- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02993185
Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention
An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Carnegie Mellon University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female (or identify as female); age 14-19
Exclusion Criteria:
- Male (or identify as male); female older than 19 or younger than 14
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Your Move
Sex education intervention
|
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.
|
Active Comparator: Eat Smart
Nutrition education intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of sexual partners for vaginal intercourse
Time Frame: 3 months post intervention
|
Number of partners with whom had vaginal sex
|
3 months post intervention
|
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
|
3 months post intervention
|
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
|
3 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of incidents of vaginal intercourse
Time Frame: 3 months post intervention
|
Number of times had vaginal intercourse in the past 3 months
|
3 months post intervention
|
Condom errors or failure
Time Frame: 3 months post intervention
|
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)
|
3 months post intervention
|
Number of incidents of vaginal, oral, or anal sex without using condoms
Time Frame: 3 months post intervention
|
Number of times reported having vaginal, oral, or anal sex without using condoms or insertive condoms
|
3 months post intervention
|
Number of sexual partners for vaginal, oral, or anal intercourse
Time Frame: 3 months post intervention
|
Number of partners with whom had vaginal, oral, or anal sex
|
3 months post intervention
|
Perceived self efficacy to communicate about sexual boundaries and condom use
Time Frame: 3 months post intervention
|
Efficacy in communicating about sexual activity and condom use
|
3 months post intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
STI knowledge
Time Frame: 3 months post intervention
|
Count of number of STI knowledge items correct out of 13.
|
3 months post intervention
|
Perceived self efficacy to use condoms
Time Frame: 3 months post intervention
|
Perceived efficacy to get and use condoms.
|
3 months post intervention
|
Personal beliefs about what causes infertility
Time Frame: 3 months post intervention
|
General beliefs about infertility/fear about ability to get pregnant.
|
3 months post intervention
|
Number of sexual partners without using condoms
Time Frame: 3 months post intervention
|
Number of partners with whom had vaginal, oral, or anal sex without using condoms or insertive condoms
|
3 months post intervention
|
Birth control use
Time Frame: 3 months post intervention
|
Use and consistency of use of 14 birth control methods (birth control pills, patch, Depo Provera, ring, IUD, implant, condoms, female condoms, diaphragm, cervical cap, sponge, spermicide, "safe time of month," "pull out"), and emergency contraception
|
3 months post intervention
|
Nutrition knowledge
Time Frame: 3 months post intervention
|
Count of number of nutrition knowledge items correct out of 10.
|
3 months post intervention
|
Personal attitudes toward healthy eating
Time Frame: 3 months post intervention
|
Mean score of 8 items on a 7 point scale on a newly developed questionnaire assessing healthy eating
|
3 months post intervention
|
Perceived self efficacy toward making healthy eating choices
Time Frame: 3 months post intervention
|
Perceived efficacy to eat recommended number of servings of fruit and vegetables each day, avoid sugary drinks and eat breakfast daily
|
3 months post intervention
|
Nutrition behavior timeframe
Time Frame: 3 months post intervention
|
Number of days report eating fruit, vegetables, too much food, not enough food, dining out, preparing meal at home, and eating breakfast
|
3 months post intervention
|
Nutrition behavior about quantity of fruit consumed
Time Frame: 3 months post intervention
|
Amount (# of cups) of fruit consumed on a typical day
|
3 months post intervention
|
Nutrition behavior about quantity of vegetables consumed
Time Frame: 3 months post intervention
|
Amount (# of cups) of vegetables consumed on a typical day
|
3 months post intervention
|
Nutrition behavior about quantity of sweetened beverage consumed
Time Frame: 3 months post intervention
|
Amount (# of cups) of sweetened beverage consumed on a typical day
|
3 months post intervention
|
Nutrition behavior about food information when dining out
Time Frame: 3 months post intervention
|
Notice or check nutrition information (on menu or online) when dining out
|
3 months post intervention
|
Nutrition behavior about food information when shopping
Time Frame: 3 months post intervention
|
Notice or check nutrition information (food labels) when shopping
|
3 months post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Downs, PhD, Carnegie Mellon University
- Principal Investigator: Pam Murray, MD, MHP, West Virginia University
Publications and helpful links
General 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.
- Downs 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.
- Downs 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP2AH000027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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