<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03037502</url>
  </required_header>
  <id_info>
    <org_study_id>160108</org_study_id>
    <secondary_id>1U54MD010722</secondary_id>
    <nct_id>NCT03037502</nct_id>
    <nct_alias>NCT04040335</nct_alias>
  </id_info>
  <brief_title>Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men</brief_title>
  <official_title>Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Meharry Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      If the investigators are to adequately address the health needs of African American and&#xD;
      Latino men, both culture and gender must be considered when developing and implementing&#xD;
      strategies to encourage weight loss and increase their healthy eating and physical&#xD;
      activity.The aim of this project is to develop and test gendered, culturally and contextually&#xD;
      relevant messages that will be used in a future, web- based tailored intervention to&#xD;
      encourage healthy eating and physical activity in African American and Latino men. This study&#xD;
      is part of a larger research agenda that for a decade has focused on understanding and&#xD;
      reducing chronic disease risk among African American and Latino men. Because men are more&#xD;
      likely than women to engage in over 30 behaviors known to increase their risk of injury,&#xD;
      morbidity, and mortality, improving men's health requires understanding the social and&#xD;
      cultural factors that help explain sex differences in health. Operationalizing gender in&#xD;
      individually-tailored health communications has great potential to unlock the potential of&#xD;
      health communications and interventions to engage and improve the health of men and&#xD;
      particularly African American and Latino men. To date, no community-based intervention has&#xD;
      produced clinically significant improvements in weight loss, healthy eating or physical&#xD;
      activity in Latino and African American men. It also is unclear how technology can be used to&#xD;
      promote these behaviors in this population. Thus, there is a need to develop healthy eating,&#xD;
      physical activity and weight loss interventions specifically targeted and tailored to African&#xD;
      American and Latino men that explores the utility of technology. This intervention content&#xD;
      and focus represents a novel strategy to promote health equity by using technology-based&#xD;
      health care innovations to improve healthy eating and active living by addressing a root&#xD;
      cause of unhealthy behavior in men: notions of manhood. The investigators focus on gender and&#xD;
      manhood because they are under-explored factors that shape men's health behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall aim of this study is to develop and pilot an individualized weight-loss&#xD;
      intervention for obese middle-aged African American and Latino men and to explore how the&#xD;
      genetically predicted BMI relates to outcomes. Using strategies previously employed by the PI&#xD;
      to develop individually-tailored materials for African American men, the proposed study is&#xD;
      designed to develop person-specific materials for Latino men (Specific Aim 1). Investigators&#xD;
      also will pilot a behavioral weight loss intervention for 35-64 year old African American men&#xD;
      in Nashville and Latino men in Miami (Specific Aims 2-3), and explore how the phenotypic&#xD;
      expression of obesity shapes and is affected by behavioral and physiological changes&#xD;
      (Specific Aim 4). The proposed intervention includes (a) person-specific goals/ messages (via&#xD;
      web and text), (b) self-monitoring (via wearable device and text), (c) small group training&#xD;
      and education (including social support) and (d) educational and community-based information&#xD;
      and resources (via web and text).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2019</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in weight at 3-months post-baseline</measure>
    <time_frame>3-months post-baseline of participation</time_frame>
    <description>Investigators will report weight change in absolute terms from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change in weight at 3-months post-baseline</measure>
    <time_frame>3-months post-baseline of participation</time_frame>
    <description>Investigators will report weight change as percent change from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight classification</measure>
    <time_frame>3-months post baseline of participation</time_frame>
    <description>Investigators will assess change in percentage of participants that regress from obese to overweight classification using BMI in kg/m^2.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in eating practices measured by the Food, Attitudes, and Behaviors Survey (FAB)</measure>
    <time_frame>3-months post baseline of participation</time_frame>
    <description>As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, to measure the change in fruit and vegetable intake (FVI) during the past month. Responses will be converted into servings, as defined by the MyPyramid 1992 dietary guidelines. Total FVI was calculated as the sum of all items on the screener, excluding fried potatoes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in physical activity measured by the Global Physical Activity Questionnaire (GPAQ)</measure>
    <time_frame>3-months post baseline of participation</time_frame>
    <description>The GPAQ measures time spent in vigorous and moderate intensity physical activity. A higher score equates to more physical activity. The range is from 0 - 150 minutes per week.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Weight Loss</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Intervention: Tailor Made</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention Arm: In the pilot intervention, participants will receive: tailored goals/ messages, self-monitoring, weekly small groups to receive health education and community-based information and resources. Participants will also complete two assessment with blood work and anthropometric measurements. These intervention components were selected based on investigator's formative research and experience using them in prior studies. These components will be implemented simultaneously as they complement one another. While all of these components have not been tested together in an intervention for this population, they are variations and enhancements of previous interventions by the investigators.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Comparison Condition: Participants in the attention control group will receive self-help materials on how to improve healthy eating, physical activity and weight loss, self-monitoring, and complete two assessments with blood work and anthropometric measurements. Participants in this condition will receive a copy of their assessment data and the nurses will provide this personalized information as well as answer any questions participants may have about their assessment results.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)</intervention_name>
    <description>Assess the effectiveness of a person-specific, randomized controlled pilot weight loss study of 80 African American and 40 Latino men; to compare changes in chronic disease risk behaviors (e.g., diet and physical activity), adiposity measures (e.g., body fat), and psychosocial mediators (e.g., social support, autonomous motivation) between data collected at baseline and at 3-months.</description>
    <arm_group_label>Intervention: Tailor Made</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 35-64 at enrollment&#xD;
&#xD;
          -  Race/ ethnicity: African American/ Black or Latino/ Hispanic&#xD;
&#xD;
          -  BMI: 27-50&#xD;
&#xD;
          -  Fluent in English (Nashville and Miami) or Spanish (Miami)&#xD;
&#xD;
          -  Provide informed consent&#xD;
&#xD;
          -  Weight less than 400 pounds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preexisting condition that prohibits at least moderate physical activity&#xD;
&#xD;
          -  Serious medical condition that is likely to hinder accurate measurement of weight, for&#xD;
             which weight loss is contraindicated or that would cause weight loss&#xD;
&#xD;
          -  Prior or planned bariatric surgery&#xD;
&#xD;
          -  Chronic use of medications that are likely to cause weight gain or cause weight loss&#xD;
&#xD;
          -  No cell phone or land-line phone&#xD;
&#xD;
          -  Participant in another obesity, eating or physical activity program or study&#xD;
&#xD;
          -  Psychiatric hospitalization or in-patient substance abuse treatment in the last 12&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This study is interested in piloting a tailored health promoting intervention for African American and Latino men. Thus, recruitment will be open to individuals who self-identify as African American or Latino men, ages 35-64 at enrollment.</gender_description>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily C Jaeger, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Derek M Griffith, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Natasha Solle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neysari Arana, MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Griffith DM, Jaeger EC, Valdez LA, Schaefer Solle N, Garcia DO, Alexander LR. Developing a &quot;Tailor-Made&quot; Precision Lifestyle Medicine Intervention for Weight Control among Middle-aged Latino Men. Ethn Dis. 2020 Apr 2;30(Suppl 1):203-210. doi: 10.18865/ed.30.S1.203. eCollection 2020.</citation>
    <PMID>32269462</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Derek Griffith</investigator_full_name>
    <investigator_title>Director of the Center for Research on Men's Health</investigator_title>
  </responsible_party>
  <keyword>Men's Health</keyword>
  <keyword>weight loss</keyword>
  <keyword>African American men</keyword>
  <keyword>Latino men</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03037502/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037502
org study id: 160108
secondary id: 1U54MD010722
nct id: NCT03037502
nct alias: NCT04040335
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
If the investigators are to adequately address the health needs of African American and
      Latino men, both culture and gender must be considered when developing and implementing
      strategies to encourage weight loss and increase their healthy eating and physical
      activity.The aim of this project is to develop and test gendered, culturally and contextually
      relevant messages that will be used in a future, web- based tailored intervention to
      encourage healthy eating and physical activity in African American and Latino men. This study
      is part of a larger research agenda that for a decade has focused on understanding and
      reducing chronic disease risk among African American and Latino men. Because men are more
      likely than women to engage in over 30 behaviors known to increase their risk of injury,
      morbidity, and mortality, improving men's health requires understanding the social and
      cultural factors that help explain sex differences in health. Operationalizing gender in
      individually-tailored health communications has great potential to unlock the potential of
      health communications and interventions to engage and improve the health of men and
      particularly African American and Latino men. To date, no community-based intervention has
      produced clinically significant improvements in weight loss, healthy eating or physical
      activity in Latino and African American men. It also is unclear how technology can be used to
      promote these behaviors in this population. Thus, there is a need to develop healthy eating,
      physical activity and weight loss interventions specifically targeted and tailored to African
      American and Latino men that explores the utility of technology. This intervention content
      and focus represents a novel strategy to promote health equity by using technology-based
      health care innovations to improve healthy eating and active living by addressing a root
      cause of unhealthy behavior in men: notions of manhood. The investigators focus on gender and
      manhood because they are under-explored factors that shape men's health behaviors.
The overall aim of this study is to develop and pilot an individualized weight-loss
      intervention for obese middle-aged African American and Latino men and to explore how the
      genetically predicted BMI relates to outcomes. Using strategies previously employed by the PI
      to develop individually-tailored materials for African American men, the proposed study is
      designed to develop person-specific materials for Latino men (Specific Aim 1). Investigators
      also will pilot a behavioral weight loss intervention for 35-64 year old African American men
      in Nashville and Latino men in Miami (Specific Aims 2-3), and explore how the phenotypic
      expression of obesity shapes and is affected by behavioral and physiological changes
      (Specific Aim 4). The proposed intervention includes (a) person-specific goals/ messages (via
      web and text), (b) self-monitoring (via wearable device and text), (c) small group training
      and education (including social support) and (d) educational and community-based information
      and resources (via web and text).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in weight at 3-months post-baseline
time frame: 3-months post-baseline of participation
description: Investigators will report weight change in absolute terms from baseline.
measure: Percent change in weight at 3-months post-baseline
time frame: 3-months post-baseline of participation
description: Investigators will report weight change as percent change from baseline.
measure: Change in weight classification
time frame: 3-months post baseline of participation
description: Investigators will assess change in percentage of participants that regress from obese to overweight classification using BMI in kg/m^2.
measure: Change in eating practices measured by the Food, Attitudes, and Behaviors Survey (FAB)
time frame: 3-months post baseline of participation
description: As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, to measure the change in fruit and vegetable intake (FVI) during the past month. Responses will be converted into servings, as defined by the MyPyramid 1992 dietary guidelines. Total FVI was calculated as the sum of all items on the screener, excluding fried potatoes.
measure: Change in physical activity measured by the Global Physical Activity Questionnaire (GPAQ)
time frame: 3-months post baseline of participation
description: The GPAQ measures time spent in vigorous and moderate intensity physical activity. A higher score equates to more physical activity. The range is from 0 - 150 minutes per week.
arm group label: Intervention: Tailor Made
arm group type: Experimental
description: Intervention Arm: In the pilot intervention, participants will receive: tailored goals/ messages, self-monitoring, weekly small groups to receive health education and community-based information and resources. Participants will also complete two assessment with blood work and anthropometric measurements. These intervention components were selected based on investigator's formative research and experience using them in prior studies. These components will be implemented simultaneously as they complement one another. While all of these components have not been tested together in an intervention for this population, they are variations and enhancements of previous interventions by the investigators.
arm group label: Comparison
arm group type: No Intervention
description: Comparison Condition: Participants in the attention control group will receive self-help materials on how to improve healthy eating, physical activity and weight loss, self-monitoring, and complete two assessments with blood work and anthropometric measurements. Participants in this condition will receive a copy of their assessment data and the nurses will provide this personalized information as well as answer any questions participants may have about their assessment results.
intervention type: Behavioral
intervention name: Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)
description: Assess the effectiveness of a person-specific, randomized controlled pilot weight loss study of 80 African American and 40 Latino men; to compare changes in chronic disease risk behaviors (e.g., diet and physical activity), adiposity measures (e.g., body fat), and psychosocial mediators (e.g., social support, autonomous motivation) between data collected at baseline and at 3-months.
arm group label: Intervention: Tailor Made
criteria: 
gender: Male
gender based: Yes
gender description: This study is interested in piloting a tailored health promoting intervention for African American and Latino men. Thus, recruitment will be open to individuals who self-identify as African American or Latino men, ages 35-64 at enrollment.
minimum age: 35 Years
maximum age: 64 Years
healthy volunteers: No
last name: Emily C Jaeger, MPH
role: Study Director
affiliation: Vanderbilt University
last name: Derek M Griffith, PhD
role: Principal Investigator
affiliation: Vanderbilt University
last name: Natasha Solle, PhD
role: Principal Investigator
affiliation: University of Miami
last name: Neysari Arana, MPH
role: Study Director
affiliation: University of Miami
facility: 
facility: 
country: United States
citation: Griffith DM, Jaeger EC, Valdez LA, Schaefer Solle N, Garcia DO, Alexander LR. Developing a "Tailor-Made" Precision Lifestyle Medicine Intervention for Weight Control among Middle-aged Latino Men. Ethn Dis. 2020 Apr 2;30(Suppl 1):203-210. doi: 10.18865/ed.30.S1.203. eCollection 2020.
PMID: 32269462
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Derek Griffith
investigator title: Director of the Center for Research on Men's Health
mesh term: Obesity
mesh term: Weight Loss
sharing ipd: No
provided document: 