<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/NCT02205697</url>
  </required_header>
  <id_info>
    <org_study_id>mdh-32828</org_study_id>
    <nct_id>NCT02205697</nct_id>
  </id_info>
  <brief_title>Theory of Planned Behavior and Implementation Intentions</brief_title>
  <acronym>TPBIIFV</acronym>
  <official_title>Theory of Planned Behavior and Implementation Intentions: Effective for Improving Fruit and Vegetable Intake in Women of Low Socioeconomic Status?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diet quality has been associated with a variety of chronic diseases including obesity. One&#xD;
      measure that has been studied as an indicator for diet quality is fruit and vegetable intake.&#xD;
      Although the US government has suggested that American's increase their intake of fruit and&#xD;
      vegetables, epidemiological data suggest that most Americans have not been successful doing&#xD;
      do, with the strongest disparity seen in people of low socioeconomic status (SES). This&#xD;
      disparity in fruit and vegetable intake is thought to be the result of both individual and&#xD;
      environmental factors that influence this health behavior. To help decrease the disparate&#xD;
      rise in incidence of chronic disease in people of low SES, effective, cost-efficient and easy&#xD;
      to implement interventions to improve fruit and vegetable intake and diet quality are needed.&#xD;
&#xD;
      Theoretical models of health behavior change have been successfully used in research&#xD;
      targeting individual factors associated with health behaviors. One theory, the Theory of&#xD;
      Planned Behavior (TPB), and a proposed extension of this model (implementation intentions)&#xD;
      have been shown to be effective to increase fruit and vegetable intake in (mostly) white&#xD;
      adults of average socioeconomic status. It is not know whether an implementation intention&#xD;
      intervention to increase fruit and vegetable intake would be effective in women who are of&#xD;
      low socioeconomic status. The primary aim of this research is to study (using quantitative&#xD;
      and qualitative analysis) an implementation intention intervention to produce a positive&#xD;
      change in fruit and vegetable intake. We theorize that the setting of an implementation&#xD;
      intention in this group will be effective, cost-effective, and easy to implement intervention&#xD;
      to promote an increase in fruit and vegetable intake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Theory of Planned Behavior Variables (attitude, perceived behavioral control, intention)&#xD;
      measured via survey using 1 question each, bivariate semantic differential scale.&#xD;
&#xD;
      Main outcomes measure is fruit and vegetable intake. Behavioral Risk Factor Surveillance&#xD;
      System Fruit and Vegetable Module (6-item screener) + pictorial of serving sizes.&#xD;
&#xD;
      Demographic data measured via survey. Height measured via tape measure. Weight measured using&#xD;
      a standing scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean intake of fruit and vegetables (servings per day) both within and between the experimental and control groups.</measure>
    <time_frame>30 days</time_frame>
    <description>Change in mean intake of fruit and vegetables (servings per day) will be assessed in both the experimental and control groups using the Behavioral Risk Factor Surveillance System (BRFSS) Fruit and Vegetable Module. Inferential statistics will be used to assess differences in change in mean fruit and vegetable intake both within and between groups.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>Implementation intention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The entire cohort will be asked to create an implementation intention to increase their intake of fruit and vegetables over the study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Implementation intention</intervention_name>
    <description>The intervention consists of an implementation intention whereby subjects create a unique plan to increase their fruit and vegetable intake by planning the where, when, and what to increase their fruit and vegetable intake.</description>
    <arm_group_label>Implementation intention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident of Boston Public Housing&#xD;
&#xD;
          -  Identifies as female&#xD;
&#xD;
          -  Age 18-72&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Agrees to be randomized into either the intervention or the control groups&#xD;
&#xD;
          -  Understands English sufficient to comprehend purpose, risks, benefits and voluntary&#xD;
             nature of the study, and to complete the surveys and provide information in this&#xD;
             language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not consent to study participation&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Identifies as following a strict medically prescribed diet, as having an allergy to&#xD;
             fruit and/or vegetables, or as currently taking medications that necessitate the&#xD;
             avoidance or reduction of fruit and/or vegetable intake.&#xD;
&#xD;
          -  Does not agree to be randomized into either the intervention or control groups&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele A DeBiasse, MS, RDN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University/Graduate Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University School of Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>January 15, 2016</last_update_submitted>
  <last_update_submitted_qc>January 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fruit</keyword>
  <keyword>Vegetable</keyword>
  <!-- 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/NCT02205697
org study id: mdh-32828
nct id: NCT02205697
lead sponsor: 
has dmc: No
Diet quality has been associated with a variety of chronic diseases including obesity. One
      measure that has been studied as an indicator for diet quality is fruit and vegetable intake.
      Although the US government has suggested that American's increase their intake of fruit and
      vegetables, epidemiological data suggest that most Americans have not been successful doing
      do, with the strongest disparity seen in people of low socioeconomic status (SES). This
      disparity in fruit and vegetable intake is thought to be the result of both individual and
      environmental factors that influence this health behavior. To help decrease the disparate
      rise in incidence of chronic disease in people of low SES, effective, cost-efficient and easy
      to implement interventions to improve fruit and vegetable intake and diet quality are needed.

      Theoretical models of health behavior change have been successfully used in research
      targeting individual factors associated with health behaviors. One theory, the Theory of
      Planned Behavior (TPB), and a proposed extension of this model (implementation intentions)
      have been shown to be effective to increase fruit and vegetable intake in (mostly) white
      adults of average socioeconomic status. It is not know whether an implementation intention
      intervention to increase fruit and vegetable intake would be effective in women who are of
      low socioeconomic status. The primary aim of this research is to study (using quantitative
      and qualitative analysis) an implementation intention intervention to produce a positive
      change in fruit and vegetable intake. We theorize that the setting of an implementation
      intention in this group will be effective, cost-effective, and easy to implement intervention
      to promote an increase in fruit and vegetable intake.
Theory of Planned Behavior Variables (attitude, perceived behavioral control, intention)
      measured via survey using 1 question each, bivariate semantic differential scale.

      Main outcomes measure is fruit and vegetable intake. Behavioral Risk Factor Surveillance
      System Fruit and Vegetable Module (6-item screener) + pictorial of serving sizes.

      Demographic data measured via survey. Height measured via tape measure. Weight measured using
      a standing scale.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Change in mean intake of fruit and vegetables (servings per day) both within and between the experimental and control groups.
time frame: 30 days
description: Change in mean intake of fruit and vegetables (servings per day) will be assessed in both the experimental and control groups using the Behavioral Risk Factor Surveillance System (BRFSS) Fruit and Vegetable Module. Inferential statistics will be used to assess differences in change in mean fruit and vegetable intake both within and between groups.
arm group label: Implementation intention
arm group type: Experimental
description: The entire cohort will be asked to create an implementation intention to increase their intake of fruit and vegetables over the study period.
intervention type: Behavioral
intervention name: Implementation intention
description: The intervention consists of an implementation intention whereby subjects create a unique plan to increase their fruit and vegetable intake by planning the where, when, and what to increase their fruit and vegetable intake.
arm group label: Implementation intention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 72 Years
healthy volunteers: No
last name: Michele A DeBiasse, MS, RDN
role: Principal Investigator
affiliation: Boston University/Graduate Medical Sciences
facility: 
country: United States
responsible party type: Sponsor