Family Relationships and Nutrition in TGGD Youth and Young Adults

Health Behavior Clinical Trial

Official title:

Implications of Family Relationships on Nutrition and Health Behaviors in Transgender and Gender Diverse (TGGD) Youth and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163860
• Other study ID #: 31659
• Status: Completed
• Start date: December 27, 2021
• Est. completion date: February 27, 2022

Study information

• Verified date: March 2022
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess how family relationships are related to health and nutrition behaviors among transgender and gender diverse youth and young adults.

Description:

The study is recruiting the following populations: parents of transgender and gender diverse youth, transgender and gender diverse young adults, and transgender and gender diverse youth. Participants over the age of 18 will be recruited via Amazon Mechanical Turk (MTurk), and youth participants will be recruited via parent referral. Age and role-appropriate surveys will be administered to the three distinct populations. A waiver of written consent for participation will be used per survey protocol. After participants receive a recruitment statement about the study and the potential risks, willing participants will take a 10-20 minute survey to provide data regarding demographics, height and weight, food habits, physical activity, food security, health support, risk-taking behaviors, past health diagnoses, and family environment. No personal identifiers will be collected and all responses will remain confidential. Our main question is whether family acceptance of a transgender or gender diverse (TGGD) youth and young adults is related to health, nutrition, and risk-taking behaviors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: February 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

TGGD Young Adults:

• 18 to 25 years of age

• Self-identify as transgender or gender diverse

• A resident of the United States of America or Canada

• English speaking.

Parent of TGGD Youth

• A parent of a 12-17 year old TGGD youth

• A resident of the United States of America or Canada

• English speaking

• Have a child that self-identifies as transgender or gender diverse

TGGD Youth

• 12 to 17 years of age

• Self-identify as transgender or gender diverse

• A resident of the United States of America or Canada

• English speaking

Exclusion Criteria:

TGGD Young Adults

• Less than 18 years of age or greater than 25 years of age

• Self-identify as cis-gender

• Not a resident of the United States of America or Canada

• Non-english speaking

Parent of TGGD Youth:

• Parents of children that are less than 12 years of age or greater than 17 years of age

• Not a resident of the United States of America or Canada

• Non-english speaking

• Does not identify as a parent of a TGGD child

TGGD Youth

• Less than 12 years of age or greater than 17 years of age

• Does not self-identify as transgender or gender diverse

• Not a resident of the United States of America or Canada

• Non-english speaking

Related Conditions & MeSH terms

• Family Relations
• Health Behavior
• Nutrition Disorders
• Transgenderism

Intervention

Other:
• Survey
Participants will complete an online survey.

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Gender Environment measures of TGGD Youth, TGGD Young Adults, and Parents of TGGD Youth	For TGGD Youth, Young Adults, and Parents, the Family Gender Environment (FGE) questionnaire will measure family acceptance. The questionnaire has 3 parts. Part 1 has a minimum score of 0 and maximum of 57; high scores on part 1 indicate family acceptance. Part 2 has a minimum score of 0 and maximum of 60. A lower score for part 2 indicates greater family acceptance. Part 3 is scored with answers to questions 1, 3, and 6 with a combined minimum of 0 and maximum of 9; a lower score indicating higher family acceptance. Questions 2, 4, and 5 have a minimum of 0 and maximum of 9; a higher score indicating higher family acceptance.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Prevalence of Food Insecurity in TGGD Youth, TGGD Young Adults, and Parents of TGGD Youth	The Hunger Vital Sign (HVS) is a validated, 2 question screening tool. A response of "often true" or "sometimes true" to either or both questions indicates a positive screen for food insecurity.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Prevalence of Support of Healthy Eating and Physical Activity in TGGD Youth and TGGD Young Adults	The Support for Healthy Lifestyle (SheL) Family Questionnaire is a 20 question measure with 3 outcomes: Healthy Eating Support, Physical Activity Support, and Hypocritical Control. Each section has a minimum score of 0 and maximum score of 4. A higher calculated score indicates greater support for a healthy lifestyle. A higher total score indicates greater support.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Prevalence of Risk Taking Behavior in TGGD Youth and TGGD Young Adults	For TGGD Youth, risk taking behavior is measured with the Adolescent Risk Taking Questionnaire (ARQ), a 28-item measure. Participants rate their behaviors on a 5-point scale, 0-4. Minimum score of 0 and maximum score of 112. Responses are summed and greater scores reflect greater perceptions of risk and greater engagement in risky behavior.; For TGGD Young Adults, risk taking behavior is measured with the Risk and Reckless Behavior Questionnaire (RRBQ), an 18-item measure. Participants indicate frequency of engagement in behaviors in the last year, ranging from zero times to 100+ times. Scores are summed for a total score with higher numbers indicating greater risk taking behaviors.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Physical Activity Adequacy in TGGD Youth	The Patient-Centered Assessment and Counseling for Exercise plus Nutrition (PACE+) is a 2-item measure. Participants indicate the number of active days in a week with minimum 0 and maximum 7. The measure is scored by summing the responses. A score less than 5 indicates the participant is not meeting physical activity guidelines.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Body Mass Index of TGGD Youth and TGGD Young adults	Participants will respond with their height and weight, and their Body Mass Index (BMI) will be calculated (kg/m^2). Classification will be determined by Center for Disease Control guidelines for BMI. Underweight (less than 18.5), Normal (18.5-25), Overweight (25-<30), Obese (30+).	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Body Mass Index Percentile of TGGD Youth	Body Mass Index Percentile (BMI%ile) evaluates growth in youth age 2-20 years. It expresses BMI for age as a percentile obtained from the Center for Disease Control graph. https://www.cdc.gov/healthyweight/assessing/bmi/childrens_bmi/about_childrens_bmi.html#percentile Participants will respond with their height and weight, and their Body Mass Index (BMI) will be calculated (kg/m^2). Classification will be determined by CDC guidelines; <5th %ile underweight, 5-85th %ile healthy, 85-95th %ile overweight, equal to or over 95th %ile obese.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Percent Median Body Mass Index for TGGD Youth	Percent Median Body Mass Index (%mBMI) is used as a comparative standard for BMI of youth age 10-19. https://www.who.int/data/gho/data/indicators/indicator-details/GHO/prevalence-of-overweight-among-children-and-adolescents-bmi-1-standard-deviations-above-the-median-(crude-estimate)-(-); %mBMI is calculated by comparing the BMI of the child to the median BMI for children their age, regardless of gender.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Malnutrition Risk in TGGD Young Adults	The Malnutrition Screening Tool (MST) is a 3-item measure that screens for malnutrition. Minimum value is 0 and maximum is 7. A score of 0-1 indicates no risk for malnutrition, and a score of 2 or more indicates risk for malnutrition.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Eating Disorder Risk in TGGD Youth and Young Adults	For TDDG Youth, a "yes" response to previously diagnosed eating disorder question indicates an eating disorder. The Adolescent Binge Eating Disorder Questionnaire (ADO-BED); min value 0 and max 10. High scores indicate increased risk. Positive answers to questions 1 or 2 with 6 or more positive answers to additional questions are high risk. Participants with 3 or less positive answers are low risk.; For TGGD Young Adults, a "yes" response to previously diagnosed eating disorder question indicates an eating disorder. The Adolescent Binge Eating Disorder Questionnaire (ADO-BED) minimum value is 0 and maximum value is 10. Higher scores indicate increased risk. Positive answers to questions 1 or 2 and 6 or more positive answers to the 8 additional questions are high risk. 3 or less positive answers are low risk. The Sick, Control, One, Fat, Food, (SCOFF) Questionnaire; minimum value of 0 and maximum value of 5. A score 2 indicates a likely anorexia nervosa or bulimia nervosa.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Prevalence of Anxiety in Parents of TGGD Youth	The Generalized Anxiety Disorder-7 Questionnaire (GAD-7) total score for the 7 items ranges from 0-21. 0-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Prevalence of Depression in Parents of TGGD Youth	The Patient Health Questionnaire (PHQ-9) screens for severity of depression. The 9 item measure has selections from 0 "not at all" to 3 "nearly every day" and a total minimum score of 0 and maximum score of 27. Higher PHQ scores are associated with decreased functional states and increased symptom-related difficulties.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Prevalence of Psychiatric and Neurodevelopmental Disorders in TGGD Young Adults	Describe prevalence of neurological disorders in the population by having the participants select previous diagnoses from a list of conditions.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Compare Parent and Youth Reports of Family Environment, Food Insecurity, and Weight	Compare reports of family environment (FGE), food insecurity (HVS), and weight (BMI%ile, BMI, %mBMI) between parents of TGGD youth and TGGD youth.	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	Parent of TGGD Youth Demographics	Describe the parent of TGGD youth sample with data on demographics (religion, degree of religiosity, degree of conservatism/liberalism, country of residence, ethnicity, gender identity, sex assigned at birth, sexual orientation, education, marital status, household size, income).	10-20 minute survey completed at one point within the 1 month recruitment period.
Primary	TGGD Youth and TGGD Young Adult Demographics	Describe the TGGD youth and TGGD young adult sample with data on demographics (gender identity, sex assigned at birth, country of residence, ethnicity, age, religion, degree of religiosity, degree of family religiosity, degree of conservatism/liberalism).	10-20 minute survey completed at one point within the 1 month recruitment period.