<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/NCT02968615</url>
  </required_header>
  <id_info>
    <org_study_id>H00007555</org_study_id>
    <nct_id>NCT02968615</nct_id>
  </id_info>
  <brief_title>Simple Changes Weight Loss Intervention</brief_title>
  <official_title>Simple Changes Weight Loss Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators examined feasibility and acceptability of a non-restrictive diet focused on&#xD;
      increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled in a&#xD;
      12-week assessment which included 6 bi-weekly individual dietary counseling sessions to&#xD;
      attain a daily goal of higher fiber (&gt;35 g/day) and lean protein (0.8 g per kilogram/day of&#xD;
      individual's ideal body weight).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were instructed to increase both their dietary fiber intake to 35 g/day and&#xD;
      protein intake to 0.8 g per kilogram/day of their ideal body weight. Loss of 5% of their body&#xD;
      weight are considered to achieve the weight-loss goal. The intervention included 6 bi-weekly,&#xD;
      30-minute individual dietary counseling sessions over 12-weeks. Behavioral strategies&#xD;
      including self-monitoring, problem solving, goal setting, stimulus control, food&#xD;
      substitution, and relapse prevention were taught to assist participants in meeting their&#xD;
      fiber and protein goals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">June 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>12 weeks</time_frame>
    <description>kg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total energy</measure>
    <time_frame>12 weeks</time_frame>
    <description>kcal/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fiber</measure>
    <time_frame>12 weeks</time_frame>
    <description>g/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein</measure>
    <time_frame>12 weeks</time_frame>
    <description>g/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saturated fat</measure>
    <time_frame>12 weeks</time_frame>
    <description>percent of calories</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>fiber &amp; protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dietary change condition that focuses exclusively on increasing fiber and protein.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Intervention</intervention_name>
    <description>Participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. Patients in both conditions will receive intensive dietary instruction for 6 weeks, followed by a 6 weeks maintenance phase. Participants received dietary instructions via individual and group sessions led by registered dietitians.</description>
    <arm_group_label>fiber &amp; protein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. interested in losing weight and have a body mass index (BMI) 30-45 kg/m2;&#xD;
&#xD;
          2. ages 21 to 70;&#xD;
&#xD;
          3. able to provide informed consent;&#xD;
&#xD;
          4. physician's approval of his/her patients to participate;&#xD;
&#xD;
          5. non-smoker (given nicotine's effect on weight suppression, on HDL, and smoking&#xD;
             cessation's effect on weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. clinically diagnosed diabetes, or an HbA1c ≥ 6.5%;&#xD;
&#xD;
          2. an acute coronary event within the previous 6 months;&#xD;
&#xD;
          3. pregnant or lactating;&#xD;
&#xD;
          4. plans to move out of the area within the 12-week study period;&#xD;
&#xD;
          5. diagnosis of a medical condition that precludes adherence to study dietary&#xD;
             recommendations (e.g., inflammatory bowel disease, active diverticulitis, renal&#xD;
             disease);&#xD;
&#xD;
          6. following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet or&#xD;
             participating in a weight loss program;&#xD;
&#xD;
          7. previously had bariatric surgery;&#xD;
&#xD;
          8. currently using weight loss medication;&#xD;
&#xD;
          9. diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa or binge eating);&#xD;
&#xD;
         10. unable to provide consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunsheng Ma, MD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Worcester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Yunsheng Ma</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>fiber</keyword>
  <keyword>lean protein</keyword>
  <keyword>loss weight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Please contact with PI</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/NCT02968615
org study id: H00007555
nct id: NCT02968615
lead sponsor: 
has dmc: Yes
The investigators examined feasibility and acceptability of a non-restrictive diet focused on
      increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled in a
      12-week assessment which included 6 bi-weekly individual dietary counseling sessions to
      attain a daily goal of higher fiber (>35 g/day) and lean protein (0.8 g per kilogram/day of
      individual's ideal body weight).
Participants were instructed to increase both their dietary fiber intake to 35 g/day and
      protein intake to 0.8 g per kilogram/day of their ideal body weight. Loss of 5% of their body
      weight are considered to achieve the weight-loss goal. The intervention included 6 bi-weekly,
      30-minute individual dietary counseling sessions over 12-weeks. Behavioral strategies
      including self-monitoring, problem solving, goal setting, stimulus control, food
      substitution, and relapse prevention were taught to assist participants in meeting their
      fiber and protein goals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight loss
time frame: 12 weeks
description: kg
measure: Total energy
time frame: 12 weeks
description: kcal/day
measure: Fiber
time frame: 12 weeks
description: g/day
measure: Protein
time frame: 12 weeks
description: g/day
measure: Saturated fat
time frame: 12 weeks
description: percent of calories
arm group label: fiber & protein
arm group type: Experimental
description: A single dietary change condition that focuses exclusively on increasing fiber and protein.
intervention type: Behavioral
intervention name: Dietary Intervention
description: Participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. Patients in both conditions will receive intensive dietary instruction for 6 weeks, followed by a 6 weeks maintenance phase. Participants received dietary instructions via individual and group sessions led by registered dietitians.
arm group label: fiber & protein
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yunsheng Ma, MD, Ph.D.
role: Principal Investigator
affiliation: University of Massachusetts, Worcester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Yunsheng Ma
investigator title: Associate professor
mesh term: Overweight
mesh term: Weight Loss
sharing ipd: Undecided
ipd description: Please contact with PI