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

NCT ID: NCT06892587

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight (BMI > 25) Obese Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blinded randomized controlled trial, pilot study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Statistician

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Standard of care Nutritional Information

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Colorado State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Food and Nutrition Clinical Research Lab, Colorado State University

Fort Collins, Colorado, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr. Sarah Johnson, PhD

Role: CONTACT

970-491-3807

Jenny Whittington, MS

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jenny Whittington, MS

Role: primary

970-310-6843

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6510

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Weight Loss Through Mayo Clinic Diet
NCT06862375 RECRUITING NA
Physical Activity Choices Everyday
NCT03824769 COMPLETED NA