Pregnancy RelatedMIGHTYNCT03410225
Motivational Interviewing for Getting Healthy TodaY Study
A study testing CAMI-TPP and CAMI-Fitness in people with Pregnancy Related and Diet Modification, run by Columbia University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Diet Modification
- What is being tested?
- CAMI-TPP and CAMI-Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2019to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
George Washington Educational Campus School-Based Health Center
New York, New York, 10032
The Young Men's Clinic
New York, New York, 10032
John F. Kennedy Educational Campus School-Based Health Center
New York, New York, 10463
About this study
Official title: 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.
Read the 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).
- Conditions
- Pregnancy Related, Diet Modification
- Being tested
- CAMI-TPP, CAMI-Fitness
- Keywords
- Pregnancy Prevention, Male Involvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMI-TPPBehavioural
Also called CAMI - Teen Pregnancy Prevention
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-FitnessBehavioural
Also called CAMI - healthy diet, physical activity and tobacco avoidance
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.
| Study group | Role | What they receive |
|---|---|---|
| CAMI-TPP | Experimental | Young men, ages 15 to 24 years, will be receiving a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP). Receives: Behavioral: CAMI-TPP |
| CAMI-Fitness | Active comparator | Young men, ages 15 to 24 years, will be receiving CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness). Receives: Behavioral: CAMI-Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of participants that had sexual intercourse without using a condom since the last assessment Condom use at last sex
In the past 3 months, how many times have you had sexual intercourse without using a condom?
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Change in number of participants that had sexual intercourse in the past without the partner using any contraception since the last assessment
In the past 3 months, how many times have you had sexual intercourse without using any of these methods of birth control?
Measured: Baseline and 12 weeks
Number of participants completing a reproductive health service visit with STI testing
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)?
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Jun 2019
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- David L. Bell, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410225
- Sponsor's protocol ID
- AAAR5303
- Acronym
- MIGHTY
- Status last verified
- Oct 2019
- First submitted
- 9 Jan 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24354819Martin 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.
PubMed 24974589Males MA. Adult involvement in teenage childbearing and STD. Lancet. 1995 Jul 8;346(8967):64-5. doi: 10.1016/s0140-6736(95)92105-2.
PubMed 7603210Hollis 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.
PubMed 15805374McCambridge 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.
PubMed 14678061Weinstein 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.
PubMed 16803808Jensen 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.
PubMed 21728400Channon 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.
PubMed 17351283
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Motivational Interviewing Intervention to Facilitate Teen Pregnancy Prevention and Fitness Behavior Changes: A Randomized Trial for Young Men
- ClinicalTrials.gov ID
- NCT03410225
- Acronym / sponsor ID
- MIGHTY / AAAR5303
- Conditions
- Pregnancy Related, Diet Modification
- Keywords
- Pregnancy Prevention, Male Involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS, Centers for Disease Control and Prevention
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CAMI-TPP | Experimental | Behavioral: CAMI-TPPYoung men, ages 15 to 24 years, will be receiving a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP). |
| CAMI-Fitness | Active comparator | Behavioral: CAMI-FitnessYoung men, ages 15 to 24 years, will be receiving CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness). |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMI-TPPAlso: CAMI - Teen Pregnancy PreventionThe 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. | Behavioural | CAMI-TPP |
| CAMI-FitnessAlso: CAMI - healthy diet, physical activity and tobacco avoidanceThe 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. | Behavioural | CAMI-Fitness |
Primary outcome
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?
2 secondary outcomes
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
Number of participants completing a reproductive health service visit with STI testing
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Background: PubMed 24354819Finer 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.
- Background: PubMed 24974589Martin 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.
- Background: PubMed 7603210Males MA. Adult involvement in teenage childbearing and STD. Lancet. 1995 Jul 8;346(8967):64-5. doi: 10.1016/s0140-6736(95)92105-2.
- Background: PubMed 15805374Hollis 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.
- Background: PubMed 14678061McCambridge 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.
- Background: PubMed 16803808Weinstein 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.
- Background: PubMed 21728400Jensen 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.
- Background: PubMed 17351283Channon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L. Bell, MD, MPH principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMI-TPP and CAMI-Fitness in people with Pregnancy Related and Diet Modification, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03410225, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.