Clinical trial NCT06892587: Intervention Effects on Health Promoting Behaviors and Factors Influencing Long-Term Behavior Change
Official title: Intervention Effects on Health Promoting Behaviors and Factors Influencing Long-Term Behavior Change
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight (BMI &gt; 25)
Obese Patients
Keywords: sustainable health behaviors
virtual healthy eating program
eating behavior intervention
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded randomized controlled trial, pilot study.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Eating Behavior Inventory (EBI)
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Dietary Intake Patterns
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Physical Activity Levels
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Sustained Healthy Behaviors
timeFrame: 3 months post conclusion of intervention program.
Secondary outcomes:
measure: Total cholesterol
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: LDL Cholesterol
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: HDL Cholesterol
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Triglycerides
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: HemoglobinA 1c (HbA1c): Average blood sugar levels over 2-3 months.
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Brachial Blood Pressure
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Aortic Blood Pressure
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Body Weight
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Body fat%
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Lean Body Mass
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Relationships Between Health Behaviors and Biomarkers/Body Composition
timeFrame: 8 weeks and 3 months post intervention.
measure: Self Efficacy
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Social Support
timeFrame: Baseline, 8 weeks and 3 months post intervention.
measure: Sleep quality
timeFrame: Baseline, 8 weeks and 3 months post intervention.
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Food and Nutrition Clinical Research Lab, Colorado State University
state: Colorado
Study officials:
References: