<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/NCT02253641</url>
  </required_header>
  <id_info>
    <org_study_id>14-2107</org_study_id>
    <nct_id>NCT02253641</nct_id>
  </id_info>
  <brief_title>The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits</brief_title>
  <official_title>The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academy of Nutrition and Dietetics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy of a stress-focused tailored weight loss intervention&#xD;
      compared to a standard weight loss intervention on weight loss in severely obese (BMI &gt; 40.0)&#xD;
      African American women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stress has been identified as a major barrier to engaging in healthy lifestyle behaviors&#xD;
      (e.g. diet and exercise) among African American women. African American women consistently&#xD;
      lose less weight than their Caucasian counterparts in weight loss interventions. One reason&#xD;
      for this disparity may be due to the failure of most weight loss interventions to address&#xD;
      stress management adequately or in a culturally competent way.&#xD;
&#xD;
      The purpose of this study is to evaluate the efficacy of a stress-focused tailored weight&#xD;
      loss intervention compared to a standard weight loss intervention on weight loss in severely&#xD;
      obese (BMI &gt; 40.0) African American women. The stress-focused weight loss intervention will&#xD;
      incorporate stress management content throughout the entire intervention and will include&#xD;
      content that is culturally tailored. The standard weight loss intervention will cover stress&#xD;
      management techniques during one of the 14 sessions and the material will be more generic in&#xD;
      nature (e.g. not culturally tailored).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>Change from Baseline to 6 Months</time_frame>
    <description>collect weight in pounds</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Change from Baseline to 6 Months</time_frame>
    <description>participants will wear accelerometer for 1 week at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial &amp; Behavioral Measures</measure>
    <time_frame>Change from Baseline to 6 Months</time_frame>
    <description>Participants will complete a survey that will assess varying psychosocial and behavioral measures including: (1) diet and exercise habits, (2) stress levels, (3) moods and (4) attitudes and beliefs regarding female stereotypes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walkability</measure>
    <time_frame>Change from Baseline to 6 Months</time_frame>
    <description>Stand Up and Go Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aerobic Fitness</measure>
    <time_frame>Change from Baseline to 6 Months</time_frame>
    <description>6 Minute Walk Test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Standard Weight Loss Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will take part in a 14 session weight loss/healthy lifestyle intervention. Sessions will be 2 hours in length and will occur weekly for month 1 then bi-weekly for months 2 - 6. The core lifestyle curriculum content for both groups will come from the previously IRB-approved Weight Wise intervention developed by Samuel-Hodge et al. (Samuel-Hodge, Carmen D., et al. &quot;Randomized Trial of a Behavioral Weight Loss Intervention for Low?income Women: The Weight Wise Program.&quot; Obesity 17.10 (2009): 1891-1899). The only modifications to the content (other than some general formatting) will be the combining of sessions 3 and 4 and sessions 6 and 7. These changes will allow us to fit the original 16-session curriculum into the 14-session format of our intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stress-Focused Weight Loss Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take part in a 14 session weight loss/healthy lifestyle intervention. Sessions will be 2 hours in length and will occur weekly for month 1 then bi-weekly for months 2 - 6. The core lifestyle curriculum content for both groups will come from the previously IRB-approved Weight Wise intervention developed by Samuel-Hodge et al.. The participants in this arm will receive all of the content that the comparison group receives (just moderately condensed to allow time for additional components) plus a stress-reduction intervention woven into each of the sessions. The stress-reduction content aims to reduce stress by helping participants: (1) identifying and reducing exposure (to the degree possible) of current stressors, (2) change their perceptions of current stressors and (3) use healthier stress-coping techniques (e.g. yoga, meditation, etc.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Weight Loss Intervention</intervention_name>
    <description>14-session/6-month standard behavioral weight loss intervention</description>
    <arm_group_label>Standard Weight Loss Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stress-Focused Weight Loss Intervention</intervention_name>
    <description>14-session/6-month tailored behavioral weight loss intervention</description>
    <arm_group_label>Stress-Focused Weight Loss Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  African American (self-identified)&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  BMI &gt; 40 kg/m2&#xD;
&#xD;
          -  Access to internet connection and phone for personal use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to walk without the use of an assistance device&#xD;
&#xD;
          -  Failure to pass the Physical Activity Readiness Questionnaire (PAR-Q) or unable to&#xD;
             attain medical clearance from their doctor&#xD;
&#xD;
          -  Substance abuse within past two years&#xD;
&#xD;
          -  Schizophrenia&#xD;
&#xD;
          -  Currently pregnant, pregnant within the past 6 months or plans to become pregnant in&#xD;
             the next 6 months&#xD;
&#xD;
          -  History of malignancy other than non-melanoma skin cancer, that has not been in&#xD;
             remission or cured surgically for &gt; 5 years&#xD;
&#xD;
          -  Participation in a weight loss program in the past 12 months&#xD;
&#xD;
          -  &gt; 5% loss of body weight within the past 6 months&#xD;
&#xD;
          -  Bariatric surgery recipient&#xD;
&#xD;
          -  Heart attack in the past 6 months&#xD;
&#xD;
          -  Stroke within the past 6 months&#xD;
&#xD;
        NOTE: Participants who &quot;fail&quot; the PAR-Q will be required to obtain medical clearance from&#xD;
        their medical provider&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UNC Center for Health Promotion and Disease Prevention</name>
      <address>
        <city>Chapel-Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fitzgerald KR. Review of article: Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010 by Katherine M. Flegal, PhD; Margaret D. Carroll, MSPH; Brian K. Kit, MD; Cynthia L. Ogden, PhD (JAMA 2012;307:491-7). J Vasc Nurs. 2013 Sep;31(3):131-2. doi: 10.1016/j.jvn.2013.06.004. No abstract available.</citation>
    <PMID>23953862</PMID>
  </reference>
  <reference>
    <citation>Goodpaster BH, Delany JP, Otto AD, Kuller L, Vockley J, South-Paul JE, Thomas SB, Brown J, McTigue K, Hames KC, Lang W, Jakicic JM. Effects of diet and physical activity interventions on weight loss and cardiometabolic risk factors in severely obese adults: a randomized trial. JAMA. 2010 Oct 27;304(16):1795-802. doi: 10.1001/jama.2010.1505. Epub 2010 Oct 9.</citation>
    <PMID>20935337</PMID>
  </reference>
  <reference>
    <citation>Ryan DH, Johnson WD, Myers VH, Prather TL, McGlone MM, Rood J, Brantley PJ, Bray GA, Gupta AK, Broussard AP, Barootes BG, Elkins BL, Gaudin DE, Savory RL, Brock RD, Datz G, Pothakamuri SR, McKnight GT, Stenlof K, Sjostrom LV. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med. 2010 Jan 25;170(2):146-54. doi: 10.1001/archinternmed.2009.508.</citation>
    <PMID>20101009</PMID>
  </reference>
  <reference>
    <citation>West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and women in the Diabetes Prevention Program. Obesity (Silver Spring). 2008 Jun;16(6):1413-20. doi: 10.1038/oby.2008.224. Epub 2008 Apr 10. Erratum In: Obesity (Silver Spring). 2009 Nov;17(11):2119-20.</citation>
    <PMID>18421273</PMID>
  </reference>
  <reference>
    <citation>Cox TL, Krukowski R, Love SJ, Eddings K, DiCarlo M, Chang JY, Prewitt TE, West DS. Stress management-augmented behavioral weight loss intervention for African American women: a pilot, randomized controlled trial. Health Educ Behav. 2013 Feb;40(1):78-87. doi: 10.1177/1090198112439411. Epub 2012 Apr 13.</citation>
    <PMID>22505570</PMID>
  </reference>
  <reference>
    <citation>Samuel-Hodge CD, Headen SW, Skelly AH, Ingram AF, Keyserling TC, Jackson EJ, Ammerman AS, Elasy TA. Influences on day-to-day self-management of type 2 diabetes among African-American women: spirituality, the multi-caregiver role, and other social context factors. Diabetes Care. 2000 Jul;23(7):928-33. doi: 10.2337/diacare.23.7.928.</citation>
    <PMID>10895842</PMID>
  </reference>
  <reference>
    <citation>Fitzgibbon ML, Tussing-Humphreys LM, Porter JS, Martin IK, Odoms-Young A, Sharp LK. Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature. Obes Rev. 2012 Mar;13(3):193-213. doi: 10.1111/j.1467-789X.2011.00945.x. Epub 2011 Nov 10.</citation>
    <PMID>22074195</PMID>
  </reference>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 20, 2015</last_update_submitted>
  <last_update_submitted_qc>September 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>Danielle Braxton, MPH, RD</investigator_full_name>
    <investigator_title>Graduate Research Assistant</investigator_title>
  </responsible_party>
  <keyword>African American, Women</keyword>
  <keyword>Weight Loss</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/NCT02253641
org study id: 14-2107
nct id: NCT02253641
lead sponsor: 
collaborator: 
has dmc: No
This study evaluates the efficacy of a stress-focused tailored weight loss intervention
      compared to a standard weight loss intervention on weight loss in severely obese (BMI > 40.0)
      African American women.
Stress has been identified as a major barrier to engaging in healthy lifestyle behaviors
      (e.g. diet and exercise) among African American women. African American women consistently
      lose less weight than their Caucasian counterparts in weight loss interventions. One reason
      for this disparity may be due to the failure of most weight loss interventions to address
      stress management adequately or in a culturally competent way.

      The purpose of this study is to evaluate the efficacy of a stress-focused tailored weight
      loss intervention compared to a standard weight loss intervention on weight loss in severely
      obese (BMI > 40.0) African American women. The stress-focused weight loss intervention will
      incorporate stress management content throughout the entire intervention and will include
      content that is culturally tailored. The standard weight loss intervention will cover stress
      management techniques during one of the 14 sessions and the material will be more generic in
      nature (e.g. not culturally tailored).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Weight
time frame: Change from Baseline to 6 Months
description: collect weight in pounds
measure: Physical Activity
time frame: Change from Baseline to 6 Months
description: participants will wear accelerometer for 1 week at each time point
measure: Psychosocial & Behavioral Measures
time frame: Change from Baseline to 6 Months
description: Participants will complete a survey that will assess varying psychosocial and behavioral measures including: (1) diet and exercise habits, (2) stress levels, (3) moods and (4) attitudes and beliefs regarding female stereotypes.
measure: Walkability
time frame: Change from Baseline to 6 Months
description: Stand Up and Go Test
measure: Aerobic Fitness
time frame: Change from Baseline to 6 Months
description: 6 Minute Walk Test
arm group label: Standard Weight Loss Intervention
arm group type: Active Comparator
description: Participants will take part in a 14 session weight loss/healthy lifestyle intervention. Sessions will be 2 hours in length and will occur weekly for month 1 then bi-weekly for months 2 - 6. The core lifestyle curriculum content for both groups will come from the previously IRB-approved Weight Wise intervention developed by Samuel-Hodge et al. (Samuel-Hodge, Carmen D., et al. "Randomized Trial of a Behavioral Weight Loss Intervention for Low?income Women: The Weight Wise Program." Obesity 17.10 (2009): 1891-1899). The only modifications to the content (other than some general formatting) will be the combining of sessions 3 and 4 and sessions 6 and 7. These changes will allow us to fit the original 16-session curriculum into the 14-session format of our intervention.
arm group label: Stress-Focused Weight Loss Intervention
arm group type: Experimental
description: Participants will take part in a 14 session weight loss/healthy lifestyle intervention. Sessions will be 2 hours in length and will occur weekly for month 1 then bi-weekly for months 2 - 6. The core lifestyle curriculum content for both groups will come from the previously IRB-approved Weight Wise intervention developed by Samuel-Hodge et al.. The participants in this arm will receive all of the content that the comparison group receives (just moderately condensed to allow time for additional components) plus a stress-reduction intervention woven into each of the sessions. The stress-reduction content aims to reduce stress by helping participants: (1) identifying and reducing exposure (to the degree possible) of current stressors, (2) change their perceptions of current stressors and (3) use healthier stress-coping techniques (e.g. yoga, meditation, etc.)
intervention type: Behavioral
intervention name: Standard Weight Loss Intervention
description: 14-session/6-month standard behavioral weight loss intervention
arm group label: Standard Weight Loss Intervention
intervention type: Behavioral
intervention name: Stress-Focused Weight Loss Intervention
description: 14-session/6-month tailored behavioral weight loss intervention
arm group label: Stress-Focused Weight Loss Intervention
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Fitzgerald KR. Review of article: Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010 by Katherine M. Flegal, PhD; Margaret D. Carroll, MSPH; Brian K. Kit, MD; Cynthia L. Ogden, PhD (JAMA 2012;307:491-7). J Vasc Nurs. 2013 Sep;31(3):131-2. doi: 10.1016/j.jvn.2013.06.004. No abstract available.
PMID: 23953862
citation: Goodpaster BH, Delany JP, Otto AD, Kuller L, Vockley J, South-Paul JE, Thomas SB, Brown J, McTigue K, Hames KC, Lang W, Jakicic JM. Effects of diet and physical activity interventions on weight loss and cardiometabolic risk factors in severely obese adults: a randomized trial. JAMA. 2010 Oct 27;304(16):1795-802. doi: 10.1001/jama.2010.1505. Epub 2010 Oct 9.
PMID: 20935337
citation: Ryan DH, Johnson WD, Myers VH, Prather TL, McGlone MM, Rood J, Brantley PJ, Bray GA, Gupta AK, Broussard AP, Barootes BG, Elkins BL, Gaudin DE, Savory RL, Brock RD, Datz G, Pothakamuri SR, McKnight GT, Stenlof K, Sjostrom LV. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med. 2010 Jan 25;170(2):146-54. doi: 10.1001/archinternmed.2009.508.
PMID: 20101009
citation: West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and women in the Diabetes Prevention Program. Obesity (Silver Spring). 2008 Jun;16(6):1413-20. doi: 10.1038/oby.2008.224. Epub 2008 Apr 10. Erratum In: Obesity (Silver Spring). 2009 Nov;17(11):2119-20.
PMID: 18421273
citation: Cox TL, Krukowski R, Love SJ, Eddings K, DiCarlo M, Chang JY, Prewitt TE, West DS. Stress management-augmented behavioral weight loss intervention for African American women: a pilot, randomized controlled trial. Health Educ Behav. 2013 Feb;40(1):78-87. doi: 10.1177/1090198112439411. Epub 2012 Apr 13.
PMID: 22505570
citation: Samuel-Hodge CD, Headen SW, Skelly AH, Ingram AF, Keyserling TC, Jackson EJ, Ammerman AS, Elasy TA. Influences on day-to-day self-management of type 2 diabetes among African-American women: spirituality, the multi-caregiver role, and other social context factors. Diabetes Care. 2000 Jul;23(7):928-33. doi: 10.2337/diacare.23.7.928.
PMID: 10895842
citation: Fitzgibbon ML, Tussing-Humphreys LM, Porter JS, Martin IK, Odoms-Young A, Sharp LK. Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature. Obes Rev. 2012 Mar;13(3):193-213. doi: 10.1111/j.1467-789X.2011.00945.x. Epub 2011 Nov 10.
PMID: 22074195
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: Danielle Braxton, MPH, RD
investigator title: Graduate Research Assistant