University of Georgia Mind Your Heart Pilot Study

NCT07670910 | Completed

• 1 other identifier: PROJECT00003799
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn if nutrition education can improve eating habits and health outcomes in adults. The main questions it aims to answer are:

• Blood draws to measure blood lipids (e.g., cholesterol)
• Blood pressure measurement
• Eye exams to assess nutrient levels
• Completion of questionnaires about dietary habits
• Complete online questionnaires before and after the study period
• Participate in the Mind Your Heart program by reviewing 6 online modules over 6 weeks (approximately 20-30 minutes per module)

Conditions

Hypertension (HTN); Obesity & Overweight

Keywords

Mindful eating; DASH diet; eHealth

Outcome Measures

Primary Outcomes (4)

• Change in DASH Diet Score

  Change in DASH diet adherence from baseline to 6 weeks was measured using the Dietary Approaches to Stop Hypertension (DASH) Diet Accordance Score. Dietary intake data were collected using MyFitnessPal and used to calculate adherence to nine DASH nutrient targets: total fat, saturated fat, protein, cholesterol, fiber, calcium, magnesium, sodium, and potassium. Each nutrient is scored as 0 (poor adherence), 0.5 (fair adherence), or 1 (compliant with the DASH target). Scores for all nine nutrients are summed to generate a total DASH Diet Accordance Score ranging from 0 to 9, with higher scores indicating greater adherence to DASH dietary recommendations and a more heart-healthy dietary pattern.

  Baseline to 6 weeks

• Change in Three Factor Eating Questionnaire

  Change in eating behaviors from baseline to 6 weeks was measured using the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18), an 18-item self-report instrument assessing three domains of eating behavior. Cognitive Restraint (6 items; mean score range 1-4) reflects the conscious restriction of food intake to control body weight or promote weight loss. Uncontrolled Eating (9 items; mean score range 1-4) reflects a tendency to overeat due to loss of control over food intake and responsiveness to hunger or food cues. Emotional Eating (3 items; mean score range 1-4) reflects the tendency to eat in response to negative emotions such as stress, anxiety, or sadness. Higher scores indicate greater levels of the respective eating behavior.

  6 weeks

• Changes in Mindful Eating Behaviors

  Change in mindful eating behaviors from baseline to 6 weeks was measured using the Mindful Eating Behavior Scale (MEBS), a 17-item self-report instrument assessing four domains of mindful eating. Focused Eating (5 items; mean score range 1-4) assesses attention to sensory aspects of food and the eating experience. Hunger and Satiety Cues (5 items; mean score range 1-4) assess awareness of and responsiveness to internal hunger and fullness signals. Eating with Awareness (3 items; mean score range 1-4) assesses conscious awareness of eating behaviors. Eating without Distraction (4 items; mean score range 1-4) assesses the ability to eat without engaging in competing activities or thoughts. Higher scores indicate greater mindful eating within each domain. A total MEBS score is not computed.

  6 weeks

• Changes in Motivation

  Change in motivation for regulating eating behaviors from baseline to 6 weeks was measured using the Regulation of Eating Behaviors Scale (REBS), a 24-item self-report measure based on Self-Determination Theory. The REBS assesses six types of motivation: Intrinsic Motivation, Integrated Regulation, Identified Regulation, Introjected Regulation, External Regulation, and Amotivation. Items are rated on a 7-point scale. Autonomous motivation is calculated by summing Intrinsic, Integrated, and Identified Regulation subscales; controlled motivation is calculated by summing Introjected, External Regulation, and Amotivation subscales. Both scores range from 12 to 84, with higher scores indicating stronger motivation in the respective category. A self-determination score is calculated from weighted subscale scores, with higher values indicating greater autonomous motivation to regulate eating behaviors.

  6 weeks

Secondary Outcomes (13)

• Change in Blood Pressure

  Baseline to 6 weeks

• Change Body weight

  Baseline to 6 weeks

• Change in BMI

  6 weeks

• Change in Waist Circumference

  6 weeks

• Change in Hip-to-Waist Ratio

  6 weeks

Other Outcomes (6)

• Real-Time Eating Behaviors

  Throughout 6-week intervention

• EMA Engagement

  Throughout the 6 weeks

• Recruitment Rate

  At baseline

Study Arms (2)

DASH Diet with Mindful eating

EXPERIMENTAL

Participants in this arm will receive the Mind Your Heart program delivered via the e-Learning Commons (eLC) platform, consisting of six asynchronous modules completed over 6 weeks (20-30 minutes each).In addition to standard nutrition education, this arm includes mindful eating training that emphasizes awareness of hunger and satiety cues, eating pace, emotional triggers, and sensory aspects of food. Content integrates mindfulness-based strategies to improve self-regulation and eating behaviors. Participants will track dietary intake using MyFitnessPal and complete brief, repeated surveys assessing eating behaviors. No additional non-dietary intervention components are provided.

Behavioral: Mind Your Heart

DASH Diet education only

ACTIVE COMPARATOR

Participants in this arm will receive the Mind Your Heart nutrition education program delivered via the e-Learning Commons (eLC) platform. The intervention includes six asynchronous modules completed over 6 weeks (20-30 minutes each). Content emphasizes heart-healthy dietary patterns, including increasing fruit and vegetable intake, reducing saturated fat and added sugars, portion control, meal planning, and mindful eating. Behavior change techniques such as goal setting and self-monitoring are incorporated. Participants will track dietary intake using MyFitnessPal and complete brief surveys assessing eating behaviors throughout the intervention. No additional non-dietary intervention components are provided.

Behavioral: DASH Diet Education

Interventions

Mind Your Heart BEHAVIORAL

The Mind Your Heart intervention is a 6-week web-based behavioral program delivered through the e-Learning Commons (eLC) platform. The program consists of six structured modules integrating evidence-based DASH diet education with mindful eating training. Content focuses on awareness of hunger and satiety cues, sensory attention to food, and self-regulation of eating behaviors. Participants also complete dietary self-monitoring and ecological momentary assessment activities to support behavior change and reinforce program content.

DASH Diet with Mindful eating

DASH Diet Education BEHAVIORAL

The DASH Diet Education intervention is a 6-week web-based nutrition education program delivered through the e-Learning Commons (eLC) platform. The program consists of six structured modules focused on evidence-based DASH dietary recommendations and heart-healthy eating behaviors. Content includes dietary quality improvement, meal planning, portion control, label reading, and dietary self-monitoring to support behavior change.

DASH Diet education only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older
• Current University of Georgia (UGA) employees
• Able to provide informed consent
• Willing to complete online nutrition education modules over a 6-week period
• Willing to attend in-person study visits for baseline and follow-up assessments
• Willing to provide blood samples, blood pressure measurements, and complete eye exams
• Willing to complete online and mobile-based questionnaires
• Access to an internet-enabled device and a mobile phone for surveys and program

You may not qualify if:

• Unable to complete study procedures, including online modules or in-person visits
• Medical or other conditions that would preclude safe participation in study procedures (e.g., blood draw)
• Lack of access to required technology (internet or mobile phone) for participation

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30606, United States

Location

MeSH Terms

Conditions

Hypertension; Obesity; Overweight

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 26, 2026
• Study Start: January 20, 2022
• Primary Completion: April 15, 2022
• Study Completion: May 1, 2022
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: Access to de-identified individual participant data (IPD) will be granted to qualified researchers for scientific research purposes, including replication or secondary analyses consistent with the original study aims. Requests must include a brief research proposal outlining objectives, analytic plan, and data security procedures. Proposals will be reviewed by the study investigators to ensure scientific merit, feasibility, and protection of participant confidentiality. Approved users will be required to sign a data use agreement specifying conditions of use, data security requirements, and prohibition of re-identification. Requests and supporting documents should be submitted via email to the study investigators, and data will be shared using secure, institutionally approved transfer methods.

Locations

US (1)