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

NCT02993185 | Completed

• 1 other identifier: TP2AH000027
• Study Type: interventional
• Target: 808
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pregnancy; adolescents; sexually transmitted diseases; decision making; prevention education

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of incidents of vaginal intercourse

  3 months post intervention

• Condom errors or failure

  3 months post intervention

• Number of incidents of vaginal, oral, or anal sex without using condoms

  3 months post intervention

• Number of sexual partners for vaginal, oral, or anal intercourse

  3 months post intervention

• Perceived self efficacy to communicate about sexual boundaries and condom use

  3 months post intervention

Other Outcomes (14)

• STI knowledge

  3 months post intervention

• Perceived self efficacy to use condoms

  3 months post intervention

• Personal beliefs about what causes infertility

  3 months post intervention

Study Arms (2)

Your Move

EXPERIMENTAL

Sex education intervention

Behavioral: Your Move

Eat Smart

ACTIVE COMPARATOR

Nutrition education intervention

Behavioral: Eat Smart

Interventions

Your Move BEHAVIORAL

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.

Your Move

Eat Smart BEHAVIORAL

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.

Eat Smart

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female (or identify as female); age 14-19

You may not qualify if:

• Male (or identify as male); female older than 19 or younger than 14

Sponsors & Collaborators

• Carnegie Mellon University: lead
• ETR Associates: collaborator

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

Related 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. doi: 10.2174/1570162x13666150511145328.

  PMID: 26149165 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Pregnancy, Abdominal; Sexual Behavior; Sexually Transmitted Diseases; Feeding Behavior

Condition Hierarchy (Ancestors)

Pregnancy, Ectopic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior; Communicable Diseases; Infections; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Animal

Study Officials

• Julie Downs, PhD

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

• Pam Murray, MD, MHP

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 15, 2016
• Study Start: October 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)