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

NCT ID: NCT02993185

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2020-12-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Your Move

Sex education intervention

Group Type EXPERIMENTAL

Your Move

Intervention Type 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.

Eat Smart

Nutrition education intervention

Group Type ACTIVE_COMPARATOR

Eat Smart

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ETR Associates

OTHER

Sponsor Role collaborator

Carnegie Mellon University

OTHER

Sponsor Role lead

Responsible Party

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Julie Downs

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Downs, PhD

Role: PRINCIPAL_INVESTIGATOR

Carnegie Mellon University

Pam Murray, MD, MHP

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

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Carnegie Mellon University

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26149165 (View on PubMed)

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.

Reference Type RESULT
PMID: 25225369 (View on PubMed)

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.

Reference Type RESULT
PMID: 15279915 (View on PubMed)

Other Identifiers

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TP2AH000027

Identifier Type: -

Identifier Source: org_study_id

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