any mindfulness support. The participants will attend weekly nutrition sessions and biweekly mental health sessions. This project is designed to investigate the outcomes of the combined nutrition and mental health counseling with an application of mindfulness skills compared to a control group that only receives counseling services with no mindfulness training. The nutrition counseling sessions will be provided by registered and licensed dietitians. Mental health counseling sessions will be provided by licensed, board certified mental health professionals. The treatment group will be the only group to receive both nutrition and mental health counseling with professional support of mindfulness adaptations.To ensure participants receive the same experience, the mental health mindfulness lessons and the nutrition mindfulness lessons and activities will be coordinated so that these lessons focus on similar concepts within the scope of mindfulness. Each weekly nutrition session in both the treatment group and the control group will include standard Nutrition Lesson Plans. Examples of educational concepts included in a standard lesson are as follows: dietary variety, meal planning, grocery shopping, label reading, healthy snacking, and macronutrients.

Hypothesis:

Nourish Carolina program and mindfulness practices introduced in mental health and nutrition counseling sessions will benefit participants by enhancing relationship to food, diet quality and mental health(stress levels).

Our Approach:

Nourish Carolina, is a three month mindfulness program designed to support the health and wellness of teachers by providing nutrition and mental health counseling combined with cultivating skills and the development of tools encouraging mindfulness. The program duration is 12 weeks. The concepts within the program focuses on mindfulness, gratitude and giving. Lesson Plans for nutrition (6 lessons) and mental health (6 lessons) services are provided for the practitioners to introduce during counseling sessions with the participants in the study group. Participants in the control group will not receive mindfulness activities unless it is the appropriate clinical alternative that a client requires.

Each participant will participate in the study for three months. There will be a treatment group and a control group. The treatment group will receive both virtual nutrition and mental health counseling with 15 minutes allocated towards development of mindfulness skills and tools included into each session. The control group will receive virtual nutrition and mental health counseling sessions without any mindful-based support. The participants will attend weekly nutrition sessions and biweekly mental health sessions. This project is designed to investigate the outcomes of combined nutrition and mental health counseling with a focused approach towards cultivation of mindful based skills, compared to a control group, in order to study changes in dietary habits and perceived wellness.

Registered dietitians and licensed, board certified mental health professionals will be trained with a standard protocol. The training protocol for all providers will include a protocol handbook and virtual, group instruction. Virtual training will include motivational interviewing with a special emphasis on using open-ended questions. Nutrition Lesson Plans with prompts for motivational interviewing, Mindfulness Activities ( Both Nutrition and Mental Health) and appropriate handouts are all included in the Nourish Carolina Handbook. All providers will have a handbook. Proper use of the format will be evaluated by performance evaluations during the virtual training.

The treatment group and control group will both experience the same standard nutrition protocol with standardized Lesson Plans and appropriate nutrition counseling.The treatment group and the control group will both have mental health counseling.The treatment group will be the only group to receive the immersion of mindfulness based concepts throughout their nutrition and mental health counseling sessions.

Participant Recruiting:

All school staff members that work at elementary, middle and high schools throughout the district will be informed about the study and are eligible for participation.

Participants will be recruited through email, word of mouth, meetings at individual schools, and support of the district itself. Eligible participants will have the opportunity to sign up to participate in the study on Aspire Nutrition's website: https://www.aspire- nutrition.com/. Randomization of participants will be used to allocate group selection.

Participants will be assigned to the treatment or control group based on the order their application was received. For clarification, the first 10 subjects will be assigned to the control group, the next 10 will be assigned to the treatment group, and so on. All participants must sign a mandatory consent form before participating in the study. Each participant will be able to sign the consent forms electronically . All outstanding questions concerning consent forms will be addressed by telephone or by a virtual zoom orientation. All of a participant's questions will be addressed thoroughly and completely before signing the consent forms. In addition, as the study progresses, if a participant has any questions or complaints that a practitioner can't address, contact Cyrilla Purnell, MPH, RD, LDN Email : research@aspire-nutrition.com Phone: (704) 819-0050

There will be 500 participants for each round of the study. There may be 3-5 trials conducted to reach the desired goal of 2000 total participants.Each participant will be required to complete the 12 week program within 3 months. There will be 3-5 study sessions, to complete the allocated study participant goal.Each participant will be given an extra month grace period to cover weeks they were not able to attend.

Program Evaluation:

All communication with participants and information collected will be conducted through a HIPPA compliant platform. Each participant will be informed on the process of the study, and the requirements and their commitment. Each participant will be assessed with a standard initial consultation. During the initial consultation the participant will have the opportunity to discuss and formulate individual goals and share concerns and experiences. A pre and post evaluation will be administered based on accepted indicators of food choices, nutrition knowledge, and perceived wellness.The questionnaires selected are well validated and widely used to collect information.

Aspire Nutrition will use focus groups to help further develop the study. The focus groups will be used to determine the needs of the school community and the problems faced in the workplace and with wellness . As perceptions of wellness are individualized and specific to a population, the focus group will provide insight regarding the specific population being studied and their perceptions of wellness. The focus groups will be held virtually and will host participants throughout the school district. There will be two virtual focus groups.

What we have done:

Aspire Nutrition has actively worked with teachers since June 2021. Throughout the months of counseling sessions, the team has established relationships with school employees revealing a need for increased support for teachers. In response to this need Aspire Nutrition has partnered with Eat Smart, Move More, a resource tool to encourage healthy choices. In addition,since previous clients respond positively to mindfulness education so mindfulness activities are used in sessions, Upon conducting research on mindful eating and the benefits of incorporating mindfulness into therapeutic nutrition and mental health sessions, the investigator developed a 12 week mindfulness program, Nourish Carolina. This investigation studies the outcomes of Nourish Carolina in a meaningful and beneficial way.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Not an school district employee
* Can not attend virtual session scheduled visits
* An individual who would require a LAR

Primary outcomes:
measure: 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
timeFrame: 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.
measure: 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
timeFrame: 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:
measure: Impact of Mindfulness Program on Meals per day
timeFrame: Assessed at the end of the study -12 weeks.
measure: Imact of Mindfulness Program on Snacks per day
timeFrame: Assessed 12 weeks.
measure: Impact of Mindfulness Program on Food Choices
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on Food Rules
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on emotional eating
timeFrame: Assessed at 12 weeks.
measure: Impactof Mindfulness Program on body trust
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on health rating
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on exercise frequency
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on desire to work
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on feelings of wellbeing
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program onl daiy movement
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on stress management
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on anxiety level
timeFrame: Assessed at 12 weeks.
measure: Impact of Mindfulness Program on body image
timeFrame: Assessed 12 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Aspire Nutrition Owner
name: Kaylee Patrick, RD/LDN
role: PRINCIPAL_INVESTIGATOR
affiliation: Program Management and Development
name: Cyrilla E Purnell, MPH, RD
role: STUDY_DIRECTOR
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