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Making Healthy Decisions (MHD)

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ClinicalTrials.gov Identifier: NCT02993185
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
ETR Associates
Information provided by (Responsible Party):
Julie Downs, Carnegie Mellon University

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.

Condition or disease Intervention/treatment Phase
Pregnancy, Abdominal Sexual Behavior Sexually Transmitted Infection Sexually Transmitted Diseases Dietary Modification Eating Behaviors Behavioral: Your Move Behavioral: Eat Smart Not Applicable

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 and 9 months after the intervention ends.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy
Study Start Date : October 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Your Move
Sex education intervention
Behavioral: 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 and 9 months after the program ends.

Active Comparator: Eat Smart
Nutrition education intervention
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 and 9 months after the program ends.




Primary Outcome Measures :
  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 sexual partners for vaginal intercourse [ Time Frame: 9 months post intervention ]
    Number of partners with whom had vaginal sex

  3. 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

  4. Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms [ Time Frame: 9 months post intervention ]
    Number of times reported having vaginal sex without hormonal contraception, copper

  5. 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

  6. Number of incidents of vaginal sex without condoms [ Time Frame: 9 months post intervention ]
    Number of times reported having vaginal sex without using condoms or insertive condoms


Secondary Outcome Measures :
  1. Number of incidents of vaginal intercourse [ Time Frame: 3 and 9 months post intervention ]
    Number of times had vaginal intercourse in the past 3 months

  2. Condom errors or failure [ Time Frame: 3 and 9 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 and 9 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 and 9 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 and 9 months post intervention ]
    Efficacy in communicating about sexual activity and condom use


Other Outcome Measures:
  1. STI knowledge [ Time Frame: 3 months post intervention ]
    Count of number of STI knowledge items correct out of 13.

  2. STI knowledge [ Time Frame: 9 months post intervention ]
    Count of number of STI knowledge items correct out of 13.

  3. Perceived self efficacy to use condoms [ Time Frame: 3 months post intervention ]
    Perceived efficacy to get and use condoms.

  4. Perceived self efficacy to use condoms [ Time Frame: 9 months post intervention ]
    Perceived efficacy to get and use condoms.

  5. Personal beliefs about what causes infertility [ Time Frame: 3 months post intervention ]
    General beliefs about infertility/fear about ability to get pregnant.

  6. Personal beliefs about what causes infertility [ Time Frame: 9 months post intervention ]
    General beliefs about infertility/fear about ability to get pregnant.

  7. 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

  8. Number of sexual partners without using condoms [ Time Frame: 9 months post intervention ]
    Number of partners with whom had vaginal, oral, or anal sex without using condoms or insertive condoms

  9. 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

  10. Birth control use [ Time Frame: 9 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

  11. Nutrition knowledge [ Time Frame: 3 months post intervention ]
    Count of number of nutrition knowledge items correct out of 10.

  12. Nutrition knowledge [ Time Frame: 9 months post intervention ]
    Count of number of nutrition knowledge items correct out of 10.

  13. 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

  14. Personal attitudes toward healthy eating [ Time Frame: 9 months post intervention ]
    Mean score of 8 items on a 7 point scale on a newly developed questionnaire assessing healthy eating

  15. 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

  16. Perceived self efficacy toward making healthy eating choices [ Time Frame: 9 months post intervention ]
    Perceived efficacy to eat recommended number of servings of fruit and vegetables each day, avoid sugary drinks and eat breakfast daily

  17. 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

  18. Nutrition behavior timeframe [ Time Frame: 9 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

  19. Nutrition behavior about quantity of fruit consumed [ Time Frame: 3 months post intervention ]
    Amount (# of cups) of fruit consumed on a typical day

  20. Nutrition behavior about quantity of fruit consumed [ Time Frame: 9 months post intervention ]
    Amount (# of cups) of fruit consumed on a typical day

  21. Nutrition behavior about quantity of vegetables consumed [ Time Frame: 3 months post intervention ]
    Amount (# of cups) of vegetables consumed on a typical day

  22. Nutrition behavior about quantity of vegetables consumed [ Time Frame: 9 months post intervention ]
    Amount (# of cups) of vegetables consumed on a typical day

  23. 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

  24. Nutrition behavior about quantity of sweetened beverage consumed [ Time Frame: 9 months post intervention ]
    Amount (# of cups) of sweetened beverage consumed on a typical day

  25. 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

  26. Nutrition behavior about food information when dining out [ Time Frame: 9 months post intervention ]
    Notice or check nutrition information (on menu or online) when dining out

  27. Nutrition behavior about food information when shopping [ Time Frame: 3 months post intervention ]
    Notice or check nutrition information (food labels) when shopping

  28. Nutrition behavior about food information when shopping [ Time Frame: 9 months post intervention ]
    Notice or check nutrition information (food labels) when shopping



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993185


Contacts
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Contact: Amie Ashcraft, PhD, MPH 304-293-2321 amashcraft@hsc.wvu.edu
Contact: Anna Maria Berta, MS 412-268-6890 bertix@cmu.edu

Locations
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United States, Pennsylvania
Carnegie Mellon University Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Anna Maria Berta, MS    412-268-6890    bertix@cmu.edu   
Principal Investigator: Julie Downs, PhD         
Sponsors and Collaborators
Carnegie Mellon University
ETR Associates
Investigators
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Principal Investigator: Julie Downs, PhD Carnegie Mellon University
Principal Investigator: Pam Murray, MD, MHP West Virginia University

Publications of Results:
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Responsible Party: Julie Downs, Associate Research Professor, Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT02993185     History of Changes
Other Study ID Numbers: TP2AH000027
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Julie Downs, Carnegie Mellon University:
pregnancy
adolescents
sexually transmitted diseases
decision making
prevention education

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Pregnancy, Abdominal
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Pregnancy, Ectopic
Pregnancy Complications