Skip to main content
Clinical Trials/NCT05233046
NCT05233046UnknownNot Applicable

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.

Aspire Nutrition, LLP0 sites500 target enrollmentStarted: February 2, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
500
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

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.

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Impact of Nourish Carolina - Control Group

Experimental

Group A - nutrition (one time/week) and mental health counseling (biweekly) for 12 weeks

Intervention: Nutrition and Mental health counseling (Behavioral)

Impact of Nourish Carolina - Study Group

Experimental

Group B - nutrition ( one time/week) and mental health counseling (biweekly)with Nourish Carolina for 12 weeks

Intervention: Nutrition and Mental health counseling with Nourish Carolina (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: 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

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

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

Time Frame: 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.

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.

Secondary Outcomes

  • Impact of Mindfulness Program on Food Choices(Assessed at 12 weeks.)
  • Impact of Mindfulness Program on Food Rules(Assessed at 12 weeks.)
  • Impactof Mindfulness Program on body trust(Assessed at 12 weeks.)
  • Impact of Mindfulness Program on exercise frequency(Assessed at 12 weeks.)
  • 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 emotional eating(Assessed at 12 weeks.)
  • Impact of Mindfulness Program on stress management(Assessed at 12 weeks.)
  • Impact of Mindfulness Program on health rating(Assessed at 12 weeks.)
  • Impact of Mindfulness Program on body image(Assessed 12 weeks.)
  • Impact of Mindfulness Program on desire to work(Assessed at 12 weeks.)
  • Impact of Mindfulness Program on feelings of wellbeing(Assessed at 12 weeks.)
  • Impact of Mindfulness Program onl daiy movement(Assessed at 12 weeks.)
  • Impact of Mindfulness Program on anxiety level(Assessed at 12 weeks.)

Investigators

Sponsor
Aspire Nutrition, LLP
Sponsor Class
Other
Responsible Party
Sponsor

Similar Trials