A Workplace Intervention Trial Comparing Two Diabetes Prevention Programs - In-person and Online - Delivered in a Large Urban Workplace Environment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Body weight lost
研究概览
简要总结
This study evaluates two group-based Diabetes Prevention Program (DPP) lifestyle interventions delivered in the workplace to individuals at risk for pre-diabetes: 1) an in-person group-based lifestyle intervention; and 2) an internet-based intervention delivered using an online platform with lifestyle coaching support. Eligible participants will be randomized equally to each intervention program (120 participants in each).
详细描述
The study seeks to compare weight loss, changes in physical activity and dietary fat intake, and participant engagement in two Diabetes Prevention Program (DPP) interventions derived from the Centers for Disease Control and Prevention (CDC) curriculum: an in-person and an internet-based intervention program.
We hypothesize that the internet-based intervention will be more effective in achieving weight loss than the in-person intervention, given its convenience for participants to complete sessions and therefore greater potential engagement in the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ethnicity: All ethnic groups;
- •Sex: all genders;
- •Age (as of date of enrollment): Lower age limit: 18 years; Upper age limit: NONE;
- •Body mass index ≥ 25.0 kg/m2; ≥23 kg/m2 if Asian
- •Having pre-diabetes based on a score of 9+ on the CDC pre-diabetes screener
- •Able and willing to enroll and provide written, informed consent, i.e., to:
- •meet the time and data collection requirements of the study;
- •be randomized to one of the two intervention programs;
- •adhere to the recommendations of the study intervention as assigned; and
- •participate in follow-up for 12 months.
排除标准
- •Does not work at one of the participating employer work locations/departments;
- •Inability to speak, read, or understand English;
- •No regular access to a computer with internet capabilities;
- •Diagnosis of Type 1 or Type 2 diabetes mellitus;
- •Systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 100 mm Hg on more than one occasion during the last year;
- •Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe, such as exercise induced asthma or chronic obstructive pulmonary disease (COPD);
- •Use of weight-loss medications in the past 3 months;
- •Regular use (> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, oral hypoglycemics etc.);
- •Currently enrolled in a weight loss program;
- •Planning to undergo bariatric surgery during the study period;
- •Heart disease (angina, heart attack (myocardial infarction), congestive heart failure (CHF)), stroke;
- •Renal insufficiency;
- •Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years;
- •Pregnant, lactating or planning to become pregnant during the study period;
- •Already enrolled or planning to enroll in a research study that would limit full participation in this study or confound the observation and interpretation of the study's findings;
- •Planning to transfer to another department location during the study period;
- •Planning to move out of the area during the study period;
- •Investigator discretion for clinical safety or protocol adherence reasons.
研究组 & 干预措施
In-Person Diabetes Prevention Program
An in-person group delivery modality of a CDC recognized Diabetes Prevention Program (DPP), delivered by the Young Men's Christian Association (YMCA). This group receives lifestyle coaching in a group setting, meeting weekly for 16 weeks followed by 3 biweekly sessions, and 5 monthly maintenance sessions.
干预措施: In-Person Diabetes Prevention Program (Behavioral)
Online Diabetes Prevention Program
An online delivery modality of a CDC recognized Diabetes Prevention Program (DPP), delivered by Canary Health's Virtual Lifestyle Management program. This group completes online learning sessions weekly for 16 weeks followed by 8 monthly maintenance sessions.
干预措施: Online Diabetes Prevention Program (Behavioral)
结局指标
主要结局
Body weight lost
时间窗: 12 months
Percentage of body weight lost and the amount of weight lost (in pounds) on average over the 12 month follow-up, and at 6 and 12 months compared to baseline, by intervention arm. Body weight will be collected at baseline, 6 months, and 12 months.
次要结局
- Change in minutes of physical activity(12 months)
- Participant engagement(12 months)
- Change in dietary fat intake(12 months)
- Stress and well-being(12 months)