Motivational Interviewing for Getting Healthy TodaY Study (MIGHTY)

October 14, 2019 updated by: Columbia University

Computer-Assisted Motivational Interviewing Intervention to Facilitate Teen Pregnancy Prevention and Fitness Behavior Changes: A Randomized Trial for Young Men

The present study aims to test and rigorously evaluate the effectiveness of a computer-assisted motivational interviewing (CAMI) intervention that has already been shown to be successful with young women by reducing the risk of rapid subsequent birth among adolescent mothers, and applying this intervention to young men.

The purpose of the intervention is to increase condom use, increase female partner use of moderately or highly effective contraception, and increase completion of a reproductive health visit and STI/HIV testing.

The primary hypothesis is that the CAMI-TPP (CAMI aimed at Teen Pregnancy Prevention) intervention will increase the proportion of participants who do not engage in risky sex, report condom use at last intercourse as well as partner use of contraception compared to those in the Fitness group. It is also predicted that young men who receive the CAMI-TPP will report higher completion of a reproductive health service visit with sexually transmitted infection (STI) testing over the course of study participation compared to those in the CAMI-Fitness (CAMI aimed at healthy diet, physical activity and tobacco avoidance) group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Most teen pregnancies (82%) in the United States are unintended. Actively engaging young men in preventing teen pregnancy is a necessary and central component to effecting change. Young men, aged 15-19 and 20-24 years, father most of the children born to teen mothers. Few interventions have been designed specifically or shown to be effective for young men in reducing teen pregnancy.

Counseling and feedback based on Motivational Interviewing (MI) principles demonstrated greater success than standard, didactic advice in several domains of behavior change. The effectiveness of this type of counseling to alter young men's sexual and contraceptive behaviors has not been rigorously evaluated.

Participants will be randomly chosen (like flipping a coin) to take part in one of the two MI projects, and you will get coaching and use an app for that project to improve your health. One project is on teen pregnancy prevention and the other is on healthy eating, physical activity, and avoiding cigarettes. Participants will use an app via phone to do the project, answer survey questions, keep track of health, and learn more about healthy behaviors.

Three hundred young men, ages 15 to 24 years, will be randomized to one of two intervention arms, a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP) or a CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness). The two interventions are identical in length and timing but vary in the target behavior focus (pregnancy prevention versus fitness).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • George Washington Educational Campus School-Based Health Center
      • New York, New York, United States, 10032
        • The Young Men's Clinic
      • New York, New York, United States, 10463
        • John F. Kennedy Educational Campus School-Based Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 24 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Young men aged 15-24
  • Sexually active with female partners
  • Enrolled patients at New York Presbyterian Hospital's Young Men's Clinic (YMC) in Washington Heights or the school-based health centers (SBHCs) at George Washington Educational Campus in Washington Heights or John F. Kennedy campus in the Bronx

Exclusion Criteria:

  • Do not have iPhone or Android Smartphone

  • Participated in any of the following programs within the last year, or have a brother who has participated in these programs:

    • Fathers Raising Responsible Men (FRRM)
    • Peer Group Connection (PGC)
    • NYC Teens Connection
    • Children's AID Society (CAS)-TPP Initiative
    • Achieving Condom Empowerment-Plus (ACE+) Study
  • Have had a medical treatment or surgical procedure that makes it impossible to father a child, such as a vasectomy
  • Cannot commit to participating in a smartphone-based study for the next 15 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CAMI-TPP
Young men, ages 15 to 24 years, will be receiving a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP).
Behavioral: CAMI-TPP
The TPP group will receive four 30-minute sessions of one-on-one coaching over 12 weeks with a MI coach; the sessions will be guided by personalized feedback aimed at increasing condom use, supporting female partners in contraceptive use, and obtaining reproductive health services and STI testing. MI counseling sessions will be conducted by phone or video call.
Other Names:
  • CAMI - Teen Pregnancy Prevention
ACTIVE_COMPARATOR: CAMI-Fitness
Young men, ages 15 to 24 years, will be receiving CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness).
Behavioral: CAMI-Fitness
The Fitness group will also receive four 30-minute sessions of one-on-one coaching over 12 weeks with a MI coach; these sessions will be guided by personalized feedback aimed at healthy diet, physical activity and tobacco avoidance. MI counseling sessions will be conducted by phone or video call.
Other Names:
  • CAMI - healthy diet, physical activity and tobacco avoidance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in number of participants that had sexual intercourse without using a condom since the last assessment Condom use at last sex
Time Frame: Baseline and 12 weeks
In the past 3 months, how many times have you had sexual intercourse without using a condom?
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in number of participants that had sexual intercourse in the past without the partner using any contraception since the last assessment
Time Frame: Baseline and 12 weeks
In the past 3 months, how many times have you had sexual intercourse without using any of these methods of birth control?
Baseline and 12 weeks
Number of participants completing a reproductive health service visit with STI testing
Time Frame: Baseline and 12 weeks
In the last 3 months, that is, since {current date minus 3 months} , have you been tested by a doctor, nurse, or health provider for a sexually transmitted disease like gonorrhea, chlamydia, herpes, or syphilis (not including HIV)?
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention
The Office of Adolescent Health, HHS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David L. Bell, MD, MPH, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAR5303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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