Overweight (BMI > 25)HYPNCT06892587
Intervention Effects on Health Promoting Behaviors and Factors Influencing Long-Term Behavior Change
A study testing An 8-week virtual group intervention designed to promote sustainable health behavior changes in participants in people with Overweight (BMI > 25) and Obese Patients, run by Colorado State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight (BMI > 25), Obese Patients
- What is being tested?
- An 8-week virtual group intervention designed to promote sustainable health behavior changes in participants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65
- BMI between 25.00 and 40.00
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Food and Nutrition Clinical Research Lab, Colorado State University
Fort Collins, Colorado, 80523
About this study
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
- Being tested
- An 8-week virtual group intervention designed to promote sustainable health behavior changes in participants, Standard of care Nutritional Information
- Keywords
- sustainable health behaviors, virtual healthy eating program, eating behavior intervention
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An 8-week virtual group intervention designed to promote sustainable health behavior changes in participantsBehavioural
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 Nutritional InformationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of care Nutritional Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months post conclusion of intervention program.
Secondary outcomes (14)
Total cholesterol
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks and 3 months post intervention.
Triglycerides
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks and 3 months post intervention.
Body Weight
Measured using a standard stadiometer.
Measured: Baseline, 8 weeks and 3 months post intervention.
Body fat%
Measured using Dual-Energy X-ray Absorptiometry (DEXA)
Measured: Baseline, 8 weeks and 3 months post intervention.
Lean Body Mass
Measured using Dual-Energy X-ray Absorptiometry (DEXA).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 8 weeks and 3 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start20 May 2025
- Primary completion31 Jan 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomized controlled trial, pilot study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892587
- Sponsor's protocol ID
- 6510
- Acronym
- HYP
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effects on Health Promoting Behaviors and Factors Influencing Long-Term Behavior Change
- ClinicalTrials.gov ID
- NCT06892587
- Acronym / sponsor ID
- HYP / 6510
- Conditions
- Overweight (BMI > 25), Obese Patients
- Keywords
- sustainable health behaviors, virtual healthy eating program, eating behavior intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded randomized controlled trial, pilot study.
| Arm | Type | Receives |
|---|---|---|
| Healthy YOU Virtual behavioral Intervention | Experimental | Behavioral: An 8-week virtual group intervention designed to promote sustainable health behavior changes in participantsAn interactive, virtual intervention in a group setting focusing on adapting behaviors to sustain healthy improvements in dietary intake and physical activity. |
| Standard of Care Weight management intervention | Active comparator | Behavioral: Standard of care Nutritional InformationAn 8 week standard of care intervention consisting of informational flyers that can be implemented in a self paced manner. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18-65
- BMI between 25.00 and 40.00
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An 8-week virtual group intervention designed to promote sustainable health behavior changes in participantsThe 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. | Behavioural | Healthy YOU Virtual behavioral Intervention |
| Standard of care Nutritional InformationThe 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. | Behavioural | Standard of Care Weight management intervention |
Primary outcome
Eating Behavior Inventory (EBI)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
14 secondary outcomes
Total cholesterol
Time frame: Baseline, 8 weeks and 3 months post intervention.
LDL Cholesterol
Time frame: Baseline, 8 weeks and 3 months post intervention.
HDL Cholesterol
Time frame: Baseline, 8 weeks and 3 months post intervention.
Triglycerides
Time frame: Baseline, 8 weeks and 3 months post intervention.
HemoglobinA 1c (HbA1c): Average blood sugar levels over 2-3 months.
Time frame: Baseline, 8 weeks and 3 months post intervention.
Brachial Blood Pressure
Time frame: Baseline, 8 weeks and 3 months post intervention.
Aortic Blood Pressure
Time frame: Baseline, 8 weeks and 3 months post intervention.
Body Weight
Time frame: Baseline, 8 weeks and 3 months post intervention.
Body fat%
Time frame: Baseline, 8 weeks and 3 months post intervention.
Lean Body Mass
Time frame: Baseline, 8 weeks and 3 months post intervention.
Relationships Between Health Behaviors and Biomarkers/Body Composition
Time frame: 8 weeks and 3 months post intervention.
Self Efficacy
Time frame: Baseline, 8 weeks and 3 months post intervention.
Social Support
Time frame: Baseline, 8 weeks and 3 months post intervention.
Sleep quality
Time frame: Baseline, 8 weeks and 3 months post intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An 8-week virtual group intervention designed to promote sustainable health behavior changes in participants in people with Overweight (BMI > 25) and Obese Patients, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Behavior Inventory (EBI) (time frame: Baseline, 8 weeks and 3 months post intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.