Puerto Rican Obesity Intervention for Men
This study is for Puerto Rican men over 35 who are overweight or obese (BMI of 25 or higher). It aims to see if virtual classes, called TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB), can help with weight loss. These classes focus on healthy eating and physical activity. The study will compare these classes to a TeleSalud General Health Intervention. We want to find out if the HE-PA/SB classes are practical and well-received. The study is currently unclear on its recruitment status and plans to enroll 48 participants.
- Study design
- This interventional study plans to enroll 48 men. It compares two different virtual health interventions.
- What's involved
- Participants will meet via telehealth for 4 months (twice a week for 3 months, then once a week for 1 month), followed by one maintenance meeting per month for 4 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes at 4 months and 8 months.
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Puerto Rican Obesity Intervention for Men
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Lisa Sanchez-Johnsen, PhD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Who to contact
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What this trial measures
- Acceptability- Fidelity: Delivery4 months, 8 months
Delivery will be measured by an adherence checklist. It will monitor consistency and accuracy in the delivery of the intervention.
- Acceptability- Fidelity: Receipt4 months, 8 months
Receipt will be measured by participants' self-reports of understanding and knowledge acquisition of content for both groups.
- Acceptability- Fidelity: Enactment4 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 Components4 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- Helpfulness/ Effectiveness of the Intervention Leaders4 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.
- Acceptability- Intervention Satisfaction4 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).
- Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and EquipmentBaseline, 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.
- Acceptability- Satisfaction with Random Assignment to GroupsBaseline, 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 FruitsBaseline, 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.
- Dietary Intake: Number of Servings of VegetablesBaseline, 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.
- Dietary Intake: Percent of Calories from Saturated FatBaseline, 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.
- Dietary Intake: Total Energy IntakeBaseline, 4 months, 8 months
Changes in total energy intake will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
- Feasibility- Adherence- Monthly Attendance4 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 Make-Up Sessions4 months, 8 months
Feasibility- Adherence- Number of Make-Up Sessions: Will be assessed by frequency/counts of number of make-up sessions.
- Feasibility- Adherence- Number of Missed Sessions Overall4 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- Adherence- Weekly Attendance4 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 EnrolledPre-Intervention
Recruitment feasibility assessed by the number of participants enrolled.
- Feasibility- Recruitment- Number of ContactsPre-Intervention
Recruitment feasibility assessed by counts of the number of contacts.
- Feasibility- Recruitment- Rate of ConsentingPre-Intervention
Recruitment feasibility assessed by the rate of consenting.
- Feasibility- Recruitment- Rate of EnrollmentPre-Intervention
Recruitment feasibility assessed by the rate of enrollment.
- Feasibility- Recruitment- Rate of ScreeningPre-Intervention
Recruitment feasibility assessed by the rate of screening.
- Feasibility- Recruitment- Recruitment MethodPre-Intervention
Feasibility assessed by tracking the method of recruitment.
- Feasibility- Recruitment- Response RatePre-Intervention
Recruitment feasibility assessed by rate of response.
- Feasibility- Recruitment- Type of ContactPre-Intervention
Recruitment feasibility assessed by tracking the type of contact.
- Feasibility- Retention- Number Completed the intervention4 months, 8 months
Retention assessed by counts and frequency of the number who completed the interventions.
- Feasibility- Recruitment- Number ScreenedPre-Intervention
Recruitment feasibility assessed by the count of number of individuals screened.
- Feasibility- Retention- Number of Classes Attended4 months, 8 months
Retention- assessed by counts of the number of classes attended.
- Feasibility- Retention- Percent Completed the Interventions4 months, 8 months
Retention assessed by the percent of participants who completed the interventions.
- Feasibility- Retention- Percent of Classes Attended4 months, 8 months
Retention assessed by percent of classes attended.
- Feasibility- Recruitment- Number ConsentedPre-Intervention
Recruitment feasibility assessed by the number of participants who consented.
- Objective Physical Activity (Accelerometer)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 Physical Activity (International Physical Activity Questionnaire)Baseline, 4 months, 8 months
The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.
- Subjective Sedentary Behavior (International Physical Activity Questionnaire)Baseline, 4 months, 8 months
The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.