ObesityNCT06440551
Puerto Rican Obesity Intervention for Men
A study testing TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) and TeleSalud General Health Intervention in people with Obesity, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) and TeleSalud General Health Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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].
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Lisa Sanchez-Johnsen, PhD, lsanchezjohnsen@mcw.edu
About this study
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB), TeleSalud General Health Intervention
- Keywords
- Diet, Physical Activity, Puerto Rican
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)Behavioural
Participants will meet via telehealth for 4 months (twice a week for 3 months and then once per week for 1 month) for a TeleSalud HE-PA/SB Class, after which they will attend one maintenance meeting per month for 4 months. Weekly, Day 1 (Healthy Eating \& PA-SB Class): Participants will receive a 50-min. healthy eating class. Physical Activity- Sedentary Behavior (PA-SB) Class: By discussing barriers and strategies to overcome barriers, this will help to increase self-efficacy. We will engage in Latino-centered moderate impact (increasing to vigorous) aerobics with Latino or salsa movements and music for 45-50 minutes. Aspects of kickboxing aerobics will be integrated. Goal: Exercise a minimum of 150-250 min./ week of moderate intensity. Weekly, Day 2: PA-SB identical PA-SB to Day 1. Maintenance (Months 5-8): Meetings once/ month for 70 min. for HE/PA-SB class, including 25 min. to discuss diet and PA-SB barriers. Goal: Exercise a minimum of 150-250 min./week.
TeleSalud General Health InterventionBehavioural
Weekly: Participants will meet via telehealth for 4 months (twice a week for 3 months and then once per week for 1 month) for a TeleSalud General Heath Class, after which they will attend one maintenance meeting per month for 4 months. Participants will meet and discuss general health topics (not diet or PA). Examples of the general health topics are: Back Pain, Muscle Strains, Alcohol Use, Stress \& Coping, Oral and Dental Health, Safety Tips, Emergency Preparedness. The content is relevant to Latinos, and information is focused on Latino men. Maintenance (Months 5-8): Participants will meet via telehealth once/ month for 70 min. to discuss general health topics. To enhance motivation to complete the study and assessments, this group will receive a copy of the TeleSalud HE-PA/SB intervention manual and related materials after the maintenance period ends.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Eating and Physical Activity - Intervention | Experimental | Participants will attend virtual classes on increasing healthy eating, increasing physical activity, and decreasing sedentary behaviors. Receives: Behavioral: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) |
| General Health Topics - Control | Active comparator | Participants will attend virtual classes on general health topics. Receives: Behavioral: TeleSalud General Health Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability- Fidelity: Delivery
Delivery will be measured by an adherence checklist. It will monitor consistency and accuracy in the delivery of the intervention.
Measured: 4 months, 8 months
Acceptability- Fidelity: Receipt
Receipt will be measured by participants' self-reports of understanding and knowledge acquisition of content for both groups.
Measured: 4 months, 8 months
Acceptability- Fidelity: Enactment
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.)
Measured: 4 months, 8 months
Acceptability- Helpfulness of Treatment Components
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.
Measured: 4 months, 8 months
Acceptability- Helpfulness/ Effectiveness of the Intervention Leaders
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.
Measured: 4 months, 8 months
Acceptability- Intervention Satisfaction
Acceptability- Assessed by an intervention satisfaction questionnaire (14 questions, on a 5- point Likert scale: not at all satisfied to extremely satisfied).
Measured: 4 months, 8 months
Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment
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.
Measured: Baseline, 4 months, 8 months
Acceptability- Satisfaction with Random Assignment to Groups
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).
Measured: Baseline, 4 months, 8 months
Dietary Intake: Number of Servings of Fruits
Changes in number of servings of fruits will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool.
Measured: Baseline, 4 months, 8 months
Dietary Intake: Number of Servings of Vegetables
Change in number of servings of vegetables will be measured by the Automated Self-Administered 24- Hour (ASA24) Dietary Assessment Tool.
Measured: Baseline, 4 months, 8 months
Dietary Intake: Percent of Calories from Saturated Fat
Changes in percent of calories from saturated fat will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
Measured: Baseline, 4 months, 8 months
Dietary Intake: Total Energy Intake
Changes in total energy intake will be measured by the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool.
Measured: Baseline, 4 months, 8 months
Feasibility- Adherence- Monthly Attendance
Feasibility- Adherence- Monthly: Will be measured by the frequency of attendance at each session on a monthly basis.
Measured: 4 months, 8 months
Feasibility- Adherence- Number of Make-Up Sessions
Feasibility- Adherence- Number of Make-Up Sessions: Will be assessed by frequency/counts of number of make-up sessions.
Measured: 4 months, 8 months
Feasibility- Adherence- Number of Missed Sessions Overall
Feasibility- Adherence- Number of Missed Sessions Overall: Will be assessed by frequency/ counts of the number of missed sessions overall (no make-up sessions).
Measured: 4 months, 8 months
Feasibility- Adherence- Weekly Attendance
Feasibility- Adherence- Weekly Attendance: Will be measured by the frequency of attendance at each session on a weekly basis.
Measured: 4 months, 8 months
Feasibility- Recruitment- Number Enrolled
Recruitment feasibility assessed by the number of participants enrolled.
Measured: Pre-Intervention
Feasibility- Recruitment- Number of Contacts
Recruitment feasibility assessed by counts of the number of contacts.
Measured: Pre-Intervention
Feasibility- Recruitment- Rate of Consenting
Recruitment feasibility assessed by the rate of consenting.
Measured: Pre-Intervention
Feasibility- Recruitment- Rate of Enrollment
Recruitment feasibility assessed by the rate of enrollment.
Measured: Pre-Intervention
Feasibility- Recruitment- Rate of Screening
Recruitment feasibility assessed by the rate of screening.
Measured: Pre-Intervention
Feasibility- Recruitment- Recruitment Method
Feasibility assessed by tracking the method of recruitment.
Measured: Pre-Intervention
Feasibility- Recruitment- Response Rate
Recruitment feasibility assessed by rate of response.
Measured: Pre-Intervention
Feasibility- Recruitment- Type of Contact
Recruitment feasibility assessed by tracking the type of contact.
Measured: Pre-Intervention
Feasibility- Retention- Number Completed the intervention
Retention assessed by counts and frequency of the number who completed the interventions.
Measured: 4 months, 8 months
Feasibility- Recruitment- Number Screened
Recruitment feasibility assessed by the count of number of individuals screened.
Measured: Pre-Intervention
Feasibility- Retention- Number of Classes Attended
Retention- assessed by counts of the number of classes attended.
Measured: 4 months, 8 months
Feasibility- Retention- Percent Completed the Interventions
Retention assessed by the percent of participants who completed the interventions.
Measured: 4 months, 8 months
Feasibility- Retention- Percent of Classes Attended
Retention assessed by percent of classes attended.
Measured: 4 months, 8 months
Feasibility- Recruitment- Number Consented
Recruitment feasibility assessed by the number of participants who consented.
Measured: Pre-Intervention
Objective Physical Activity (Accelerometer)
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.
Measured: Baseline, 4 months, 8 months
Subjective Physical Activity (International Physical Activity Questionnaire)
The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.
Measured: Baseline, 4 months, 8 months
Subjective Sedentary Behavior (International Physical Activity Questionnaire)
The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.
Measured: Baseline, 4 months, 8 months
Secondary outcomes (7)
Body Mass Index
Body Mass Index (BMI) will be assessed by objectively measured height and weight.
Measured: Baseline, 4 months, 8 months
Outcome Expectations for Diet Questionnaire
Outcome expectations will be assessed by the Outcome Expectations for Diet Questionnaire. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.
Measured: Baseline, 4 months, 8 months
Exercise Outcomes on the Outcomes Expectations Questionnaire
Outcome expectations for Exercise will be assessed by the Exercise Outcomes on the Outcomes Expectations Questionnaire. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.
Measured: Baseline, 4 months, 8 months
Self-Efficacy for Dietary Behaviors
Self-efficacy will be assessed by the Self-Efficacy for Dietary Behaviors. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.
Measured: Baseline, 4 months, 8 months
Exercise Confidence Survey
Self-efficacy will be assessed by the Exercise Confidence Survey. This measure will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.
Measured: Baseline, 4 months, 8 months
Social Support and Eating Habits Survey
Social Support will be assessed by the Social Support and Exercise Survey and the Social Support and Eating Habits Survey. These measures will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.
Measured: Baseline, 4 months, 8 months
Social Support and Exercise Survey
Social Support will be assessed by the Social Support and Exercise Survey and the Social Support and Eating Habits Survey. These measures will be used to assess the various components of Social Cognitive Theory which are guiding the TeleSalud HE-PA/SB intervention.
Measured: Baseline, 4 months, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Mar 2027 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Sanchez-Johnsen, Medical College of Wisconsin
- Investigators
- Lisa Sanchez-Johnsen, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440551
- Sponsor's protocol ID
- 0048231
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puerto Rican Obesity Intervention for Men
- ClinicalTrials.gov ID
- NCT06440551
- Acronym / sponsor ID
- 0048231
- Conditions
- Obesity
- Keywords
- Diet, Physical Activity, Puerto Rican
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Eating and Physical Activity - Intervention | Experimental | Behavioral: TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)Participants will attend virtual classes on increasing healthy eating, increasing physical activity, and decreasing sedentary behaviors. |
| General Health Topics - Control | Active comparator | Behavioral: TeleSalud General Health InterventionParticipants will attend virtual classes on general health topics. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB)Participants will meet via telehealth for 4 months (twice a week for 3 months and then once per week for 1 month) for a TeleSalud HE-PA/SB Class, after which they will attend one maintenance meeting per month for 4 months. Weekly, Day 1 (Healthy Eating \& PA-SB Class): Participants will receive a 50-min. healthy eating class. Physical Activity- Sedentary Behavior (PA-SB) Class: By discussing barriers and strategies to overcome barriers, this will help to increase self-efficacy. We will engage in Latino-centered moderate impact (increasing to vigorous) aerobics with Latino or salsa movements and music for 45-50 minutes. Aspects of kickboxing aerobics will be integrated. Goal: Exercise a minimum of 150-250 min./ week of moderate intensity. Weekly, Day 2: PA-SB identical PA-SB to Day 1. Maintenance (Months 5-8): Meetings once/ month for 70 min. for HE/PA-SB class, including 25 min. to discuss diet and PA-SB barriers. Goal: Exercise a minimum of 150-250 min./week. | Behavioural | Healthy Eating and Physical Activity - Intervention |
| TeleSalud General Health InterventionWeekly: Participants will meet via telehealth for 4 months (twice a week for 3 months and then once per week for 1 month) for a TeleSalud General Heath Class, after which they will attend one maintenance meeting per month for 4 months. Participants will meet and discuss general health topics (not diet or PA). Examples of the general health topics are: Back Pain, Muscle Strains, Alcohol Use, Stress \& Coping, Oral and Dental Health, Safety Tips, Emergency Preparedness. The content is relevant to Latinos, and information is focused on Latino men. Maintenance (Months 5-8): Participants will meet via telehealth once/ month for 70 min. to discuss general health topics. To enhance motivation to complete the study and assessments, this group will receive a copy of the TeleSalud HE-PA/SB intervention manual and related materials after the maintenance period ends. | Behavioural | General Health Topics - Control |
Primary outcome
Acceptability- Fidelity: Delivery
Time frame: 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- Fidelity: Receipt
Time frame: 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
Time frame: 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
Time frame: 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- Helpfulness/ Effectiveness of the Intervention Leaders
Time frame: 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.
Acceptability- Intervention Satisfaction
Time frame: 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).
Acceptability- Perceived Helpfulness/ Effectiveness of the Telehealth Modality, Technology, and Equipment
Time frame: 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.
Acceptability- Satisfaction with Random Assignment to Groups
Time frame: 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
Time frame: 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.
Dietary Intake: Number of Servings of Vegetables
Time frame: 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.
Dietary Intake: Percent of Calories from Saturated Fat
Time frame: 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.
Dietary Intake: Total Energy Intake
Time frame: 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- Adherence- Monthly Attendance
Time frame: 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 Make-Up Sessions
Time frame: 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- Number of Missed Sessions Overall
Time frame: 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- Adherence- Weekly Attendance
Time frame: 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
Time frame: Pre-Intervention
Recruitment feasibility assessed by the number of participants enrolled.
Feasibility- Recruitment- Number of Contacts
Time frame: Pre-Intervention
Recruitment feasibility assessed by counts of the number of contacts.
Feasibility- Recruitment- Rate of Consenting
Time frame: Pre-Intervention
Recruitment feasibility assessed by the rate of consenting.
Feasibility- Recruitment- Rate of Enrollment
Time frame: Pre-Intervention
Recruitment feasibility assessed by the rate of enrollment.
Feasibility- Recruitment- Rate of Screening
Time frame: Pre-Intervention
Recruitment feasibility assessed by the rate of screening.
Feasibility- Recruitment- Recruitment Method
Time frame: Pre-Intervention
Feasibility assessed by tracking the method of recruitment.
Feasibility- Recruitment- Response Rate
Time frame: Pre-Intervention
Recruitment feasibility assessed by rate of response.
Feasibility- Recruitment- Type of Contact
Time frame: Pre-Intervention
Recruitment feasibility assessed by tracking the type of contact.
Feasibility- Retention- Number Completed the intervention
Time frame: 4 months, 8 months
Retention assessed by counts and frequency of the number who completed the interventions.
Feasibility- Recruitment- Number Screened
Time frame: Pre-Intervention
Recruitment feasibility assessed by the count of number of individuals screened.
Feasibility- Retention- Number of Classes Attended
Time frame: 4 months, 8 months
Retention- assessed by counts of the number of classes attended.
Feasibility- Retention- Percent Completed the Interventions
Time frame: 4 months, 8 months
Retention assessed by the percent of participants who completed the interventions.
Feasibility- Retention- Percent of Classes Attended
Time frame: 4 months, 8 months
Retention assessed by percent of classes attended.
Feasibility- Recruitment- Number Consented
Time frame: Pre-Intervention
Recruitment feasibility assessed by the number of participants who consented.
Objective Physical Activity (Accelerometer)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 4 months, 8 months
The International Physical Activity Questionnaire long form- will measure sedentary and leisure and non-leisure time physical activity.
7 secondary outcomes
Body Mass Index
Time frame: Baseline, 4 months, 8 months
Outcome Expectations for Diet Questionnaire
Time frame: Baseline, 4 months, 8 months
Exercise Outcomes on the Outcomes Expectations Questionnaire
Time frame: Baseline, 4 months, 8 months
Self-Efficacy for Dietary Behaviors
Time frame: Baseline, 4 months, 8 months
Exercise Confidence Survey
Time frame: Baseline, 4 months, 8 months
Social Support and Eating Habits Survey
Time frame: Baseline, 4 months, 8 months
Social Support and Exercise Survey
Time frame: Baseline, 4 months, 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Overweight, Obesity
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Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Sanchez-Johnsen, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleSalud Healthy Eating- Physical Activity/Sedentary Behavior (HE-PA/SB) and TeleSalud General Health Intervention in people with Obesity, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Sanchez-Johnsen, PhD (414-955-8057, LSanchezJohnsen@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability- Fidelity: Delivery (time frame: 4 months, 8 months). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.