Motivational Interviewing for Getting Healthy TodaY Study

NCT ID: NCT03410225

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-08-28

Brief Summary

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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

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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).

Conditions

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Pregnancy Related Diet Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CAMI-TPP

Young men, ages 15 to 24 years, will be receiving a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP).

Group Type EXPERIMENTAL

CAMI-TPP

Intervention Type BEHAVIORAL

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.

CAMI-Fitness

Young men, ages 15 to 24 years, will be receiving CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness).

Group Type ACTIVE_COMPARATOR

CAMI-Fitness

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CAMI - Teen Pregnancy Prevention CAMI - healthy diet, physical activity and tobacco avoidance

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Office of Adolescent Health, HHS

FED

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David L. Bell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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George Washington Educational Campus School-Based Health Center

New York, New York, United States

Site Status

The Young Men's Clinic

New York, New York, United States

Site Status

John F. Kennedy Educational Campus School-Based Health Center

New York, New York, United States

Site Status

Countries

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United States

References

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Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001-2008. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S43-8. doi: 10.2105/AJPH.2013.301416. Epub 2013 Dec 19.

Reference Type BACKGROUND
PMID: 24354819 (View on PubMed)

Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72.

Reference Type BACKGROUND
PMID: 24974589 (View on PubMed)

Males MA. Adult involvement in teenage childbearing and STD. Lancet. 1995 Jul 8;346(8967):64-5. doi: 10.1016/s0140-6736(95)92105-2.

Reference Type BACKGROUND
PMID: 7603210 (View on PubMed)

Hollis JF, Polen MR, Whitlock EP, Lichtenstein E, Mullooly JP, Velicer WF, Redding CA. Teen reach: outcomes from a randomized, controlled trial of a tobacco reduction program for teens seen in primary medical care. Pediatrics. 2005 Apr;115(4):981-9. doi: 10.1542/peds.2004-0981.

Reference Type BACKGROUND
PMID: 15805374 (View on PubMed)

McCambridge J, Strang J. The efficacy of single-session motivational interviewing in reducing drug consumption and perceptions of drug-related risk and harm among young people: results from a multi-site cluster randomized trial. Addiction. 2004 Jan;99(1):39-52. doi: 10.1111/j.1360-0443.2004.00564.x.

Reference Type BACKGROUND
PMID: 14678061 (View on PubMed)

Weinstein P, Harrison R, Benton T. Motivating mothers to prevent caries: confirming the beneficial effect of counseling. J Am Dent Assoc. 2006 Jun;137(6):789-93. doi: 10.14219/jada.archive.2006.0291.

Reference Type BACKGROUND
PMID: 16803808 (View on PubMed)

Jensen CD, Cushing CC, Aylward BS, Craig JT, Sorell DM, Steele RG. Effectiveness of motivational interviewing interventions for adolescent substance use behavior change: a meta-analytic review. J Consult Clin Psychol. 2011 Aug;79(4):433-40. doi: 10.1037/a0023992.

Reference Type BACKGROUND
PMID: 21728400 (View on PubMed)

Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.

Reference Type BACKGROUND
PMID: 17351283 (View on PubMed)

Other Identifiers

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AAAR5303

Identifier Type: -

Identifier Source: org_study_id

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