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

NCT06892587 | Active Not Recruiting

• 1 other identifier: 6510
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Patients; Overweight (BMI > 25)

Keywords

sustainable health behaviors; virtual healthy eating program; eating behavior intervention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Total cholesterol

  Baseline, 8 weeks and 3 months post intervention.

• LDL Cholesterol

  Baseline, 8 weeks and 3 months post intervention.

• HDL Cholesterol

  Baseline, 8 weeks and 3 months post intervention.

• Triglycerides

  Baseline, 8 weeks and 3 months post intervention.

• HemoglobinA 1c (HbA1c): Average blood sugar levels over 2-3 months.

  Baseline, 8 weeks and 3 months post intervention.

Study Arms (2)

Healthy YOU Virtual behavioral Intervention

EXPERIMENTAL

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

Standard of Care Weight management intervention

ACTIVE COMPARATOR

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

Interventions

Standard of care Nutritional Information BEHAVIORAL

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.

Standard of Care Weight management intervention

An 8-week virtual group intervention designed to promote sustainable health behavior changes in participants BEHAVIORAL

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.

Healthy YOU Virtual behavioral Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Food and Nutrition Clinical Research Lab, Colorado State University

Fort Collins, Colorado, 80523, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded randomized controlled trial, pilot study.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: May 20, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)