<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/NCT01664715</url>
  </required_header>
  <id_info>
    <org_study_id>HSCL19775</org_study_id>
    <secondary_id>R01HL111842</secondary_id>
    <nct_id>NCT01664715</nct_id>
  </id_info>
  <brief_title>A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain</brief_title>
  <acronym>POWeR</acronym>
  <official_title>A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels&#xD;
      of recommended exercise in initially overweight and obese sedentary men and women on the&#xD;
      prevention of weight regain. Participants will complete a 3 mo. weight loss intervention of&#xD;
      decreased energy intake (EI) and increased energy expenditure (100 minutes of physical&#xD;
      activity per week). Participants achieving clinically significant weight loss (&gt; 5% of&#xD;
      initial weight), will be randomly assigned to 12 mos. of exercise at levels of energy&#xD;
      expenditure of exercise (EEEx) recommended by Health and Human Services (HHS), American&#xD;
      College of Sports Medicine(ACSM), Institute of Medicine (IOM): 150, 225, or 300 minutes per&#xD;
      week. Major outcome assessments will occur prior to weight loss (-3 mos.), at completion of&#xD;
      weight loss (0 mos.), at the midpoint (6 mos.), and completion of weight maintenance (12&#xD;
      mos.).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a randomized trial in 287 overweight and obese, sedentary adults&#xD;
      (at least 50% women). Participants achieving clinically significant weight loss (≥5%)&#xD;
      following a 3 mo. reduced energy diet and a program of PA (100 min/wk) will be randomly&#xD;
      assigned to either maintain exercise at 150 min/wk. or increase exercise to 225 min/wk or 300&#xD;
      min/wk. while consuming a weight gain prevention diet over a 12 mo. period. Exercise will be&#xD;
      verified (combination of on-site and HR monitor) and EEEx will be measured at 5 mo. intervals&#xD;
      beginning at mo. 5. In-person behaviorally based clinic meetings will be conducted weekly&#xD;
      during the 3 mo. weight loss period (-3 to 0 mos.) and during the first 3 mos. of the weight&#xD;
      regain prevention period. During the final 9 mos. of weight regain prevention, clinics will&#xD;
      be held bi-monthly using group conference calls. We have not proposed to randomize&#xD;
      participants to a true control group (i.e. no exercise or diet) following the 3 mo. weight&#xD;
      loss program as published data indicates significant weight regain in individuals receiving&#xD;
      no follow-up treatment after weight loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevention of Weight Regain</measure>
    <time_frame>12 Months</time_frame>
    <description>To compare the effectiveness of 3 exercise recommendations on the prevention of weight regain over 12 mos. subsequent to clinically significant weight loss (&gt; 5%). We expect participants will regain weight in a dose-response manner, i.e. greatest, intermediate and least weight regain for the 150, 225, and 300 minute. groups, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender Differences in Weight Regain</measure>
    <time_frame>12 Months</time_frame>
    <description>To evaluate gender differences in weight regain over 12 months in response to 3 exercise recommendations. Based on available preliminary data we expect men will regain less weight than women.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compensatory Changes to three exercise levels</measure>
    <time_frame>12 Months</time_frame>
    <description>Evaluating the impact of potential compensatory changes in daily physical activity and energy intake on weight regain in response to 3 exercise recommendations. Any observed compensatory responses would inform the development of subsequent targeted interventions.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">287</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>150 Minutes per Week</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Performs 150 minutes of physical activity per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>225 Minutes per Week</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Performs 225 minutes of physical activity per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>300 Minutes per Week</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Performs 300 minutes of physical activity per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>150 Min/Week</intervention_name>
    <description>Performs 150 min/wk of planned moderate intensity aerobic exercise.</description>
    <arm_group_label>150 Minutes per Week</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>225 Min/Week</intervention_name>
    <description>Performs 225 min/wk of planned moderate intensity aerobic exercise.</description>
    <arm_group_label>225 Minutes per Week</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>300 Min/Week</intervention_name>
    <description>Performs 300 min/wk of planned moderate intensity aerobic exercise.</description>
    <arm_group_label>300 Minutes per Week</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 to 55 years.&#xD;
&#xD;
          -  BMI of 25 to 45.0.&#xD;
&#xD;
          -  Clearance for participation from their Primary Care Physician (PCP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a research project involving weight loss or exercise in the previous&#xD;
             6 mos., as these proximal experiences may impact the results of this study.&#xD;
&#xD;
          -  Participation in a regular exercise program (i.e., &gt; 500 kcal/wk. of planned activity&#xD;
             as estimated by questionnaire)&#xD;
&#xD;
          -  Not weight stable (+ or - 4.5 kg) for 3 mos. prior to intake.&#xD;
&#xD;
          -  Unwilling to be randomized to 1 of 3 exercise groups subsequent to weight loss.&#xD;
&#xD;
          -  Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following&#xD;
             15 mos.&#xD;
&#xD;
          -  Serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e.,&#xD;
             heart attack, angioplasty, etc.). This is determined by the individual's physician via&#xD;
             the clearance to participate in the investigation and the health history (Appendix)&#xD;
             interpreted by the staff physician.&#xD;
&#xD;
          -  Eating disorders as determined by the Eating Attitudes Test using a score of 20 or&#xD;
             greater&#xD;
&#xD;
          -  Current treatment for psychological problems, or taking psychotropic medications&#xD;
&#xD;
          -  Medications known to significantly affect weight (gain or loss).&#xD;
&#xD;
          -  Adherence to specialized diet regimens, i.e., multiple food allergies, vegetarian,&#xD;
             macrobiotic, etc.&#xD;
&#xD;
          -  Do not have access to grocery shopping and meal preparation (i.e. those in military,&#xD;
             college with cafeteria plan, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Donnelly, EdD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas - Robinson Hall</name>
      <address>
        <city>Lawrence</city>
        <state>Kansas</state>
        <zip>66045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas</investigator_affiliation>
    <investigator_full_name>Joseph Donnelly</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Exercise</keyword>
  <keyword>Weight Loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT01664715
org study id: HSCL19775
secondary id: R01HL111842
nct id: NCT01664715
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels
      of recommended exercise in initially overweight and obese sedentary men and women on the
      prevention of weight regain. Participants will complete a 3 mo. weight loss intervention of
      decreased energy intake (EI) and increased energy expenditure (100 minutes of physical
      activity per week). Participants achieving clinically significant weight loss (> 5% of
      initial weight), will be randomly assigned to 12 mos. of exercise at levels of energy
      expenditure of exercise (EEEx) recommended by Health and Human Services (HHS), American
      College of Sports Medicine(ACSM), Institute of Medicine (IOM): 150, 225, or 300 minutes per
      week. Major outcome assessments will occur prior to weight loss (-3 mos.), at completion of
      weight loss (0 mos.), at the midpoint (6 mos.), and completion of weight maintenance (12
      mos.).
The investigators propose a randomized trial in 287 overweight and obese, sedentary adults
      (at least 50% women). Participants achieving clinically significant weight loss (≥5%)
      following a 3 mo. reduced energy diet and a program of PA (100 min/wk) will be randomly
      assigned to either maintain exercise at 150 min/wk. or increase exercise to 225 min/wk or 300
      min/wk. while consuming a weight gain prevention diet over a 12 mo. period. Exercise will be
      verified (combination of on-site and HR monitor) and EEEx will be measured at 5 mo. intervals
      beginning at mo. 5. In-person behaviorally based clinic meetings will be conducted weekly
      during the 3 mo. weight loss period (-3 to 0 mos.) and during the first 3 mos. of the weight
      regain prevention period. During the final 9 mos. of weight regain prevention, clinics will
      be held bi-monthly using group conference calls. We have not proposed to randomize
      participants to a true control group (i.e. no exercise or diet) following the 3 mo. weight
      loss program as published data indicates significant weight regain in individuals receiving
      no follow-up treatment after weight loss.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prevention of Weight Regain
time frame: 12 Months
description: To compare the effectiveness of 3 exercise recommendations on the prevention of weight regain over 12 mos. subsequent to clinically significant weight loss (> 5%). We expect participants will regain weight in a dose-response manner, i.e. greatest, intermediate and least weight regain for the 150, 225, and 300 minute. groups, respectively.
measure: Gender Differences in Weight Regain
time frame: 12 Months
description: To evaluate gender differences in weight regain over 12 months in response to 3 exercise recommendations. Based on available preliminary data we expect men will regain less weight than women.
measure: Compensatory Changes to three exercise levels
time frame: 12 Months
description: Evaluating the impact of potential compensatory changes in daily physical activity and energy intake on weight regain in response to 3 exercise recommendations. Any observed compensatory responses would inform the development of subsequent targeted interventions.
arm group label: 150 Minutes per Week
arm group type: Active Comparator
description: Performs 150 minutes of physical activity per week.
arm group label: 225 Minutes per Week
arm group type: Active Comparator
description: Performs 225 minutes of physical activity per week.
arm group label: 300 Minutes per Week
arm group type: Active Comparator
description: Performs 300 minutes of physical activity per week.
intervention type: Behavioral
intervention name: 150 Min/Week
description: Performs 150 min/wk of planned moderate intensity aerobic exercise.
arm group label: 150 Minutes per Week
intervention type: Behavioral
intervention name: 225 Min/Week
description: Performs 225 min/wk of planned moderate intensity aerobic exercise.
arm group label: 225 Minutes per Week
intervention type: Behavioral
intervention name: 300 Min/Week
description: Performs 300 min/wk of planned moderate intensity aerobic exercise.
arm group label: 300 Minutes per Week
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: No
last name: Joseph Donnelly, EdD
role: Principal Investigator
affiliation: University of Kansas
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas
investigator full name: Joseph Donnelly
investigator title: Professor
mesh term: Overweight
mesh term: Body Weight
mesh term: Weight Loss