Puerto Rican Obesity Intervention for Men
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Acceptability- Satisfaction with Random Assignment to Groups
研究概览
简要总结
The goal of this clinical trial is to address the high rates of overweight/obesity in Puerto Rican (PR) men. The main question it aims to answer is whether virtual culturally relevant classes supporting physical activity and healthy eating for Puerto Rican men at different levels of acculturation to the US culture, will help these men achieve clinically meaningful weight loss.
The purpose of this project is to assess whether a virtual intervention tailored for Puerto Rican men that includes information about healthy eating, physical activity, sedentary behavior is feasible and acceptable compared to a general health (GH) intervention. It is also to determine whether this intervention leads to healthier eating, increased physical activity, less sedentary behavior (low activity), and clinically meaningful weight loss.
Hypothesis 1: Test the feasibility (recruitment, retention, adherence, fidelity) and acceptability (treatment components, intervention leaders, telehealth modality, technology and equipment, intervention satisfaction, satisfaction with randomized study, and measures) of a randomized 4-month synchronous telehealth lifestyle intervention led by a community health promoter and behavioral health specialist, who will receive either: TeleSalud HE-PA/SB" or TeleSalud GH in 48 PR men.
Hypothesis 2: Demonstrate proof -of-concept by achieving a clinically significant weight reduction of ≥ 5% of baseline weight in the TeleSalud HE-PA/SB intervention after 4 months and at the end of the 4-month maintenance compared to the TeleSalud General Health intervention.
Researchers will compare this to a group that will receive information about general health topics - not healthy eating or physical activity.
- Participants in both groups will meet via virtually for 4 months (twice per week for 3 months and once per week for 1 month).
- Participants will then meet one per month for a maintenance session for the next 4 months.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male of Puerto Rican descent over 35 years.
- •BMI ≥25 by anthropometrically measured weight and height.
- •Physically able to exercise (via the EASY tool [106, 107]; Appendix 2). If responses to the EASY indicate that medical clearance is needed, then able to receive medical clearance to participate in the study.
- •Has access to secure computer or tablet in a private location with reliable internet connection to support video streaming
- •Ability to understand and speak English. For those without a high-speed internet and private space to exercise, we will work with our community partners to identify a space with access to videoconferencing so they can attend the telehealth class.
排除标准
- •Does not understand/speak English.
- •Plans to move from the Illinois or Wisconsin area during the study.
- •Currently in a formal weight management program.
- •Current or planned use of weight control or loss medication prescribed by a doctor.
- •Currently exercising >1 time/week.
- •Unable to attend study times.
- •Serious medical problems or medications that would make protocol compliance difficult or dangerous, e.g., unable to engage in moderate & eventually vigorous exercise, uncontrolled diabetes (A1C > 9) or hypertension (systolic >160 or diastolic >100), hypoglycemia, heart attack in the past six months, unstable angina, life-threatening arrhythmias, cancer that required treatment in the last 5 years (except non-melanoma skin cancers that have been cured). Patients who have been treated for cancer in the past 5 years may require different diet and PA recommendations than individuals without treatment for cancer in the past 5 years.
- •In the EASY interview, if participant answers yes to the question that indicates they fall or always use an assisted device while walking.
- •Current alcohol abuse (>35 alcoholic drinks/week); score of yes to > 2 questions on the CAGE alcohol scale (Appendix 1) [108].
研究组 & 干预措施
Healthy Eating and Physical Activity - Intervention
Participants will attend virtual classes on increasing healthy eating, increasing physical activity, and decreasing sedentary behaviors.
干预措施: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) (Behavioral)
General Health Topics - Control
Participants will attend virtual classes on general health topics.
干预措施: TeleSalud General Health Intervention (Behavioral)
结局指标
主要结局
Acceptability- Satisfaction with Random Assignment to Groups
时间窗: Baseline, 4 months, 8 months
Acceptability- Assessed by a questionnaire assessing satisfaction with being in a study with random assignment to groups (14 questions, on a 5-point Likert scale: not at all satisfied to extremely satisfied).
Dietary Intake: Number of Servings of Fruits
时间窗: Baseline, 4 months, 8 months
Changes in number of servings of fruits will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool.
Feasibility- Adherence- Number of Make-Up Sessions
时间窗: 4 months, 8 months
Feasibility- Adherence- Number of Make-Up Sessions: Will be assessed by frequency/counts of number of make-up sessions.
Feasibility- Adherence- Weekly Attendance
时间窗: 4 months, 8 months
Feasibility- Adherence- Weekly Attendance: Will be measured by the frequency of attendance at each session on a weekly basis.
Feasibility- Recruitment- Number Enrolled
时间窗: Pre-Intervention
Recruitment feasibility assessed by the number of participants enrolled.
Feasibility- Retention- Percent Completed the Interventions
时间窗: 4 months, 8 months
Retention assessed by the percent of participants who completed the interventions.
Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment
时间窗: Baseline, 4 months, 8 months
Perceived helpfulness/ effectiveness of the telehealth modality, technology and equipment (3 questions, on 5-point Likert scale: not at all to extremely effective) will be assessed. The average of the telehealth components questions will be used as the overall dependent measure of the acceptability of the telehealth components.
Dietary Intake: Total Energy Intake
时间窗: Baseline, 4 months, 8 months
Changes in total energy intake will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
Feasibility- Recruitment- Recruitment Method
时间窗: Pre-Intervention
Feasibility assessed by tracking the method of recruitment.
Feasibility- Retention- Percent of Classes Attended
时间窗: 4 months, 8 months
Retention assessed by percent of classes attended.
Objective Physical Activity (Accelerometer)
时间窗: Baseline, 4 months, 8 months
A triaxial wrist accelerometer (ActiGraph wGT3XBT) will measure objective physical activity. They will used the accelerometer during waking hours for 7 days on their non-dominant wrist.
Subjective Sedentary Behavior (International Physical Activity Questionnaire)
时间窗: Baseline, 4 months, 8 months
The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.
Acceptability- Fidelity: Delivery
时间窗: 4 months, 8 months
Delivery will be measured by an adherence checklist. It will monitor consistency and accuracy in the delivery of the intervention.
Acceptability- Helpfulness/ Effectiveness of the Intervention Leaders
时间窗: 4 months, 8 months
Perceived helpfulness/ effectiveness of the intervention leaders (6 questions, on a 5-point Likert scale: not at alll to extremely helpful) will be assessed. The average of the questions will be used as the overall dependent measures of the acceptability of the intervention leaders.
Dietary Intake: Percent of Calories from Saturated Fat
时间窗: Baseline, 4 months, 8 months
Changes in percent of calories from saturated fat will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
Feasibility- Recruitment- Number Screened
时间窗: Pre-Intervention
Recruitment feasibility assessed by the count of number of individuals screened.
Feasibility- Recruitment- Number Consented
时间窗: Pre-Intervention
Recruitment feasibility assessed by the number of participants who consented.
Acceptability- Fidelity: Receipt
时间窗: 4 months, 8 months
Receipt will be measured by participants' self-reports of understanding and knowledge acquisition of content for both groups.
Acceptability- Fidelity: Enactment
时间窗: 4 months, 8 months
Enactment will be measured by participants' self-report of changes in behavior based on targets of treatment (e.g., Healthy Eating, Physical Activity, and Sedentary Behavior, General Health.)
Acceptability- Helpfulness of Treatment Components
时间窗: 4 months, 8 months
Perceived helpfulness/ effectiveness of various treatment components (12 questions, on a 5- point Likert scale: not at all to extremely effective) will be assessed. The average of the treatment component questions will be used as the overall dependent measure of the acceptability of the treatment components.
Acceptability- Intervention Satisfaction
时间窗: 4 months, 8 months
Acceptability- Assessed by an intervention satisfaction questionnaire (14 questions, on a 5- point Likert scale: not at all satisfied to extremely satisfied).
Dietary Intake: Number of Servings of Vegetables
时间窗: Baseline, 4 months, 8 months
Change in number of servings of vegetables will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool.
Feasibility- Adherence- Monthly Attendance
时间窗: 4 months, 8 months
Feasibility- Adherence- Monthly: Will be measured by the frequency of attendance at each session on a monthly basis.
Feasibility- Adherence- Number of Missed Sessions Overall
时间窗: 4 months, 8 months
Feasibility- Adherence- Number of Missed Sessions Overall: Will be assessed by frequency/ counts of the number of missed sessions overall (no make-up sessions).
Feasibility- Recruitment- Rate of Consenting
时间窗: Pre-Intervention
Recruitment feasibility assessed by the rate of consenting.
Feasibility- Recruitment- Rate of Screening
时间窗: Pre-Intervention
Recruitment feasibility assessed by the rate of screening.
Feasibility- Recruitment- Response Rate
时间窗: Pre-Intervention
Recruitment feasibility assessed by rate of response.
Feasibility- Retention- Number Completed the intervention
时间窗: 4 months, 8 months
Retention assessed by counts and frequency of the number who completed the interventions.
Feasibility- Retention- Number of Classes Attended
时间窗: 4 months, 8 months
Retention- assessed by counts of the number of classes attended.
Feasibility- Recruitment- Number of Contacts
时间窗: Pre-Intervention
Recruitment feasibility assessed by counts of the number of contacts.
Feasibility- Recruitment- Rate of Enrollment
时间窗: Pre-Intervention
Recruitment feasibility assessed by the rate of enrollment.
Feasibility- Recruitment- Type of Contact
时间窗: Pre-Intervention
Recruitment feasibility assessed by tracking the type of contact.
Subjective Physical Activity (International Physical Activity Questionnaire)
时间窗: Baseline, 4 months, 8 months
The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.
次要结局
- Body Mass Index(Baseline, 4 months, 8 months)
- Outcome Expectations for Diet Questionnaire(Baseline, 4 months, 8 months)
- Exercise Outcomes on the Outcomes Expectations Questionnaire(Baseline, 4 months, 8 months)
- Exercise Confidence Survey(Baseline, 4 months, 8 months)
- Self-Efficacy for Dietary Behaviors(Baseline, 4 months, 8 months)
- Social Support and Eating Habits Survey(Baseline, 4 months, 8 months)
- Social Support and Exercise Survey(Baseline, 4 months, 8 months)
研究者
Lisa Sanchez-Johnsen
Professor
Medical College of Wisconsin