Intervention Effects on Health Promoting Behaviors and Factors Influencing Long-Term Behavior Change (HYP)

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 Overview

• Status: Active, not recruiting
• Conditions: Obese Patients; Overweight (BMI > 25)
• Intervention / Treatment: Behavioral: An 8-week virtual group intervention designed to promote sustainable health behavior changes in participants; Behavioral: Standard of care Nutritional Information

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Food and Nutrition Clinical Research Lab, Colorado State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18-65
• BMI between 25.00 and 40.00

Exclusion Criteria:

• Pregnancy or lactation
• Existing or previous eating disorders
• Use of a medically prescribed diet
• Weight loss or gain of 3 kg or more in the past 3 months
• Use of medications or supplements for weight or chronic disease management (withing the last 3 months)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy YOU Virtual behavioral Intervention; An interactive, virtual intervention in a group setting focusing on adapting behaviors to sustain healthy improvements in dietary intake and physical activity.	Behavioral: An 8-week virtual group intervention designed to promote sustainable health behavior changes in participants; 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.
Active Comparator: Standard of Care Weight management intervention; An 8 week standard of care intervention consisting of informational flyers that can be implemented in a self paced manner.	Behavioral: Standard of care Nutritional Information; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating 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.	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.	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.	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.	3 months post conclusion of intervention program.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol	Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.	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.	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.	Baseline, 8 weeks and 3 months post intervention.
Triglycerides	Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.	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.	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.	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.	Baseline, 8 weeks and 3 months post intervention.
Body Weight	Measured using a standard stadiometer.	Baseline, 8 weeks and 3 months post intervention.
Body fat%	Measured using Dual-Energy X-ray Absorptiometry (DEXA)	Baseline, 8 weeks and 3 months post intervention.
Lean Body Mass	Measured using Dual-Energy X-ray Absorptiometry (DEXA).	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).	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.	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).	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.	Baseline, 8 weeks and 3 months post intervention.

Collaborators and Investigators

• Sponsor: Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Actual): January 31, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: sustainable health behaviors; virtual healthy eating program; eating behavior intervention
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight
• Other Study ID Numbers: 6510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No