<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993185</url>
  </required_header>
  <id_info>
    <org_study_id>TP2AH000027</org_study_id>
    <nct_id>NCT02993185</nct_id>
  </id_info>
  <brief_title>Making Healthy Decisions: A Trial Evaluating the &quot;Your Move&quot; Teen Pregnancy-prevention Intervention</brief_title>
  <official_title>An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carnegie Mellon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ETR Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Carnegie Mellon University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual&#xD;
      health education program, &quot;Your Move&quot; (YM) against a nutrition control program, &quot;Eat Smart&quot;&#xD;
      (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual&#xD;
      decisions with the ultimate goal of reducing unplanned pregnancies and STIs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Making Healthy Decisions includes two technology-based interventions designed to improve teen&#xD;
      females' healthy decision making in relation to sexual relationships (YM) and nutrition (ES).&#xD;
&#xD;
      Health educators from Planned Parenthood are trained to implement both YM and ES at&#xD;
      youth-serving community organizations in their geographic area across several U.S. states. In&#xD;
      a multi-site randomized controlled trial, females ages 14-19 are recruited from their local&#xD;
      community-based organization (CBO) into groups/cohorts of 8-12.&#xD;
&#xD;
      Each cohort is randomly assigned to participate in one of the two interventions prior to&#xD;
      baseline data collection.&#xD;
&#xD;
      Participants attend seven 75-minute program sessions that include facilitator-led games,&#xD;
      activities, and discussions as well as personal reflection time in which girls practiced&#xD;
      healthy decision making individually on an electronic tablet.&#xD;
&#xD;
      Self-reported survey data related to attitudes, knowledge, and behavior around sex and&#xD;
      nutrition are collected at baseline as well as 3 months after the intervention ends.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of sexual partners for vaginal intercourse</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Number of partners with whom had vaginal sex</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Number of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of incidents of vaginal sex without condoms</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Number of times reported having vaginal sex without using condoms or insertive condoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of incidents of vaginal intercourse</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Number of times had vaginal intercourse in the past 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Condom errors or failure</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>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 &amp; did not have another available, squeeze air from tip)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of incidents of vaginal, oral, or anal sex without using condoms</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Number of times reported having vaginal, oral, or anal sex without using condoms or insertive condoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sexual partners for vaginal, oral, or anal intercourse</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Number of partners with whom had vaginal, oral, or anal sex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived self efficacy to communicate about sexual boundaries and condom use</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Efficacy in communicating about sexual activity and condom use</description>
  </secondary_outcome>
  <other_outcome>
    <measure>STI knowledge</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Count of number of STI knowledge items correct out of 13.</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived self efficacy to use condoms</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Perceived efficacy to get and use condoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Personal beliefs about what causes infertility</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>General beliefs about infertility/fear about ability to get pregnant.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of sexual partners without using condoms</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Number of partners with whom had vaginal, oral, or anal sex without using condoms or insertive condoms</description>
  </other_outcome>
  <other_outcome>
    <measure>Birth control use</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>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, &quot;safe time of month,&quot; &quot;pull out&quot;), and emergency contraception</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutrition knowledge</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Count of number of nutrition knowledge items correct out of 10.</description>
  </other_outcome>
  <other_outcome>
    <measure>Personal attitudes toward healthy eating</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Mean score of 8 items on a 7 point scale on a newly developed questionnaire assessing healthy eating</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived self efficacy toward making healthy eating choices</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Perceived efficacy to eat recommended number of servings of fruit and vegetables each day, avoid sugary drinks and eat breakfast daily</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutrition behavior timeframe</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Number of days report eating fruit, vegetables, too much food, not enough food, dining out, preparing meal at home, and eating breakfast</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutrition behavior about quantity of fruit consumed</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Amount (# of cups) of fruit consumed on a typical day</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutrition behavior about quantity of vegetables consumed</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Amount (# of cups) of vegetables consumed on a typical day</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutrition behavior about quantity of sweetened beverage consumed</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Amount (# of cups) of sweetened beverage consumed on a typical day</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutrition behavior about food information when dining out</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Notice or check nutrition information (on menu or online) when dining out</description>
  </other_outcome>
  <other_outcome>
    <measure>Nutrition behavior about food information when shopping</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Notice or check nutrition information (food labels) when shopping</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">808</enrollment>
  <condition>Pregnancy, Abdominal</condition>
  <condition>Sexual Behavior</condition>
  <condition>Sexually Transmitted Infection</condition>
  <condition>Sexually Transmitted Diseases</condition>
  <condition>Dietary Modification</condition>
  <condition>Eating Behaviors</condition>
  <arm_group>
    <arm_group_label>Your Move</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sex education intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eat Smart</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutrition education intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Your Move</intervention_name>
    <description>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 &quot;personal reflection&quot; 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.</description>
    <arm_group_label>Your Move</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Eat Smart</intervention_name>
    <description>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 &quot;personal reflection&quot; 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.</description>
    <arm_group_label>Eat Smart</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female (or identify as female); age 14-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male (or identify as male); female older than 19 or younger than 14&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie Downs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carnegie Mellon University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pam Murray, MD, MHP</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carnegie Mellon University</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>26149165</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>25225369</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>15279915</PMID>
  </results_reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>May 21, 2021</last_update_submitted>
  <last_update_submitted_qc>May 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carnegie Mellon University</investigator_affiliation>
    <investigator_full_name>Julie Downs</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>adolescents</keyword>
  <keyword>sexually transmitted diseases</keyword>
  <keyword>decision making</keyword>
  <keyword>prevention education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
    <mesh_term>Pregnancy, Abdominal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993185
org study id: TP2AH000027
nct id: NCT02993185
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of sexual partners for vaginal intercourse
time frame: 3 months post intervention
description: Number of partners with whom had vaginal sex
measure: Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms
time frame: 3 months post intervention
description: Number of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms
measure: Number of incidents of vaginal sex without condoms
time frame: 3 months post intervention
description: Number of times reported having vaginal sex without using condoms or insertive condoms
measure: Number of incidents of vaginal intercourse
time frame: 3 months post intervention
description: Number of times had vaginal intercourse in the past 3 months
measure: Condom errors or failure
time frame: 3 months post intervention
description: 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)
measure: Number of incidents of vaginal, oral, or anal sex without using condoms
time frame: 3 months post intervention
description: Number of times reported having vaginal, oral, or anal sex without using condoms or insertive condoms
measure: Number of sexual partners for vaginal, oral, or anal intercourse
time frame: 3 months post intervention
description: Number of partners with whom had vaginal, oral, or anal sex
measure: Perceived self efficacy to communicate about sexual boundaries and condom use
time frame: 3 months post intervention
description: Efficacy in communicating about sexual activity and condom use
measure: STI knowledge
time frame: 3 months post intervention
description: Count of number of STI knowledge items correct out of 13.
measure: Perceived self efficacy to use condoms
time frame: 3 months post intervention
description: Perceived efficacy to get and use condoms.
measure: Personal beliefs about what causes infertility
time frame: 3 months post intervention
description: General beliefs about infertility/fear about ability to get pregnant.
measure: Number of sexual partners without using condoms
time frame: 3 months post intervention
description: Number of partners with whom had vaginal, oral, or anal sex without using condoms or insertive condoms
measure: Birth control use
time frame: 3 months post intervention
description: 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
measure: Nutrition knowledge
time frame: 3 months post intervention
description: Count of number of nutrition knowledge items correct out of 10.
measure: Personal attitudes toward healthy eating
time frame: 3 months post intervention
description: Mean score of 8 items on a 7 point scale on a newly developed questionnaire assessing healthy eating
measure: Perceived self efficacy toward making healthy eating choices
time frame: 3 months post intervention
description: Perceived efficacy to eat recommended number of servings of fruit and vegetables each day, avoid sugary drinks and eat breakfast daily
measure: Nutrition behavior timeframe
time frame: 3 months post intervention
description: Number of days report eating fruit, vegetables, too much food, not enough food, dining out, preparing meal at home, and eating breakfast
measure: Nutrition behavior about quantity of fruit consumed
time frame: 3 months post intervention
description: Amount (# of cups) of fruit consumed on a typical day
measure: Nutrition behavior about quantity of vegetables consumed
time frame: 3 months post intervention
description: Amount (# of cups) of vegetables consumed on a typical day
measure: Nutrition behavior about quantity of sweetened beverage consumed
time frame: 3 months post intervention
description: Amount (# of cups) of sweetened beverage consumed on a typical day
measure: Nutrition behavior about food information when dining out
time frame: 3 months post intervention
description: Notice or check nutrition information (on menu or online) when dining out
measure: Nutrition behavior about food information when shopping
time frame: 3 months post intervention
description: Notice or check nutrition information (food labels) when shopping
arm group label: Your Move
arm group type: Experimental
description: Sex education intervention
arm group label: Eat Smart
arm group type: Active Comparator
description: Nutrition education intervention
intervention type: Behavioral
intervention name: Your Move
description: 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.
arm group label: Your Move
intervention type: Behavioral
intervention name: Eat Smart
description: 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.
arm group label: Eat Smart
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: No
last name: Julie Downs, PhD
role: Principal Investigator
affiliation: Carnegie Mellon University
last name: Pam Murray, MD, MHP
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
citation: 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.
PMID: 26149165
citation: 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.
PMID: 25225369
citation: 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.
PMID: 15279915
responsible party type: Principal Investigator
investigator affiliation: Carnegie Mellon University
investigator full name: Julie Downs
investigator title: Associate Professor
mesh term: Sexually Transmitted Diseases
mesh term: Pregnancy, Abdominal
sharing ipd: No