<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/NCT03254940</url>
  </required_header>
  <id_info>
    <org_study_id>D0752</org_study_id>
    <nct_id>NCT03254940</nct_id>
  </id_info>
  <brief_title>Charge: A Text Messaging-based Weight Loss Intervention</brief_title>
  <official_title>Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study evaluates different versions of a text messaging-based app for weight loss. This&#xD;
      study will place participants to 1 of 32 experimental conditions that reflect different&#xD;
      texting components and levels. Participants will be randomized to a condition. The&#xD;
      investigators will recruit 448 adults into a 6-month weight loss program, with an additional&#xD;
      follow-up 6-months after the intervention ends.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standalone text messaging-based weight loss treatments are scalable and can achieve&#xD;
      population reach. However, these interventions are also modular; they can be delivered&#xD;
      independently to maximize cost-effectiveness or combined with other approaches (e.g. provider&#xD;
      counseling) to maximize outcomes. This study is a 12-month experimental trial among 448&#xD;
      adults with obesity. All participants will receive a core 6-month weight loss texting&#xD;
      intervention that includes tailored behavior change goals, interactive self-monitoring,&#xD;
      automated feedback, and skills training. Participants will be randomly assigned to 1 of 32&#xD;
      different experimental conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Actual">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">June 29, 2019</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>Factorial Assignment</intervention_model>
    <intervention_model_description>The investigators will use a full factorial design to randomize participants to experimental conditions that reflect the texting intervention components: motivational messaging (self- vs expert-generated), texting frequency (daily vs weekly), reminders (one reminder v. multiple reminders), feedback type (summary score v. specific feedback) and comparison unit (to self v. to a group of people). The full factorial design is power efficient, logistically feasible (because we manipulate conditions using technology) and will allow the investigators to examine the most important main and interaction effects among components.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>baseline &amp; 6 months</time_frame>
    <description>absolute change in weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in diet</measure>
    <time_frame>baseline, 6 &amp; 12 months</time_frame>
    <description>To experimentally determine the effects of text messaging components and levels on change in diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>baseline, 6 &amp; 12 months</time_frame>
    <description>To experimentally determine the effects of text messaging components and levels on change in physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in categorical weight loss (&gt; 5%) at 6-months</measure>
    <time_frame>baseline, 6 &amp; 12 months</time_frame>
    <description>To experimentally determine the effects of text messaging components and levels on change in categorical weight loss (&gt;5%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight loss maintenance</measure>
    <time_frame>baseline, 6 &amp; 12 months</time_frame>
    <description>To experimentally determine the effects of text messaging components and levels on change in 12-month maintenance of weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure engagement in the intervention</measure>
    <time_frame>baseline, 6 &amp; 12 months</time_frame>
    <description>To determine how many responses we receive to our questions and to measure associations of engagement with weight change at 6- and 12- months. We will also model trajectories of change in engagement over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Cost-effectiveness of interventions</measure>
    <time_frame>baseline &amp; 6 months</time_frame>
    <description>To calculate the cost of the intervention's implementation and compare cost effectiveness of each intervention.</description>
  </secondary_outcome>
  <number_of_arms>32</number_of_arms>
  <enrollment type="Actual">534</enrollment>
  <condition>Weight Loss</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Arm 1: WT-SM-OR-SS-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: WT-SM-OR-SS-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3: WT-SM-OR-SF-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4: WT-SM-OR-SF-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 5: WT-SM-MR-SS-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 6: WT-SM-MR-SS-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 7: WT-SM-MR-SF-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 8: WT-SM-MR-SF-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 9: WT-EM-OR-SS-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 10: WT-EM-OR-SS-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 11: WT-EM-OR-SF-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 12: WT-EM-OR-SF-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 13: WT-EM-MR-SS-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 14: WT-EM-MR-SS-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 15: WT-EM-MR-SF-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 16: WT-EM-MR-SF-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 17: DT-SM-OR-SS-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 18: DT-SM-OR-SS-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 19: DT-SM-OR-SF-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 20: DT-SM-OR-SF-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 21: DT-SM-MR-SS-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 22: DT-SM-MR-SS-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 23: DT-SM-MR-SF-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 24: DT-SM-MR-SF-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 25: DT-EM-OR-SS-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 26: DT-EM-OR-SS-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 27: DT-EM-OR-SF-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 28: DT-EM-OR-SF-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 29: DT-EM-MR-SS-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 30: DT-EM-MR-SS-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 31: DT-EM-MR-GF-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 32: DT-EM-MR-GF-CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Charge</intervention_name>
    <description>Text messaging-based study to determine effect of different components on weight loss.</description>
    <arm_group_label>Arm 10: WT-EM-OR-SS-CG</arm_group_label>
    <arm_group_label>Arm 11: WT-EM-OR-SF-CS</arm_group_label>
    <arm_group_label>Arm 12: WT-EM-OR-SF-CG</arm_group_label>
    <arm_group_label>Arm 13: WT-EM-MR-SS-CS</arm_group_label>
    <arm_group_label>Arm 14: WT-EM-MR-SS-CG</arm_group_label>
    <arm_group_label>Arm 15: WT-EM-MR-SF-CS</arm_group_label>
    <arm_group_label>Arm 16: WT-EM-MR-SF-CG</arm_group_label>
    <arm_group_label>Arm 17: DT-SM-OR-SS-CS</arm_group_label>
    <arm_group_label>Arm 18: DT-SM-OR-SS-CG</arm_group_label>
    <arm_group_label>Arm 19: DT-SM-OR-SF-CS</arm_group_label>
    <arm_group_label>Arm 1: WT-SM-OR-SS-CS</arm_group_label>
    <arm_group_label>Arm 20: DT-SM-OR-SF-CG</arm_group_label>
    <arm_group_label>Arm 21: DT-SM-MR-SS-CS</arm_group_label>
    <arm_group_label>Arm 22: DT-SM-MR-SS-CG</arm_group_label>
    <arm_group_label>Arm 23: DT-SM-MR-SF-CS</arm_group_label>
    <arm_group_label>Arm 24: DT-SM-MR-SF-CG</arm_group_label>
    <arm_group_label>Arm 25: DT-EM-OR-SS-CS</arm_group_label>
    <arm_group_label>Arm 26: DT-EM-OR-SS-CG</arm_group_label>
    <arm_group_label>Arm 27: DT-EM-OR-SF-CS</arm_group_label>
    <arm_group_label>Arm 28: DT-EM-OR-SF-CG</arm_group_label>
    <arm_group_label>Arm 29: DT-EM-MR-SS-CS</arm_group_label>
    <arm_group_label>Arm 2: WT-SM-OR-SS-CG</arm_group_label>
    <arm_group_label>Arm 30: DT-EM-MR-SS-CG</arm_group_label>
    <arm_group_label>Arm 31: DT-EM-MR-GF-CS</arm_group_label>
    <arm_group_label>Arm 32: DT-EM-MR-GF-CG</arm_group_label>
    <arm_group_label>Arm 3: WT-SM-OR-SF-CS</arm_group_label>
    <arm_group_label>Arm 4: WT-SM-OR-SF-CG</arm_group_label>
    <arm_group_label>Arm 5: WT-SM-MR-SS-CS</arm_group_label>
    <arm_group_label>Arm 6: WT-SM-MR-SS-CG</arm_group_label>
    <arm_group_label>Arm 7: WT-SM-MR-SF-CS</arm_group_label>
    <arm_group_label>Arm 8: WT-SM-MR-SF-CG</arm_group_label>
    <arm_group_label>Arm 9: WT-EM-OR-SS-CS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  males and females aged 18-65 years&#xD;
&#xD;
          -  participants have English language proficiency&#xD;
&#xD;
          -  participants have a BMI between 25-40 kg/m2&#xD;
&#xD;
          -  Participants will own a smartphone&#xD;
&#xD;
          -  Participants will be willing to receive multiple text messages daily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior or planned bariatric surgery&#xD;
&#xD;
          -  psychiatric hospitalization in past 12 months&#xD;
&#xD;
          -  pregnancy, nursing, or planned pregnancy&#xD;
&#xD;
          -  history of a cardiovascular event&#xD;
&#xD;
          -  history of an eating disorder&#xD;
&#xD;
          -  history of a condition (e.g., end stage renal disease, cancer, schizophrenia) or use&#xD;
             of medications (e.g., lithium, steroids, anti-psychotics) that would affect weight&#xD;
             measurement, for which weight loss is contraindicated, or might promote weight change&#xD;
&#xD;
          -  current participation in a weight loss trial and/or recent weight loss &gt; 10%&#xD;
&#xD;
          -  investigator discretion for safety reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary G Bennett, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bishop-MacDermott Family Professor of Psychology, Global Health &amp; Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Collins LM, Baker TB, Mermelstein RJ, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011 Apr;41(2):208-26. doi: 10.1007/s12160-010-9253-x.</citation>
    <PMID>21132416</PMID>
  </reference>
  <reference>
    <citation>Ogden CL, Carroll MD, Flegal KM. Prevalence of obesity in the United States. JAMA. 2014 Jul;312(2):189-90. doi: 10.1001/jama.2014.6228. No abstract available.</citation>
    <PMID>25005661</PMID>
  </reference>
  <reference>
    <citation>Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.</citation>
    <PMID>22253363</PMID>
  </reference>
  <reference>
    <citation>Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. No abstract available.</citation>
    <PMID>26098405</PMID>
  </reference>
  <reference>
    <citation>Ogden CL, Lamb MM, Carroll MD, Flegal KM. Obesity and socioeconomic status in adults: United States, 2005-2008. NCHS Data Brief. 2010 Dec;(50):1-8.</citation>
    <PMID>21211165</PMID>
  </reference>
  <reference>
    <citation>Rodriguez F, Ferdinand KC. Hypertension in minority populations: new guidelines and emerging concepts. Adv Chronic Kidney Dis. 2015 Mar;22(2):145-53. doi: 10.1053/j.ackd.2014.08.004.</citation>
    <PMID>25704352</PMID>
  </reference>
  <reference>
    <citation>Befort CA, Nazir N, Perri MG. Prevalence of obesity among adults from rural and urban areas of the United States: findings from NHANES (2005-2008). J Rural Health. 2012 Fall;28(4):392-7. doi: 10.1111/j.1748-0361.2012.00411.x. Epub 2012 May 31.</citation>
    <PMID>23083085</PMID>
  </reference>
  <reference>
    <citation>Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3029-3030.</citation>
    <PMID>24239920</PMID>
  </reference>
  <reference>
    <citation>Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, Marks JS. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003 Jan 1;289(1):76-9. doi: 10.1001/jama.289.1.76.</citation>
    <PMID>12503980</PMID>
  </reference>
  <reference>
    <citation>Finkelstein EA, Brown DS, Wrage LA, Allaire BT, Hoerger TJ. Individual and aggregate years-of-life-lost associated with overweight and obesity. Obesity (Silver Spring). 2010 Feb;18(2):333-9. doi: 10.1038/oby.2009.253. Epub 2009 Aug 13.</citation>
    <PMID>19680230</PMID>
  </reference>
  <reference>
    <citation>Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.</citation>
    <PMID>12517229</PMID>
  </reference>
  <reference>
    <citation>Han X, Stevens J, Truesdale KP, Bradshaw PT, Kucharska-Newton A, Prizment AE, Platz EA, Joshu CE. Body mass index at early adulthood, subsequent weight change and cancer incidence and mortality. Int J Cancer. 2014 Dec 15;135(12):2900-9. doi: 10.1002/ijc.28930. Epub 2014 May 8.</citation>
    <PMID>24771654</PMID>
  </reference>
  <reference>
    <citation>Osei-Assibey G, Kyrou I, Adi Y, Kumar S, Matyka K. Dietary and lifestyle interventions for weight management in adults from minority ethnic/non-White groups: a systematic review. Obes Rev. 2010 Nov;11(11):769-76. doi: 10.1111/j.1467-789X.2009.00695.x.</citation>
    <PMID>20059708</PMID>
  </reference>
  <reference>
    <citation>Bennett GG, Glasgow RE. The delivery of public health interventions via the Internet: actualizing their potential. Annu Rev Public Health. 2009;30:273-92. doi: 10.1146/annurev.publhealth.031308.100235.</citation>
    <PMID>19296777</PMID>
  </reference>
  <reference>
    <citation>Evans W, Nielsen PE, Szekely DR, Bihm JW, Murray EA, Snider J, Abroms LC. Dose-response effects of the text4baby mobile health program: randomized controlled trial. JMIR Mhealth Uhealth. 2015 Jan 28;3(1):e12. doi: 10.2196/mhealth.3909.</citation>
    <PMID>25630361</PMID>
  </reference>
  <reference>
    <citation>Jordan ET, Ray EM, Johnson P, Evans WD. Text4Baby: using text messaging to improve maternal and newborn health. Nurs Womens Health. 2011 Jun-Jul;15(3):206-12. doi: 10.1111/j.1751-486X.2011.01635.x. No abstract available.</citation>
    <PMID>21672170</PMID>
  </reference>
  <reference>
    <citation>Shapiro JR, Koro T, Doran N, Thompson S, Sallis JF, Calfas K, Patrick K. Text4Diet: a randomized controlled study using text messaging for weight loss behaviors. Prev Med. 2012 Nov;55(5):412-7. doi: 10.1016/j.ypmed.2012.08.011. Epub 2012 Aug 27.</citation>
    <PMID>22944150</PMID>
  </reference>
  <reference>
    <citation>Steinberg DM, Levine EL, Askew S, Foley P, Bennett GG. Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. J Med Internet Res. 2013 Nov 18;15(11):e244. doi: 10.2196/jmir.2844.</citation>
    <PMID>24246427</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>text message</keyword>
  <keyword>digital health</keyword>
  <keyword>weight loss</keyword>
  <keyword>personalized</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03254940
org study id: D0752
nct id: NCT03254940
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates different versions of a text messaging-based app for weight loss. This
      study will place participants to 1 of 32 experimental conditions that reflect different
      texting components and levels. Participants will be randomized to a condition. The
      investigators will recruit 448 adults into a 6-month weight loss program, with an additional
      follow-up 6-months after the intervention ends.
Standalone text messaging-based weight loss treatments are scalable and can achieve
      population reach. However, these interventions are also modular; they can be delivered
      independently to maximize cost-effectiveness or combined with other approaches (e.g. provider
      counseling) to maximize outcomes. This study is a 12-month experimental trial among 448
      adults with obesity. All participants will receive a core 6-month weight loss texting
      intervention that includes tailored behavior change goals, interactive self-monitoring,
      automated feedback, and skills training. Participants will be randomly assigned to 1 of 32
      different experimental conditions.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: The investigators will use a full factorial design to randomize participants to experimental conditions that reflect the texting intervention components: motivational messaging (self- vs expert-generated), texting frequency (daily vs weekly), reminders (one reminder v. multiple reminders), feedback type (summary score v. specific feedback) and comparison unit (to self v. to a group of people). The full factorial design is power efficient, logistically feasible (because we manipulate conditions using technology) and will allow the investigators to examine the most important main and interaction effects among components.
primary purpose: Treatment
masking: Single (Investigator)
measure: Weight
time frame: baseline & 6 months
description: absolute change in weight
measure: Change in diet
time frame: baseline, 6 & 12 months
description: To experimentally determine the effects of text messaging components and levels on change in diet
measure: Change in physical activity
time frame: baseline, 6 & 12 months
description: To experimentally determine the effects of text messaging components and levels on change in physical activity
measure: Change in categorical weight loss (> 5%) at 6-months
time frame: baseline, 6 & 12 months
description: To experimentally determine the effects of text messaging components and levels on change in categorical weight loss (>5%)
measure: weight loss maintenance
time frame: baseline, 6 & 12 months
description: To experimentally determine the effects of text messaging components and levels on change in 12-month maintenance of weight loss
measure: Measure engagement in the intervention
time frame: baseline, 6 & 12 months
description: To determine how many responses we receive to our questions and to measure associations of engagement with weight change at 6- and 12- months. We will also model trajectories of change in engagement over time
measure: Compare Cost-effectiveness of interventions
time frame: baseline & 6 months
description: To calculate the cost of the intervention's implementation and compare cost effectiveness of each intervention.
arm group label: Arm 1: WT-SM-OR-SS-CS
arm group type: Experimental
description: Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self
arm group label: Arm 2: WT-SM-OR-SS-CG
arm group type: Experimental
description: Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group
arm group label: Arm 3: WT-SM-OR-SF-CS
arm group type: Experimental
description: Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self
arm group label: Arm 4: WT-SM-OR-SF-CG
arm group type: Experimental
description: Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
arm group label: Arm 5: WT-SM-MR-SS-CS
arm group type: Experimental
description: Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self.
arm group label: Arm 6: WT-SM-MR-SS-CG
arm group type: Experimental
description: Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
arm group label: Arm 7: WT-SM-MR-SF-CS
arm group type: Experimental
description: Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self
arm group label: Arm 8: WT-SM-MR-SF-CG
arm group type: Experimental
description: Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group
arm group label: Arm 9: WT-EM-OR-SS-CS
arm group type: Experimental
description: Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self
arm group label: Arm 10: WT-EM-OR-SS-CG
arm group type: Experimental
description: Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group
arm group label: Arm 11: WT-EM-OR-SF-CS
arm group type: Experimental
description: Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
arm group label: Arm 12: WT-EM-OR-SF-CG
arm group type: Experimental
description: Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group.
arm group label: Arm 13: WT-EM-MR-SS-CS
arm group type: Experimental
description: Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
arm group label: Arm 14: WT-EM-MR-SS-CG
arm group type: Experimental
description: Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group
arm group label: Arm 15: WT-EM-MR-SF-CS
arm group type: Experimental
description: Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
arm group label: Arm 16: WT-EM-MR-SF-CG
arm group type: Experimental
description: Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group
arm group label: Arm 17: DT-SM-OR-SS-CS
arm group type: Experimental
description: Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self.
arm group label: Arm 18: DT-SM-OR-SS-CG
arm group type: Experimental
description: Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group
arm group label: Arm 19: DT-SM-OR-SF-CS
arm group type: Experimental
description: Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self.
arm group label: Arm 20: DT-SM-OR-SF-CG
arm group type: Experimental
description: Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
arm group label: Arm 21: DT-SM-MR-SS-CS
arm group type: Experimental
description: Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self
arm group label: Arm 22: DT-SM-MR-SS-CG
arm group type: Experimental
description: Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
arm group label: Arm 23: DT-SM-MR-SF-CS
arm group type: Experimental
description: Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self.
arm group label: Arm 24: DT-SM-MR-SF-CG
arm group type: Experimental
description: Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group
arm group label: Arm 25: DT-EM-OR-SS-CS
arm group type: Experimental
description: Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self
arm group label: Arm 26: DT-EM-OR-SS-CG
arm group type: Experimental
description: Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group
arm group label: Arm 27: DT-EM-OR-SF-CS
arm group type: Experimental
description: Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
arm group label: Arm 28: DT-EM-OR-SF-CG
arm group type: Experimental
description: Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group
arm group label: Arm 29: DT-EM-MR-SS-CS
arm group type: Experimental
description: Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
arm group label: Arm 30: DT-EM-MR-SS-CG
arm group type: Experimental
description: Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group
arm group label: Arm 31: DT-EM-MR-GF-CS
arm group type: Experimental
description: Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
arm group label: Arm 32: DT-EM-MR-GF-CG
arm group type: Experimental
description: Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group.
intervention type: Behavioral
intervention name: Charge
description: Text messaging-based study to determine effect of different components on weight loss.
arm group label: Arm 10: WT-EM-OR-SS-CG
arm group label: Arm 11: WT-EM-OR-SF-CS
arm group label: Arm 12: WT-EM-OR-SF-CG
arm group label: Arm 13: WT-EM-MR-SS-CS
arm group label: Arm 14: WT-EM-MR-SS-CG
arm group label: Arm 15: WT-EM-MR-SF-CS
arm group label: Arm 16: WT-EM-MR-SF-CG
arm group label: Arm 17: DT-SM-OR-SS-CS
arm group label: Arm 18: DT-SM-OR-SS-CG
arm group label: Arm 19: DT-SM-OR-SF-CS
arm group label: Arm 1: WT-SM-OR-SS-CS
arm group label: Arm 20: DT-SM-OR-SF-CG
arm group label: Arm 21: DT-SM-MR-SS-CS
arm group label: Arm 22: DT-SM-MR-SS-CG
arm group label: Arm 23: DT-SM-MR-SF-CS
arm group label: Arm 24: DT-SM-MR-SF-CG
arm group label: Arm 25: DT-EM-OR-SS-CS
arm group label: Arm 26: DT-EM-OR-SS-CG
arm group label: Arm 27: DT-EM-OR-SF-CS
arm group label: Arm 28: DT-EM-OR-SF-CG
arm group label: Arm 29: DT-EM-MR-SS-CS
arm group label: Arm 2: WT-SM-OR-SS-CG
arm group label: Arm 30: DT-EM-MR-SS-CG
arm group label: Arm 31: DT-EM-MR-GF-CS
arm group label: Arm 32: DT-EM-MR-GF-CG
arm group label: Arm 3: WT-SM-OR-SF-CS
arm group label: Arm 4: WT-SM-OR-SF-CG
arm group label: Arm 5: WT-SM-MR-SS-CS
arm group label: Arm 6: WT-SM-MR-SS-CG
arm group label: Arm 7: WT-SM-MR-SF-CS
arm group label: Arm 8: WT-SM-MR-SF-CG
arm group label: Arm 9: WT-EM-OR-SS-CS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gary G Bennett, PhD
role: Principal Investigator
affiliation: Bishop-MacDermott Family Professor of Psychology, Global Health & Medicine
facility: 
country: United States
citation: Collins LM, Baker TB, Mermelstein RJ, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011 Apr;41(2):208-26. doi: 10.1007/s12160-010-9253-x.
PMID: 21132416
citation: Ogden CL, Carroll MD, Flegal KM. Prevalence of obesity in the United States. JAMA. 2014 Jul;312(2):189-90. doi: 10.1001/jama.2014.6228. No abstract available.
PMID: 25005661
citation: Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.
PMID: 22253363
citation: Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. No abstract available.
PMID: 26098405
citation: Ogden CL, Lamb MM, Carroll MD, Flegal KM. Obesity and socioeconomic status in adults: United States, 2005-2008. NCHS Data Brief. 2010 Dec;(50):1-8.
PMID: 21211165
citation: Rodriguez F, Ferdinand KC. Hypertension in minority populations: new guidelines and emerging concepts. Adv Chronic Kidney Dis. 2015 Mar;22(2):145-53. doi: 10.1053/j.ackd.2014.08.004.
PMID: 25704352
citation: Befort CA, Nazir N, Perri MG. Prevalence of obesity among adults from rural and urban areas of the United States: findings from NHANES (2005-2008). J Rural Health. 2012 Fall;28(4):392-7. doi: 10.1111/j.1748-0361.2012.00411.x. Epub 2012 May 31.
PMID: 23083085
citation: Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3029-3030.
PMID: 24239920
citation: Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, Marks JS. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003 Jan 1;289(1):76-9. doi: 10.1001/jama.289.1.76.
PMID: 12503980
citation: Finkelstein EA, Brown DS, Wrage LA, Allaire BT, Hoerger TJ. Individual and aggregate years-of-life-lost associated with overweight and obesity. Obesity (Silver Spring). 2010 Feb;18(2):333-9. doi: 10.1038/oby.2009.253. Epub 2009 Aug 13.
PMID: 19680230
citation: Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.
PMID: 12517229
citation: Han X, Stevens J, Truesdale KP, Bradshaw PT, Kucharska-Newton A, Prizment AE, Platz EA, Joshu CE. Body mass index at early adulthood, subsequent weight change and cancer incidence and mortality. Int J Cancer. 2014 Dec 15;135(12):2900-9. doi: 10.1002/ijc.28930. Epub 2014 May 8.
PMID: 24771654
citation: Osei-Assibey G, Kyrou I, Adi Y, Kumar S, Matyka K. Dietary and lifestyle interventions for weight management in adults from minority ethnic/non-White groups: a systematic review. Obes Rev. 2010 Nov;11(11):769-76. doi: 10.1111/j.1467-789X.2009.00695.x.
PMID: 20059708
citation: Bennett GG, Glasgow RE. The delivery of public health interventions via the Internet: actualizing their potential. Annu Rev Public Health. 2009;30:273-92. doi: 10.1146/annurev.publhealth.031308.100235.
PMID: 19296777
citation: Evans W, Nielsen PE, Szekely DR, Bihm JW, Murray EA, Snider J, Abroms LC. Dose-response effects of the text4baby mobile health program: randomized controlled trial. JMIR Mhealth Uhealth. 2015 Jan 28;3(1):e12. doi: 10.2196/mhealth.3909.
PMID: 25630361
citation: Jordan ET, Ray EM, Johnson P, Evans WD. Text4Baby: using text messaging to improve maternal and newborn health. Nurs Womens Health. 2011 Jun-Jul;15(3):206-12. doi: 10.1111/j.1751-486X.2011.01635.x. No abstract available.
PMID: 21672170
citation: Shapiro JR, Koro T, Doran N, Thompson S, Sallis JF, Calfas K, Patrick K. Text4Diet: a randomized controlled study using text messaging for weight loss behaviors. Prev Med. 2012 Nov;55(5):412-7. doi: 10.1016/j.ypmed.2012.08.011. Epub 2012 Aug 27.
PMID: 22944150
citation: Steinberg DM, Levine EL, Askew S, Foley P, Bennett GG. Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. J Med Internet Res. 2013 Nov 18;15(11):e244. doi: 10.2196/jmir.2844.
PMID: 24246427
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No