Clinical trial NCT02993185: Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention
Official title: An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: ETR Associates
First posted: 2016-12-15
Enrollment: 808
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of sexual partners for vaginal intercourse
timeFrame: 3 months post intervention
measure: Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms
timeFrame: 3 months post intervention
measure: Number of incidents of vaginal sex without condoms
timeFrame: 3 months post intervention
Secondary outcomes:
measure: Number of incidents of vaginal intercourse
timeFrame: 3 months post intervention
measure: Condom errors or failure
timeFrame: 3 months post intervention
measure: Number of incidents of vaginal, oral, or anal sex without using condoms
timeFrame: 3 months post intervention
measure: Number of sexual partners for vaginal, oral, or anal intercourse
timeFrame: 3 months post intervention
measure: Perceived self efficacy to communicate about sexual boundaries and condom use
timeFrame: 3 months post intervention
Other outcomes:
measure: STI knowledge
timeFrame: 3 months post intervention
measure: Perceived self efficacy to use condoms
timeFrame: 3 months post intervention
measure: Personal beliefs about what causes infertility
timeFrame: 3 months post intervention
measure: Number of sexual partners without using condoms
timeFrame: 3 months post intervention
measure: Birth control use
timeFrame: 3 months post intervention
measure: Nutrition knowledge
timeFrame: 3 months post intervention
measure: Personal attitudes toward healthy eating
timeFrame: 3 months post intervention
measure: Perceived self efficacy toward making healthy eating choices
timeFrame: 3 months post intervention
measure: Nutrition behavior timeframe
timeFrame: 3 months post intervention
measure: Nutrition behavior about quantity of fruit consumed
timeFrame: 3 months post intervention
measure: Nutrition behavior about quantity of vegetables consumed
timeFrame: 3 months post intervention
measure: Nutrition behavior about quantity of sweetened beverage consumed
timeFrame: 3 months post intervention
measure: Nutrition behavior about food information when dining out
timeFrame: 3 months post intervention
measure: Nutrition behavior about food information when shopping
timeFrame: 3 months post intervention
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Julie Downs, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Pam Murray, MD, MHP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1016/j.socscimed.2004.01.032.