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Motivational Interviewing for Getting Healthy TodaY Study (MIGHTY)

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Columbia University

Status

Completed

Conditions

Pregnancy Related
Diet Modification

Treatments

Behavioral: CAMI-Fitness
Behavioral: CAMI-TPP

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03410225
AAAR5303

Details and patient eligibility

About

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.

Full 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).

Enrollment

26 patients

Sex

Male

Ages

15 to 24 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

CAMI-TPP
Experimental group
Description:
Young men, ages 15 to 24 years, will be receiving a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP).
Treatment:
Behavioral: CAMI-TPP
CAMI-Fitness
Active Comparator group
Description:
Young men, ages 15 to 24 years, will be receiving CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness).
Treatment:
Behavioral: CAMI-Fitness

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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