Motivational Interviewing for Getting Healthy TodaY Study
Condition: Pregnancy Related; Diet Modification
Study type: Interventional

Summary: 
      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.
    

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).
    

Intervention name(s): CAMI-TPP; CAMI-Fitness
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 intervention name(s): CAMI - Teen Pregnancy Prevention; CAMI - healthy diet, physical activity and tobacco avoidance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized through a permuted random blocks assignment procedure with block stratification (by age group). Strings of varying length (2, 4, 6, 8, for example), with equal allocations T and C (randomly ordered) within a string, are combined to produce a single, long string of T and C combinations (e.g. TTCCTCTTCCC, etc.). Because the long string is made up of blocks of T and C strings with equal allocations of Ts and Cs, the observed percentage of the sample in the treatment condition will always be very close to 0.5, and the true P(T) for all observations will be 0.5. Randomization will be conducted via an algorithm on the online portal at the time of enrollment in order for the project coordinator to assign the participant to an intervention arm.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy Prevention; Male Involvement