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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

26

Phase

  • 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

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
Intervention / Treatment
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

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

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

Columbia University

Collaborators

Centers for Disease Control and Prevention
The Office of Adolescent Health, HHS

Investigators

  • 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)

June 1, 2019

Primary Completion (ACTUAL)

August 28, 2019

Study Completion (ACTUAL)

August 28, 2019

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (ACTUAL)

January 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID 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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