Intervention Effects on Health Promoting Behaviors and Factors Influencing Long-Term Behavior Change
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Eating Behavior Inventory (EBI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Statistician
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65
- •BMI between 25.00 and 40.00
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: An 8-week virtual group intervention designed to promote sustainable health behavior changes in participants (Behavioral)
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.
干预措施: Standard of care Nutritional Information (Behavioral)
结局指标
主要结局
Eating Behavior Inventory (EBI)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Total cholesterol(Baseline, 8 weeks and 3 months post intervention.)
- Body fat%(Baseline, 8 weeks and 3 months post intervention.)
- Lean Body Mass(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.)
- Brachial Blood Pressure(Baseline, 8 weeks and 3 months post intervention.)
- Aortic Blood Pressure(Baseline, 8 weeks and 3 months post intervention.)
- Body Weight(Baseline, 8 weeks and 3 months post intervention.)
- Relationships Between Health Behaviors and Biomarkers/Body Composition(8 weeks and 3 months post intervention.)
- Self Efficacy(Baseline, 8 weeks and 3 months post intervention.)
- Social Support(Baseline, 8 weeks and 3 months post intervention.)
- Sleep quality(Baseline, 8 weeks and 3 months post intervention.)