Pregnancy, AbdominalNCT02993185
Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention
A study testing Your Move and Eat Smart in people with Pregnancy, Abdominal and Sexual Behavior, run by Carnegie Mellon University at 1 site in United States.
Trial summary
The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual health education program, "Your Move" (YM) against a nutrition control program, "Eat Smart" (ES). Read more about this study
- Who is it for?
- Ages 14 to 19 years, women only
- Conditions the study is for
- Pregnancy, Abdominal, Sexual Behavior, Sexually Transmitted Infection
- What is being tested?
- Your Move and Eat Smart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 808 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 31 Dec 2020
- 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 14 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female (or identify as female); age 14-19
Who cannot join
- Male (or identify as male); female older than 19 or younger than 14
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy
The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual health education program, "Your Move" (YM) against a nutrition control program, "Eat Smart" (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual decisions with the ultimate goal of reducing unplanned pregnancies and STIs.
Read the detailed description
Making Healthy Decisions includes two technology-based interventions designed to improve teen females' healthy decision making in relation to sexual relationships (YM) and nutrition (ES).
Health educators from Planned Parenthood are trained to implement both YM and ES at youth-serving community organizations in their geographic area across several U.S. states. In a multi-site randomized controlled trial, females ages 14-19 are recruited from their local community-based organization (CBO) into groups/cohorts of 8-12.
Each cohort is randomly assigned to participate in one of the two interventions prior to baseline data collection.
Participants attend seven 75-minute program sessions that include facilitator-led games, activities, and discussions as well as personal reflection time in which girls practiced healthy decision making individually on an electronic tablet.
Self-reported survey data related to attitudes, knowledge, and behavior around sex and nutrition are collected at baseline as well as 3 months after the intervention ends.
- Conditions
- Pregnancy, Abdominal, Sexual Behavior, Sexually Transmitted Infection, Sexually Transmitted Diseases, Dietary Modification, Eating Behaviors
- Being tested
- Your Move, Eat Smart
- Keywords
- pregnancy, adolescents, sexually transmitted diseases, decision making, prevention education
- Medical subject headings
- Pregnancy, Abdominal, Sexual Behavior, Sexually Transmitted Diseases, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Your MoveBehavioural
Your Move (YM) is an interactive sex education intervention. Groups of girls are randomly assigned to YM or Eat Smart (ES), a control interactive nutrition education intervention. Each program consist of seven 75-minute sessions, and each session contains 60 minutes of facilitator-led discussion, video clips, activities, and games as well as 15 minutes of "personal reflection" time during which girls practice the decision making skills they have learned. Participants complete online surveys about their attitudes, knowledge, and behavior related to food and nutrition and relationships and sex at baseline and also 3 months after the program ends.
Eat SmartBehavioural
Eat Smart (ES) is an interactive nutrition education intervention. Groups of girls are randomly assigned to ES or Your Move, an interactive sex education intervention. Each program consist of seven 75-minute sessions, and each session contains 60 minutes of facilitator-led discussion, video clips, activities, and games as well as 15 minutes of "personal reflection" time during which girls practice the decision making skills they have learned. Participants complete online surveys about their attitudes, knowledge, and behavior related to food and nutrition and relationships and sex at baseline and also 3 months after the program ends.
| Study group | Role | What they receive |
|---|---|---|
| Your Move | Experimental | Sex education intervention Receives: Behavioral: Your Move |
| Eat Smart | Active comparator | Nutrition education intervention Receives: Behavioral: Eat Smart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sexual partners for vaginal intercourse
Number of partners with whom had vaginal sex
Measured: 3 months post intervention
Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms
Number of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms
Measured: 3 months post intervention
Number of incidents of vaginal sex without condoms
Number of times reported having vaginal sex without using condoms or insertive condoms
Measured: 3 months post intervention
Secondary outcomes (5)
Number of incidents of vaginal intercourse
Number of times had vaginal intercourse in the past 3 months
Measured: 3 months post intervention
Condom errors or failure
Experienced any of 10 specific condom errors/failures during any condom use in the past 3 months (breakage, slippage, starting sex before putting condom on, removing condom before sex complete, open package with sharp object, use oil-based lubricant, put on condom before full erection, put on condom inside out and or flip it, had a problem that damaged condom \& did not have another available, squeeze air from tip)
Measured: 3 months post intervention
Number of incidents of vaginal, oral, or anal sex without using condoms
Number of times reported having vaginal, oral, or anal sex without using condoms or insertive condoms
Measured: 3 months post intervention
Number of sexual partners for vaginal, oral, or anal intercourse
Number of partners with whom had vaginal, oral, or anal sex
Measured: 3 months post intervention
Perceived self efficacy to communicate about sexual boundaries and condom use
Efficacy in communicating about sexual activity and condom use
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start1 Oct 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, AbdominalStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- ETR Associates
- Responsible party
- Principal investigator, Julie Downs, Carnegie Mellon University
- Investigators
- Julie Downs, PhD, Principal investigator, Carnegie Mellon UniversityPam Murray, MD, MHP, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993185
- Sponsor's protocol ID
- TP2AH000027
- Status last verified
- May 2021
- First submitted
- 28 Nov 2016
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Downs JS, Bruine de Bruin W, Fischhoff B, Murray PJ. Behavioral Decision Research Intervention Reduces Risky Sexual Behavior. Curr HIV Res. 2015;13(5):439-46. doi: 10.2174/1570162x13666150511145328.
PubMed 26149165Downs JS. Prescriptive scientific narratives for communicating usable science. Proc Natl Acad Sci U S A. 2014 Sep 16;111 Suppl 4(Suppl 4):13627-33. doi: 10.1073/pnas.1317502111. Epub 2014 Sep 15.
PubMed 25225369Downs JS, Murray PJ, Bruine de Bruin W, Penrose J, Palmgren C, Fischhoff B. Interactive video behavioral intervention to reduce adolescent females' STD risk: a randomized controlled trial. Soc Sci Med. 2004 Oct;59(8):1561-72. doi: 10.1016/j.socscimed.2004.01.032.
PubMed 15279915
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy
- ClinicalTrials.gov ID
- NCT02993185
- Acronym / sponsor ID
- TP2AH000027
- Conditions
- Pregnancy, Abdominal, Sexual Behavior, Sexually Transmitted Infection, Sexually Transmitted Diseases, Dietary Modification, Eating Behaviors
- Keywords
- pregnancy, adolescents, sexually transmitted diseases, decision making, prevention education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- ETR Associates
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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 purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual health education program, "Your Move" (YM) against a nutrition control program, "Eat Smart" (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual decisions with the ultimate goal of reducing unplanned pregnancies and STIs.
Detailed description
Making Healthy Decisions includes two technology-based interventions designed to improve teen females' healthy decision making in relation to sexual relationships (YM) and nutrition (ES).
Health educators from Planned Parenthood are trained to implement both YM and ES at youth-serving community organizations in their geographic area across several U.S. states. In a multi-site randomized controlled trial, females ages 14-19 are recruited from their local community-based organization (CBO) into groups/cohorts of 8-12.
Each cohort is randomly assigned to participate in one of the two interventions prior to baseline data collection.
Participants attend seven 75-minute program sessions that include facilitator-led games, activities, and discussions as well as personal reflection time in which girls practiced healthy decision making individually on an electronic tablet.
Self-reported survey data related to attitudes, knowledge, and behavior around sex and nutrition are collected at baseline as well as 3 months after the intervention ends.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Your Move | Experimental | Behavioral: Your MoveSex education intervention |
| Eat Smart | Active comparator | Behavioral: Eat SmartNutrition education intervention |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Female (or identify as female); age 14-19
Key exclusion criteria (1 listed)
- Male (or identify as male); female older than 19 or younger than 14
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 |
|---|---|---|
| Your MoveYour Move (YM) is an interactive sex education intervention. Groups of girls are randomly assigned to YM or Eat Smart (ES), a control interactive nutrition education intervention. Each program consist of seven 75-minute sessions, and each session contains 60 minutes of facilitator-led discussion, video clips, activities, and games as well as 15 minutes of "personal reflection" time during which girls practice the decision making skills they have learned. Participants complete online surveys about their attitudes, knowledge, and behavior related to food and nutrition and relationships and sex at baseline and also 3 months after the program ends. | Behavioural | Your Move |
| Eat SmartEat Smart (ES) is an interactive nutrition education intervention. Groups of girls are randomly assigned to ES or Your Move, an interactive sex education intervention. Each program consist of seven 75-minute sessions, and each session contains 60 minutes of facilitator-led discussion, video clips, activities, and games as well as 15 minutes of "personal reflection" time during which girls practice the decision making skills they have learned. Participants complete online surveys about their attitudes, knowledge, and behavior related to food and nutrition and relationships and sex at baseline and also 3 months after the program ends. | Behavioural | Eat Smart |
Primary outcome
Number of sexual partners for vaginal intercourse
Time frame: 3 months post intervention
Number of partners with whom had vaginal sex
Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms
Time frame: 3 months post intervention
Number of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms
Number of incidents of vaginal sex without condoms
Time frame: 3 months post intervention
Number of times reported having vaginal sex without using condoms or insertive condoms
5 secondary outcomes
Number of incidents of vaginal intercourse
Time frame: 3 months post intervention
Condom errors or failure
Time frame: 3 months post intervention
Number of incidents of vaginal, oral, or anal sex without using condoms
Time frame: 3 months post intervention
Number of sexual partners for vaginal, oral, or anal intercourse
Time frame: 3 months post intervention
Perceived self efficacy to communicate about sexual boundaries and condom use
Time frame: 3 months post intervention
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 24 May 2021.
- Results publication: PubMed 26149165Downs JS, Bruine de Bruin W, Fischhoff B, Murray PJ. Behavioral Decision Research Intervention Reduces Risky Sexual Behavior. Curr HIV Res. 2015;13(5):439-46. doi: 10.2174/1570162x13666150511145328.
- Results publication: PubMed 25225369Downs JS. Prescriptive scientific narratives for communicating usable science. Proc Natl Acad Sci U S A. 2014 Sep 16;111 Suppl 4(Suppl 4):13627-33. doi: 10.1073/pnas.1317502111. Epub 2014 Sep 15.
- Results publication: PubMed 15279915Downs JS, Murray PJ, Bruine de Bruin W, Penrose J, Palmgren C, Fischhoff B. Interactive video behavioral intervention to reduce adolescent females' STD risk: a randomized controlled trial. Soc Sci Med. 2004 Oct;59(8):1561-72. doi: 10.1016/j.socscimed.2004.01.032.
- 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.
Julie Downs, PhD principal investigator
Carnegie Mellon University
Pam Murray, MD, MHP principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Your Move and Eat Smart in people with Pregnancy, Abdominal and Sexual Behavior, run by Carnegie Mellon University at 1 site 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 1 inclusion and 1 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 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of sexual partners for vaginal intercourse (time frame: 3 months post intervention). The study lists 3 primary outcomes in all. 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 NCT02993185, which also lists 3 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 24 May 2021.