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Completed

NCT Number: NCT02993185

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

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.

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Key information

Conditions

Pregnancy, Abdominal Behavior Behavior, Animal Communicable Diseases Dietary Modification Disease Attributes Eating Behaviors Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy, Ectopic Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Infection Urogenital Diseases

Age range

14 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of sexual partners for vaginal intercourse

    Time frame: 3 months post intervention

    Number of partners with whom had vaginal sex

  2. Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms

    Time frame: 3 months post intervention

    Number of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms

  3. Number of incidents of vaginal sex without condoms

    Time frame: 3 months post intervention

    Number of times reported having vaginal sex without using condoms or insertive condoms

Secondary outcomes

  1. Number of incidents of vaginal intercourse

    Time frame: 3 months post intervention

    Number of times had vaginal intercourse in the past 3 months

  2. Condom errors or failure

    Time frame: 3 months post intervention

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

    Time frame: 3 months post intervention

    Number of times reported having vaginal, oral, or anal sex without using condoms or insertive condoms

  4. Number of sexual partners for vaginal, oral, or anal intercourse

    Time frame: 3 months post intervention

    Number of partners with whom had vaginal, oral, or anal sex

  5. Perceived self efficacy to communicate about sexual boundaries and condom use

    Time frame: 3 months post intervention

    Efficacy in communicating about sexual activity and condom use

Other outcomes

  1. STI knowledge

    Time frame: 3 months post intervention

    Count of number of STI knowledge items correct out of 13.

  2. Perceived self efficacy to use condoms

    Time frame: 3 months post intervention

    Perceived efficacy to get and use condoms.

  3. Personal beliefs about what causes infertility

    Time frame: 3 months post intervention

    General beliefs about infertility/fear about ability to get pregnant.

  4. Number of sexual partners without using condoms

    Time frame: 3 months post intervention

    Number of partners with whom had vaginal, oral, or anal sex without using condoms or insertive condoms

  5. Birth control use

    Time frame: 3 months post intervention

    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

  6. Nutrition knowledge

    Time frame: 3 months post intervention

    Count of number of nutrition knowledge items correct out of 10.

  7. Personal attitudes toward healthy eating

    Time frame: 3 months post intervention

    Mean score of 8 items on a 7 point scale on a newly developed questionnaire assessing healthy eating

  8. Perceived self efficacy toward making healthy eating choices

    Time frame: 3 months post intervention

    Perceived efficacy to eat recommended number of servings of fruit and vegetables each day, avoid sugary drinks and eat breakfast daily

  9. Nutrition behavior timeframe

    Time frame: 3 months post intervention

    Number of days report eating fruit, vegetables, too much food, not enough food, dining out, preparing meal at home, and eating breakfast

  10. Nutrition behavior about quantity of fruit consumed

    Time frame: 3 months post intervention

    Amount (# of cups) of fruit consumed on a typical day

  11. Nutrition behavior about quantity of vegetables consumed

    Time frame: 3 months post intervention

    Amount (# of cups) of vegetables consumed on a typical day

  12. Nutrition behavior about quantity of sweetened beverage consumed

    Time frame: 3 months post intervention

    Amount (# of cups) of sweetened beverage consumed on a typical day

  13. Nutrition behavior about food information when dining out

    Time frame: 3 months post intervention

    Notice or check nutrition information (on menu or online) when dining out

  14. Nutrition behavior about food information when shopping

    Time frame: 3 months post intervention

    Notice or check nutrition information (food labels) when shopping

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • ETR Associates

Registry information

Official study title

An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 15, 2016
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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