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

Not Applicable

Recruiting

• Conditions: Overweight (BMI > 25); Obese Patients

• Registration Number: NCT06892587
• Lead Sponsor: Colorado State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-25
• Study Start: 2025-05-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-06
• Primary Completion: 2026-01
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eating Behavior Inventory (EBI)	Baseline, 8 weeks and 3 months post intervention.	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.
Dietary Intake Patterns	Baseline, 8 weeks and 3 months post intervention.	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.
Physical Activity Levels	Baseline, 8 weeks and 3 months post intervention.	Physical Activity levels measured by GODIN Physical Activity Assessment. Increases in frequency, time, type, and intensity of exercise would be associated with better outcomes.
Sustained Healthy Behaviors	3 months post conclusion of intervention program.	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.

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	Baseline, 8 weeks and 3 months post intervention.	Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
LDL Cholesterol	Baseline, 8 weeks and 3 months post intervention.	Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
HDL Cholesterol	Baseline, 8 weeks and 3 months post intervention.	Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Triglycerides	Baseline, 8 weeks and 3 months post intervention.	Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
HemoglobinA 1c (HbA1c): Average blood sugar levels over 2-3 months.	Baseline, 8 weeks and 3 months post intervention.	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.
Brachial Blood Pressure	Baseline, 8 weeks and 3 months post intervention.	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.
Aortic Blood Pressure	Baseline, 8 weeks and 3 months post intervention.	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.
Body Weight	Baseline, 8 weeks and 3 months post intervention.	Measured using a standard stadiometer.
Body fat%	Baseline, 8 weeks and 3 months post intervention.	Measured using Dual-Energy X-ray Absorptiometry (DEXA)
Lean Body Mass	Baseline, 8 weeks and 3 months post intervention.	Measured using Dual-Energy X-ray Absorptiometry (DEXA).
Relationships Between Health Behaviors and Biomarkers/Body Composition	8 weeks and 3 months post intervention.	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).
Self Efficacy	Baseline, 8 weeks and 3 months post intervention.	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.
Social Support	Baseline, 8 weeks and 3 months post intervention.	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).
Sleep quality	Baseline, 8 weeks and 3 months post intervention.	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.

Trial Locations

Locations (1)

Food and Nutrition Clinical Research Lab, Colorado State University; 🇺🇸 Fort Collins, Colorado, United States