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Behavioural Intervention

Nutrition and physical activity (STYH) for Knowledge (STEPS2 Trial)

N/A

Recruiting

Led By Heidi E Jones, PhD

Research Sponsored by City University of New York, School of Public Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

16-27 years of age

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post enrollment

Awards & highlights

STEPS2 Trial Summary

This trial is testing a 6-week program called STEPS2 that aims to teach young people with intellectual and developmental disabilities about sexual health. The trial wants to find out if the program helps individuals have

Who is the study for?

This trial is for young people aged 16-27 with intellectual and developmental disabilities, including those with Down syndrome. They should be interested in learning about sexual health or improving physical health through nutrition and exercise.Check my eligibility

What is being tested?

The STEPS2 curriculum aims to improve sexual health knowledge and behaviors in participants by offering one-on-one education sessions. It's being compared to a group-based program focused on nutrition and exercise called STYH.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, there are no direct side effects like you'd expect from medication. However, participants may experience emotional or psychological responses to the content.

STEPS2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 16 and 27 years old.

STEPS2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year post enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion who can accurately describe how a person gets pregnant

Proportion who can accurately describe what sex is

Proportion who have been vaccinated for HPV

+2 more

Secondary outcome measures

Average satisfaction with intervention score (1 to 5, with 5 being very satisfied)

Average sexual health knowledge score (1-25, with 25 being high knowledge)

Proportion tested for STDs among those reporting vaginal and/or anal sex

+2 more

STEPS2 Trial Design

2Treatment groups

Experimental Treatment

Group I: Socialization and sex education (STEPS2)Experimental Treatment1 Intervention

Weekly virtual one hour one-on-one sessions with Study Health Educator on the STEPS2 curriculum for 6-weeks. Topics include: the human body, decision-making, sexually transmitted diseases, pregnancy, birth control, pregnancy and parenting, and going to the doctor.

Group II: Nutrition and physical activity (STYH)Experimental Treatment1 Intervention

The comparison curriculum has been shown in a previous study to improve knowledge around nutrition and exercise, but should not change sexual and reproductive health outcomes. Weekly virtual one hour group sessions (6-10 participants) with Study Health Educator on the Steps To Your Health (STYH) curriculum for 6-weeks. Topics include: nutrition, exercise, stress management, changing your way of thinking, and behaviors to stay healthy.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

National Institutes of Health INCLUDE ProjectUNKNOWN

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,671,941 Total Patients Enrolled

1 Trials studying Knowledge

180 Patients Enrolled for Knowledge

National Institutes of Health Office of Disease PreventionUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are older than 18 years eligible to participate in this recruitment process for the trial?

"As per the eligibility requirements outlined in this study, participants must be between the ages of 16 and 27 to be considered for inclusion."

Answered by AI

What are the objectives of this particular research endeavor?

"The primary objective of this research, to be assessed within a one-year period after enrollment, is to determine the percentage of participants capable of accurately explaining the process of conception. Secondary endpoints encompass evaluating the rate at which individuals practicing vaginal intercourse employ contraception (defined as self-reported use), assessing condom usage among those engaging in vaginal and/or anal intercourse (also defined by self-reporting), and determining rates of sexually transmitted disease testing among individuals participating in vaginal and/or anal intercourse (again determined through self-reporting)."

Answered by AI

Is the enrollment for participants in this study currently ongoing?

"As per the information available on clinicaltrials.gov, this ongoing research study is actively seeking eligible participants. The trial was initially posted on October 20, 2023 and underwent its most recent update on January 29, 2024."

Answered by AI

What is the total number of participants being recruited for this research investigation?

"Indeed, the information available on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking individuals to participate. The trial was initially posted on October 20th, 2023 and underwent its most recent update on January 29th, 2024. A total of 856 participants will be enrolled at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Socialization To Enrich Participation & Support Sexuality for Young People With I/DD

2023. "Socialization To Enrich Participation & Support Sexuality for Young People With I/DD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06231485.