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Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention

Primary Purpose

Pregnancy, Abdominal, Sexual Behavior, Sexually Transmitted Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Your Move
Eat Smart
Sponsored by
Carnegie Mellon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy, Abdominal focused on measuring pregnancy, adolescents, sexually transmitted diseases, decision making, prevention education

Eligibility Criteria

14 Years - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Carnegie Mellon University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Your Move

Eat Smart

Arm Description

Sex education intervention

Nutrition education intervention

Outcomes

Primary Outcome Measures

Number of sexual partners for vaginal intercourse
Number of partners with whom had vaginal sex
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
Number of incidents of vaginal sex without condoms
Number of times reported having vaginal sex without using condoms or insertive condoms

Secondary Outcome Measures

Number of incidents of vaginal intercourse
Number of times had vaginal intercourse in the past 3 months
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)
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
Number of sexual partners for vaginal, oral, or anal intercourse
Number of partners with whom had vaginal, oral, or anal sex
Perceived self efficacy to communicate about sexual boundaries and condom use
Efficacy in communicating about sexual activity and condom use

Full Information

First Posted
November 28, 2016
Last Updated
May 21, 2021
Sponsor
Carnegie Mellon University
Collaborators
ETR Associates
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1. Study Identification

Unique Protocol Identification Number
NCT02993185
Brief Title
Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention
Official Title
An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carnegie Mellon University
Collaborators
ETR Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Abdominal, Sexual Behavior, Sexually Transmitted Infection, Sexually Transmitted Diseases, Dietary Modification, Eating Behaviors
Keywords
pregnancy, adolescents, sexually transmitted diseases, decision making, prevention education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
808 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Your Move
Arm Type
Experimental
Arm Description
Sex education intervention
Arm Title
Eat Smart
Arm Type
Active Comparator
Arm Description
Nutrition education intervention
Intervention Type
Behavioral
Intervention Name(s)
Your Move
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Eat Smart
Intervention 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.
Primary Outcome Measure Information:
Title
Number of sexual partners for vaginal intercourse
Description
Number of partners with whom had vaginal sex
Time Frame
3 months post intervention
Title
Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms
Description
Number of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms
Time Frame
3 months post intervention
Title
Number of incidents of vaginal sex without condoms
Description
Number of times reported having vaginal sex without using condoms or insertive condoms
Time Frame
3 months post intervention
Secondary Outcome Measure Information:
Title
Number of incidents of vaginal intercourse
Description
Number of times had vaginal intercourse in the past 3 months
Time Frame
3 months post intervention
Title
Condom errors or failure
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)
Time Frame
3 months post intervention
Title
Number of incidents of vaginal, oral, or anal sex without using condoms
Description
Number of times reported having vaginal, oral, or anal sex without using condoms or insertive condoms
Time Frame
3 months post intervention
Title
Number of sexual partners for vaginal, oral, or anal intercourse
Description
Number of partners with whom had vaginal, oral, or anal sex
Time Frame
3 months post intervention
Title
Perceived self efficacy to communicate about sexual boundaries and condom use
Description
Efficacy in communicating about sexual activity and condom use
Time Frame
3 months post intervention
Other Pre-specified Outcome Measures:
Title
STI knowledge
Description
Count of number of STI knowledge items correct out of 13.
Time Frame
3 months post intervention
Title
Perceived self efficacy to use condoms
Description
Perceived efficacy to get and use condoms.
Time Frame
3 months post intervention
Title
Personal beliefs about what causes infertility
Description
General beliefs about infertility/fear about ability to get pregnant.
Time Frame
3 months post intervention
Title
Number of sexual partners without using condoms
Description
Number of partners with whom had vaginal, oral, or anal sex without using condoms or insertive condoms
Time Frame
3 months post intervention
Title
Birth control use
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
Time Frame
3 months post intervention
Title
Nutrition knowledge
Description
Count of number of nutrition knowledge items correct out of 10.
Time Frame
3 months post intervention
Title
Personal attitudes toward healthy eating
Description
Mean score of 8 items on a 7 point scale on a newly developed questionnaire assessing healthy eating
Time Frame
3 months post intervention
Title
Perceived self efficacy toward making healthy eating choices
Description
Perceived efficacy to eat recommended number of servings of fruit and vegetables each day, avoid sugary drinks and eat breakfast daily
Time Frame
3 months post intervention
Title
Nutrition behavior timeframe
Description
Number of days report eating fruit, vegetables, too much food, not enough food, dining out, preparing meal at home, and eating breakfast
Time Frame
3 months post intervention
Title
Nutrition behavior about quantity of fruit consumed
Description
Amount (# of cups) of fruit consumed on a typical day
Time Frame
3 months post intervention
Title
Nutrition behavior about quantity of vegetables consumed
Description
Amount (# of cups) of vegetables consumed on a typical day
Time Frame
3 months post intervention
Title
Nutrition behavior about quantity of sweetened beverage consumed
Description
Amount (# of cups) of sweetened beverage consumed on a typical day
Time Frame
3 months post intervention
Title
Nutrition behavior about food information when dining out
Description
Notice or check nutrition information (on menu or online) when dining out
Time Frame
3 months post intervention
Title
Nutrition behavior about food information when shopping
Description
Notice or check nutrition information (food labels) when shopping
Time Frame
3 months post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Downs, PhD
Organizational Affiliation
Carnegie Mellon University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pam Murray, MD, MHP
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carnegie Mellon University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26149165
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.
Results Reference
result
PubMed Identifier
25225369
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.
Results Reference
result
PubMed Identifier
15279915
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.
Results Reference
result

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Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention

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