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

Not Applicable

Completed

• Conditions: Sexually Transmitted Diseases; Dietary Modification; Eating Behaviors; Pregnancy, Abdominal; Sexual Behavior; Sexually Transmitted Infection
• Interventions: Behavioral: Eat Smart; Behavioral: Your Move

• Registration Number: NCT02993185
• Lead Sponsor: Carnegie Mellon University

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.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 808

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eat Smart	Eat Smart	Nutrition education intervention
Your Move	Your Move	Sex education intervention

Primary Outcome Measures

Name	Time	Method
Number of sexual partners for vaginal intercourse	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	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	3 months post intervention	Number of times reported having vaginal sex without using condoms or insertive condoms

Secondary Outcome Measures

Name	Time	Method
Number of incidents of vaginal intercourse	3 months post intervention	Number of times had vaginal intercourse in the past 3 months
Condom errors or failure	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)
Number of incidents of vaginal, oral, or anal sex without using condoms	3 months post intervention	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	3 months post intervention	Number of partners with whom had vaginal, oral, or anal sex
Perceived self efficacy to communicate about sexual boundaries and condom use	3 months post intervention	Efficacy in communicating about sexual activity and condom use

Trial Locations

Locations (1)

Carnegie Mellon University; 🇺🇸 Pittsburgh, Pennsylvania, United States