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

Purpose

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

  • Overweight (BMI > 25)
  • Obese Patients

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Single blinded randomized controlled trial, pilot study.
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Statistician

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Food and Nutrition Clinical Research Lab, Colorado State University
Fort Collins, Colorado 80523
Contact:
Jenny Whittington, MS
970-310-6843
ijwhitt@rams.colostate.edu

More Details

NCT ID
NCT06892587
Status
Recruiting
Sponsor
Colorado State University

Study Contact

Dr. Sarah Johnson, PhD
970-491-3807
sarah.johnson@colostate.edu

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center