<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/NCT02985307</url>
  </required_header>
  <id_info>
    <org_study_id>16/SS/0200</org_study_id>
    <nct_id>NCT02985307</nct_id>
  </id_info>
  <brief_title>Impact of Mobile Phone Texting Service to Support Weight Loss</brief_title>
  <acronym>SMS</acronym>
  <official_title>Efficacy of Mobile Telehealth Short Message Service (SMS) as a Facilitator for Weight Management: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queen Margaret University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Lothian</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 the efficacy of a mobile telehealth short message service as a&#xD;
      facilitator for weight management. Half of the participants will receive a standard care&#xD;
      weight management group intervention, while the other half will receive daily text messages&#xD;
      via their mobile phone to help facilitate weight loss. It is hypothesized that the&#xD;
      intervention group receiving text messages will be as successful as the control group at&#xD;
      achieving weight loss over a 3-month period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity, a chronic progressive disease, has become a major public health concern due to its&#xD;
      increasing prevalence and association with many adverse health conditions including type 2&#xD;
      diabetes, many cancers and heart disease. The number of individuals requiring weight&#xD;
      management intervention is increasing necessitating the need to explore other initiatives.&#xD;
&#xD;
      Developments in health technology are growing in popularity and there is increasing evidence&#xD;
      that this type of intervention for obesity can significantly improve clinical outcomes.&#xD;
      Mobile phones are a popular means of communication that provide a convenient, inexpensive&#xD;
      means to deliver a health technology intervention.Short message service (SMS) by mobile phone&#xD;
      has the potential to serve as an intervention medium to promote weight loss that is&#xD;
      accessible and easy to use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">April 28, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>3 months</time_frame>
    <description>weight recorded in Kg on a Seca 635 medical digital load cell balance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioural changes necessary for weight loss</measure>
    <time_frame>3 months</time_frame>
    <description>Self reported dietary and physical activity changes using 7-day food and exercise diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat changes</measure>
    <time_frame>3 months</time_frame>
    <description>Measured using a medically approved and validated scale: Tanita SC-240MA body composition analyser</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass index</measure>
    <time_frame>3 months</time_frame>
    <description>calculated using the formula weight in kg divided by height squared in metres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>3months</time_frame>
    <description>Height measured using Seca portable stadiometer with a sliding head plate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Short Message Text Service</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive short messages daily via their mobile phone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Weight Management Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants attend standard group weight management sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Short Message Text Service</intervention_name>
    <description>A service designed by professionals inside the National Health Service (NHS) to provide support and advice for participants to manage weight loss. It combines the expertise of the healthcare team and the convenience of the participant's own mobile phone to give prompts and advice to act on. It makes use of the familiar and convenient mobile phone text service 'SMS' to communicate directly with participants.</description>
    <arm_group_label>Short Message Text Service</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Weight Management Group</intervention_name>
    <description>A standard Lothian NHS group programme facilitated by a Dietitian</description>
    <arm_group_label>Standard Weight Management Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index &gt; 35kg/m requiring to lose weight for an operation or having a&#xD;
             co-morbidity including diabetes, osteoarthritis, high cholesterol, asthma, heart&#xD;
             disease, high blood pressure or sleep apnoea or with a body mass &gt;40kg/m with no&#xD;
             co-morbidities.&#xD;
&#xD;
          -  Own a mobile phone&#xD;
&#xD;
          -  Have the ability to use short message service&#xD;
&#xD;
          -  Have access to weighing scales&#xD;
&#xD;
          -  Mentally capable of informed consent&#xD;
&#xD;
          -  Have the ability to read and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled Hypothyroidism&#xD;
&#xD;
          -  Poorly controlled psychiatric illness&#xD;
&#xD;
          -  Current alcohol or drug abuse&#xD;
&#xD;
          -  Learning disability&#xD;
&#xD;
          -  Do not own a mobile phone&#xD;
&#xD;
          -  Do not have access to weighing scales&#xD;
&#xD;
          -  Does not have the ability to read or speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas McBean, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Queen Margaret University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elizabeth McAnally</name>
      <address>
        <city>Edinburgh</city>
        <state>West Lothian</state>
        <zip>EH49 6SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Lothian</name>
      <address>
        <city>Edinburgh</city>
        <state>West Lothian</state>
        <zip>EH54 6PP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.comminit.com/global/content/mhealth-new-horizons-health-through-mobile-technologies</url>
    <description>World Health Organisation</description>
  </link>
  <results_reference>
    <citation>Patrick K, Raab F, Adams MA, Dillon L, Zabinski M, Rock CL, Griswold WG, Norman GJ. A text message-based intervention for weight loss: randomized controlled trial. J Med Internet Res. 2009 Jan 13;11(1):e1. doi: 10.2196/jmir.1100.</citation>
    <PMID>19141433</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified participant data for all primary and secondary outcome measures will be made available within 6months of study completion</ipd_description>
  </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/NCT02985307
org study id: 16/SS/0200
nct id: NCT02985307
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the efficacy of a mobile telehealth short message service as a
      facilitator for weight management. Half of the participants will receive a standard care
      weight management group intervention, while the other half will receive daily text messages
      via their mobile phone to help facilitate weight loss. It is hypothesized that the
      intervention group receiving text messages will be as successful as the control group at
      achieving weight loss over a 3-month period.
Obesity, a chronic progressive disease, has become a major public health concern due to its
      increasing prevalence and association with many adverse health conditions including type 2
      diabetes, many cancers and heart disease. The number of individuals requiring weight
      management intervention is increasing necessitating the need to explore other initiatives.

      Developments in health technology are growing in popularity and there is increasing evidence
      that this type of intervention for obesity can significantly improve clinical outcomes.
      Mobile phones are a popular means of communication that provide a convenient, inexpensive
      means to deliver a health technology intervention.Short message service (SMS) by mobile phone
      has the potential to serve as an intervention medium to promote weight loss that is
      accessible and easy to use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Weight Loss
time frame: 3 months
description: weight recorded in Kg on a Seca 635 medical digital load cell balance
measure: Behavioural changes necessary for weight loss
time frame: 3 months
description: Self reported dietary and physical activity changes using 7-day food and exercise diaries
measure: Body fat changes
time frame: 3 months
description: Measured using a medically approved and validated scale: Tanita SC-240MA body composition analyser
measure: Body Mass index
time frame: 3 months
description: calculated using the formula weight in kg divided by height squared in metres
measure: Height
time frame: 3months
description: Height measured using Seca portable stadiometer with a sliding head plate
arm group label: Short Message Text Service
arm group type: Experimental
description: Participants receive short messages daily via their mobile phone
arm group label: Standard Weight Management Group
arm group type: Active Comparator
description: Participants attend standard group weight management sessions
intervention type: Behavioral
intervention name: Short Message Text Service
description: A service designed by professionals inside the National Health Service (NHS) to provide support and advice for participants to manage weight loss. It combines the expertise of the healthcare team and the convenience of the participant's own mobile phone to give prompts and advice to act on. It makes use of the familiar and convenient mobile phone text service 'SMS' to communicate directly with participants.
arm group label: Short Message Text Service
intervention type: Behavioral
intervention name: Standard Weight Management Group
description: A standard Lothian NHS group programme facilitated by a Dietitian
arm group label: Standard Weight Management Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas McBean, PhD
role: Study Director
affiliation: Queen Margaret University
facility: 
facility: 
country: United Kingdom
url: http://www.comminit.com/global/content/mhealth-new-horizons-health-through-mobile-technologies
description: World Health Organisation
citation: Patrick K, Raab F, Adams MA, Dillon L, Zabinski M, Rock CL, Griswold WG, Norman GJ. A text message-based intervention for weight loss: randomized controlled trial. J Med Internet Res. 2009 Jan 13;11(1):e1. doi: 10.2196/jmir.1100.
PMID: 19141433
responsible party type: Sponsor
sharing ipd: Yes
ipd description: De-identified participant data for all primary and secondary outcome measures will be made available within 6months of study completion