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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy

Conditions
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Pregnancy, Abdominal, Sexual Behavior, Sexually Transmitted Infection, Sexually Transmitted Diseases, Dietary Modification, Eating Behaviors

Intervention / Treatment
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* Behavioral: Your Move
* Behavioral: Eat Smart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Your Move<br>Sex education intervention | Behavioral: Your Move<br>* 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.<br>|
| Active Comparator: Eat Smart<br>Nutrition education intervention | Behavioral: Eat Smart<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sexual partners for vaginal intercourse | 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 | 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 | 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 | Number of times had vaginal intercourse in the past 3 months | 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) | 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 | 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 | 3 months post intervention | 
| Perceived self efficacy to communicate about sexual boundaries and condom use | Efficacy in communicating about sexual activity and condom use | 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, adolescents, sexually transmitted diseases, decision making, prevention education