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

An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02993185
Enrollment
808
Registered
2016-12-15
Start date
2016-10-01
Completion date
2020-12-31
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALYour 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.

BEHAVIORALEat 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.

Sponsors

ETR Associates
CollaboratorOTHER
Carnegie Mellon University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of sexual partners for vaginal intercourse3 months post interventionNumber of partners with whom had vaginal sex
Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms3 months post interventionNumber of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms
Number of incidents of vaginal sex without condoms3 months post interventionNumber of times reported having vaginal sex without using condoms or insertive condoms

Secondary

MeasureTime frameDescription
Number of sexual partners for vaginal, oral, or anal intercourse3 months post interventionNumber of partners with whom had vaginal, oral, or anal sex
Number of incidents of vaginal intercourse3 months post interventionNumber of times had vaginal intercourse in the past 3 months
Perceived self efficacy to communicate about sexual boundaries and condom use3 months post interventionEfficacy in communicating about sexual activity and condom use
Condom errors or failure3 months post interventionExperienced 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 condoms3 months post interventionNumber of times reported having vaginal, oral, or anal sex without using condoms or insertive condoms

Other

MeasureTime frameDescription
Nutrition behavior timeframe3 months post interventionNumber of days report eating fruit, vegetables, too much food, not enough food, dining out, preparing meal at home, and eating breakfast
Nutrition behavior about quantity of fruit consumed3 months post interventionAmount (# of cups) of fruit consumed on a typical day
Nutrition behavior about quantity of vegetables consumed3 months post interventionAmount (# of cups) of vegetables consumed on a typical day
STI knowledge3 months post interventionCount of number of STI knowledge items correct out of 13.
Nutrition behavior about food information when dining out3 months post interventionNotice or check nutrition information (on menu or online) when dining out
Nutrition behavior about food information when shopping3 months post interventionNotice or check nutrition information (food labels) when shopping
Nutrition behavior about quantity of sweetened beverage consumed3 months post interventionAmount (# of cups) of sweetened beverage consumed on a typical day
Perceived self efficacy to use condoms3 months post interventionPerceived efficacy to get and use condoms.
Personal beliefs about what causes infertility3 months post interventionGeneral beliefs about infertility/fear about ability to get pregnant.
Number of sexual partners without using condoms3 months post interventionNumber of partners with whom had vaginal, oral, or anal sex without using condoms or insertive condoms
Birth control use3 months post interventionUse 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
Nutrition knowledge3 months post interventionCount of number of nutrition knowledge items correct out of 10.
Personal attitudes toward healthy eating3 months post interventionMean score of 8 items on a 7 point scale on a newly developed questionnaire assessing healthy eating
Perceived self efficacy toward making healthy eating choices3 months post interventionPerceived efficacy to eat recommended number of servings of fruit and vegetables each day, avoid sugary drinks and eat breakfast daily

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026