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

Sexually Transmitted Diseases Clinical Trial

Official title:

An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993185
• Other study ID #: TP2AH000027
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 808
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Your Move
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.
• Eat Smart
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.

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Carnegie Mellon University	ETR Associates

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Downs JS. Prescriptive scientific narratives for communicating usable science. Proc Natl Acad Sci U S A. 2014 Sep 16;111 Suppl 4:13627-33. doi: 10.1073/pnas.1317502111. Epub 2014 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	STI knowledge	Count of number of STI knowledge items correct out of 13.	3 months post intervention
Other	Perceived self efficacy to use condoms	Perceived efficacy to get and use condoms.	3 months post intervention
Other	Personal beliefs about what causes infertility	General beliefs about infertility/fear about ability to get pregnant.	3 months post intervention
Other	Number of sexual partners without using condoms	Number of partners with whom had vaginal, oral, or anal sex without using condoms or insertive condoms	3 months post intervention
Other	Birth control use	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
Other	Nutrition knowledge	Count of number of nutrition knowledge items correct out of 10.	3 months post intervention
Other	Personal attitudes toward healthy eating	Mean score of 8 items on a 7 point scale on a newly developed questionnaire assessing healthy eating	3 months post intervention
Other	Perceived self efficacy toward making healthy eating choices	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
Other	Nutrition behavior timeframe	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
Other	Nutrition behavior about quantity of fruit consumed	Amount (# of cups) of fruit consumed on a typical day	3 months post intervention
Other	Nutrition behavior about quantity of vegetables consumed	Amount (# of cups) of vegetables consumed on a typical day	3 months post intervention
Other	Nutrition behavior about quantity of sweetened beverage consumed	Amount (# of cups) of sweetened beverage consumed on a typical day	3 months post intervention
Other	Nutrition behavior about food information when dining out	Notice or check nutrition information (on menu or online) when dining out	3 months post intervention
Other	Nutrition behavior about food information when shopping	Notice or check nutrition information (food labels) when shopping	3 months post intervention
Primary	Number of sexual partners for vaginal intercourse	Number of partners with whom had vaginal sex	3 months post intervention
Primary	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
Primary	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	Number of incidents of vaginal intercourse	Number of times had vaginal intercourse in the past 3 months	3 months post intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	Perceived self efficacy to communicate about sexual boundaries and condom use	Efficacy in communicating about sexual activity and condom use	3 months post intervention