This study aims to compare the 8-week virtual Healthy YOU Program with a standard care intervention that sends weekly nutrition and healthy living tips via email. It will evaluate short- and long-term changes in health behaviors, such as diet, physical activity, biomarkers, and body composition. The study also seeks to identify factors that help participants make lasting health changes and explore how lifestyle interventions can improve overall health. Findings may guide future programs and support non-weight-focused approaches to chronic disease management and healthcare policy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
The Healthy YOU Program is an 8-week virtual group intervention designed to help participants make lasting health behavior changes, focusing on diet and physical activity. Delivered via confidential Zoom sessions, it offers flexibility and support in a group setting. Participants engage in facilitated discussions, interactive activities, and expert guidance. Participants receive a structured curriculum with a printed workbook, covering evidence-based topics like nutrition, exercise, and well-being. Learning methods include: Weekly Newsletters: Provide health tips, resources, and reflections to support behavior change. Facilitated Group Discussions: Live sessions to share experiences, ask questions, and support each other. Applied Activities: Hands-on tasks like meal planning and goal-setting to build confidence. Demonstrations: Live sessions on healthy cooking, home exercises, and overcoming barriers. The program encourages goal setting, progress tracking, and self-regulation.
The standard of care will involve providing participants with 8 weeks of nutrition information through printed handouts. These handouts will be generic, similar to materials typically provided by healthcare providers or available on public-facing health/nutrition websites. While they will cover the same topics as the experimental group, the handouts will contain only basic, publicly available nutritional information and will not include guidance for application. These handouts are also included in the Healthy YOU curriculum as background material for weekly class preparation. Participants will be instructed to review and utilize the handout information in a self-paced manner over the 8-week period.
Food and Nutrition Clinical Research Lab, Colorado State University
Fort Collins, Colorado, United States
RECRUITINGEating Behavior Inventory (EBI)
The Eating Behavior Inventory (EBI) measures behaviors that help with weight management. It includes 26 items based on a survey of behavior treatment manuals, and focuses on behaviors linked to weight loss. Each item is rated on a 5-point scale, from "never" to "always." The EBI looks at both healthy behaviors (e.g., "I carefully watch the quantity of food I eat") and unhealthy behaviors (e.g., "I eat quickly compared to most people"). Negative behaviors are scored in reverse, so higher scores on the EBI indicate more behaviors that support weight loss. Scores range from 26 to 130.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Dietary Intake Patterns
The ASA-24 Dietary Assessment Tool will be used to document foods and supplements consumed over a 3 day period (2 weekdays and a weekend day). Changes in sugar, sodium, and fat intake will be measured (with lower amounts indicating better outcomes) as well as changes in fruit and vegetable intake, fiber intake, and Healthy Eating Index score where higher amounts indicating better outcomes.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Physical Activity Levels
Physical Activity levels measured by GODIN Physical Activity Assessment. Increases in frequency, time, type, and intensity of exercise would be associated with better outcomes.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Sustained Healthy Behaviors
One or more diet or physical activity behaviors associated with a "better outcome" as measured by the ASA24 diet recall or the GODIN Physical Activity Assessment remains the same or better at the 3 month follow up mark as compared to baseline and post treatment visits.
Time frame: 3 months post conclusion of intervention program.
Total cholesterol
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Time frame: Baseline, 8 weeks and 3 months post intervention.
LDL Cholesterol
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Time frame: Baseline, 8 weeks and 3 months post intervention.
HDL Cholesterol
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Triglycerides
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Time frame: Baseline, 8 weeks and 3 months post intervention.
HemoglobinA 1c (HbA1c): Average blood sugar levels over 2-3 months.
Measured with a point of care instrument that is a fully automated boronate affinity assay to determine the percentage of hemoglobin A1c in human whole blood.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Brachial Blood Pressure
Measured with a point of care device that measures central (aortic) blood pressure and brachial blood pressure. It is based on a method called arterial tonometry.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Aortic Blood Pressure
Measured with a point of care device that measures central (aortic) blood pressure and brachial blood pressure. It is based on a method called arterial tonometry.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Body Weight
Measured using a standard stadiometer.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Body fat%
Measured using Dual-Energy X-ray Absorptiometry (DEXA)
Time frame: Baseline, 8 weeks and 3 months post intervention.
Lean Body Mass
Measured using Dual-Energy X-ray Absorptiometry (DEXA).
Time frame: Baseline, 8 weeks and 3 months post intervention.
Relationships Between Health Behaviors and Biomarkers/Body Composition
We'll assess any correlations between changes in health behaviors (dietary intake and physical activity) and improvements in biomarkers (e.g., cholesterol, blood pressure) and body composition (e.g., body fat percentage, muscle mass).
Time frame: 8 weeks and 3 months post intervention.
Self Efficacy
A 10 item survey that assesses a person's overall self-confidence in their capacity to handle and overcome obstacles, perform tasks, and manage stress in different areas of life. Higher scores are associated with better outcomes.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Social Support
A survey which measures how much support an individual feels they receive from their social network, including family, friends, and significant others. The scale evaluates the individual's perception of the availability, adequacy, and quality of social support in times of need. Higher scores are associated with better outcomes (higher social support).
Time frame: Baseline, 8 weeks and 3 months post intervention.
Sleep quality
Measured with the Pittsburgh Sleep Quality Index (PSQI). This survey contains 19 self-rated questions (items), and the responses are used to generate a total score. These items are divided into 7 components, each evaluating a different aspect of sleep quality. A total score of less than 5 suggests good sleep quality, with minimal sleep problems or disturbances. A total score of 5 or higher typically indicates poor sleep quality.
Time frame: Baseline, 8 weeks and 3 months post intervention.
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