<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/NCT02230111</url>
  </required_header>
  <id_info>
    <org_study_id>2013-170</org_study_id>
    <nct_id>NCT02230111</nct_id>
  </id_info>
  <brief_title>Impact of Cognitive Dietary Restraint on Perceived Stress, Appetite Sensations, Food Cravings During Energy Restriction</brief_title>
  <official_title>Impact of Cognitive Dietary Restraint on Perceived Stress, Appetite Sensations and Food Cravings During Energy Restriction in Women With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danone Institute International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure the effects of a reduced-calorie low energy density&#xD;
      diet with and without increased cognitive dietary restraint (CDR) on stress (biological&#xD;
      markers and perceived stress), eating behaviours, appetite sensations, anthropometric&#xD;
      variables and women's attitude toward their children's eating behaviours in premenopausal&#xD;
      overweight/obese women in both the short term (immediately after the end of the 4-week&#xD;
      intervention) and longer term (3 months after the end of the intervention). The investigators&#xD;
      hypothesize that cortisol concentrations are higher, appetite sensations are increased (i.e.&#xD;
      increased global appetite score) and food cravings are more prevalent in women of the&#xD;
      energy-restriction-plus-CDR group than in women of the energy-restriction-without-CDR group&#xD;
      after the 4-week intervention. They also hypothesize that perceived stress is higher and food&#xD;
      cravings are more prevalent in women of the energy-restriction-plus-CDR group than in women&#xD;
      of the energy-restriction-without-CDR group at 3-month post intervention. They hypothesize&#xD;
      that no significant difference in body weight changes is observed between the two groups and&#xD;
      that maternal restriction of their child's eating is higher in the&#xD;
      energy-restriction-plus-CDR group than in the energy-restriction-without-CDR group both after&#xD;
      the 4-week intervention and at the 3-month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is clear that a large proportion of individuals regain weight following dietary weight&#xD;
      loss interventions most likely because of homeostatic and non-homeostatic factors favouring a&#xD;
      return to initial energy status. However, studies performed to date have documented these&#xD;
      effects in the context of interventions favouring both energy restriction and CDR. Thus, the&#xD;
      difference between a state of energy restriction alone and a state of energy restriction&#xD;
      combined to CDR on factors regulating energy balance is not known. In order to study this&#xD;
      important question appropriately, we need to create a condition of energy restriction without&#xD;
      increasing CDR, which can only be achieved with a satiating diet (i.e. well-balanced low&#xD;
      energy density diet). This is easier to create in the context of a controlled intervention in&#xD;
      which all foods and drinks are provided. We propose to create, in a controlled context, an&#xD;
      energy restriction for which subjects will be blinded i.e. they will consume less energy than&#xD;
      their energy needs without knowing that they are restrained. Such a design will permit to&#xD;
      document for the first time the independent effects of CDR in the context of a reduced&#xD;
      calorie diet on factors associated with the regulation of energy balance. The proposed study&#xD;
      will also allow exploring the impact of increasing CDR on women's attitude toward their&#xD;
      children's eating behaviours. Taken all together, results arising from the proposed study&#xD;
      will better position the relevance of developing weight loss approaches not focusing on CDR&#xD;
      to favour healthy weight management for women and their family. Data will be collected before&#xD;
      and after the 4-week intervention, as well as 3 months after the end of the intervention. In&#xD;
      order to appropriately test our hypotheses, we cannot state the real purpose of the study in&#xD;
      the informed consent form and women will be told that it is a study about the impact of diet&#xD;
      on blood pressure. However, at the end of the study, women will be debriefed and will sign a&#xD;
      second informed consent form in which the true purpose of the study will be explained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Appetite sensations</measure>
    <time_frame>At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)</time_frame>
    <description>Measurements of appetite sensations will be performed following a standardized meal. After a 12-hour overnight fast, each woman will be invited to eat a standardized breakfast (600 kcal) and to rate her appetite sensations according to 4 visual analog scales (ranging from 0 to 150 mm): desire to eat, hunger, fullness, and prospective food consumption. Appetite sensations will be recorded before, immediately after, and at 10, 20, 30, 40, 50, and 60 minutes after the consumption of the standardized breakfast.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress (cortisol concentrations and perceived stress)</measure>
    <time_frame>At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and for the perceived stress also at 3 months (t=3 mo) after the end of the intervention</time_frame>
    <description>Cortisol concentrations will be measured by three samples of morning salivary taken immediately at the time of awakening as well as 15 minutes and 30 minutes thereafter. The Perceived Stress Scale will be used to measure perceived stress.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating behaviours</measure>
    <time_frame>At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention</time_frame>
    <description>Food craving (Food craving inventory); Cognitive dietary restraint, disinhibition, and susceptibility to hunger (Three factor eating questionnaire); Restrained eating, external eating and emotional eating (Dutch eating behavior questionnaire); Restraint scale; Women's attitude toward their children's eating behaviours (Child feeding questionnaire).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intakes</measure>
    <time_frame>At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention</time_frame>
    <description>A web-based self-administered food frequency questionnaire will be completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention</time_frame>
    <description>Weight will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention</time_frame>
    <description>Waist circumference will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention</time_frame>
    <description>Hip circumference will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention</time_frame>
    <description>Body mass index will be calculated from measured height and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile</measure>
    <time_frame>At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)</time_frame>
    <description>Basic lipid profile will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glycemia</measure>
    <time_frame>At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)</time_frame>
    <description>Fasting glycemia will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting insulinemia</measure>
    <time_frame>At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)</time_frame>
    <description>Fasting insulinemia will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention</time_frame>
    <description>Systolic and diastolic blood pressure will be measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Energy restriction plus CDR group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. They will be told that they are on a low-calorie diet and strategies to increase CDR will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Energy restriction without CDR group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. To have a condition of energy restriction without CDR, they will not be told that they are on a low-calorie diet and non-restrictive messages will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Energy restriction plus CDR</intervention_name>
    <description>Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. In the condition in which an increase in CDR will be induced, women will be told at the beginning of the study and will be reminded throughout the 4-week duration of the experimental condition that they are on a low-calorie diet and that it is important not to eat more than what is provided and that they should strictly avoid non-study food if they want to lose weight and improve their blood pressure. Subjects will receive feedback about their weight trajectory. After the 4-week controlled intervention women will then receive further information and advices to pursue their weight loss on their own and keeping on with strategies relying on an increase in CDR.</description>
    <arm_group_label>Energy restriction plus CDR group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Energy restriction without CDR</intervention_name>
    <description>Subjects will receive the same low-calorie diet (85% of their energy needs) for 4 weeks but will not be told that they are on an energy-deficit diet. They will be told at the beginning of the study that the food provided cover all their nutrient needs and that they should eat until satiation. There will be no emphasis on body weight and subjects will be reminded that the aim of the intervention is to document the effects of a diet rich in vegetables and fruits on blood pressure. After the 4-week controlled diet, participants will be taught about the impact of a low energy density diet on satiation and satiety. They will receive further information and advices (with non-restrictive messages) to incorporate more vegetables and fruits in their usual diet.</description>
    <arm_group_label>Energy restriction without CDR group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal women (age between 20 to 50 years) from de Quebec City metropolitan area&#xD;
&#xD;
          -  Have at least one child (2 to 19 years) living at home&#xD;
&#xD;
          -  Body mass index between 25 and 45 kg/m2&#xD;
&#xD;
          -  Stable body weight (+/- 2,5 kg) for at least 3 months before the beginning of the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with endocrine disorders, cardiovascular events and type 2 diabetes&#xD;
&#xD;
          -  Women with medication that could affect dependent variables measured (namely&#xD;
             medication affecting appetite)&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Women with food allergies or food aversion that could impede compliance to the diet&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Women with psychiatric disorders or eating disorders (e.g. bulimia)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simone Lemieux, Ph.D., Dt.P</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of food sciences and nutrition / Institute of Nutrition and Functional Foods (INAF), Laval University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Nutrition and Functional Foods (INAF), Laval University</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 0A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>August 31, 2015</last_update_submitted>
  <last_update_submitted_qc>August 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Simone Lemieux</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Women</keyword>
  <keyword>Caloric restriction</keyword>
  <keyword>Cognitive dietary restraint</keyword>
  <keyword>Eating behaviours</keyword>
  <keyword>Food habits</keyword>
  <keyword>Appetite sensations</keyword>
  <keyword>Stress</keyword>
  <keyword>Weight management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02230111
org study id: 2013-170
nct id: NCT02230111
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to measure the effects of a reduced-calorie low energy density
      diet with and without increased cognitive dietary restraint (CDR) on stress (biological
      markers and perceived stress), eating behaviours, appetite sensations, anthropometric
      variables and women's attitude toward their children's eating behaviours in premenopausal
      overweight/obese women in both the short term (immediately after the end of the 4-week
      intervention) and longer term (3 months after the end of the intervention). The investigators
      hypothesize that cortisol concentrations are higher, appetite sensations are increased (i.e.
      increased global appetite score) and food cravings are more prevalent in women of the
      energy-restriction-plus-CDR group than in women of the energy-restriction-without-CDR group
      after the 4-week intervention. They also hypothesize that perceived stress is higher and food
      cravings are more prevalent in women of the energy-restriction-plus-CDR group than in women
      of the energy-restriction-without-CDR group at 3-month post intervention. They hypothesize
      that no significant difference in body weight changes is observed between the two groups and
      that maternal restriction of their child's eating is higher in the
      energy-restriction-plus-CDR group than in the energy-restriction-without-CDR group both after
      the 4-week intervention and at the 3-month follow-up.
It is clear that a large proportion of individuals regain weight following dietary weight
      loss interventions most likely because of homeostatic and non-homeostatic factors favouring a
      return to initial energy status. However, studies performed to date have documented these
      effects in the context of interventions favouring both energy restriction and CDR. Thus, the
      difference between a state of energy restriction alone and a state of energy restriction
      combined to CDR on factors regulating energy balance is not known. In order to study this
      important question appropriately, we need to create a condition of energy restriction without
      increasing CDR, which can only be achieved with a satiating diet (i.e. well-balanced low
      energy density diet). This is easier to create in the context of a controlled intervention in
      which all foods and drinks are provided. We propose to create, in a controlled context, an
      energy restriction for which subjects will be blinded i.e. they will consume less energy than
      their energy needs without knowing that they are restrained. Such a design will permit to
      document for the first time the independent effects of CDR in the context of a reduced
      calorie diet on factors associated with the regulation of energy balance. The proposed study
      will also allow exploring the impact of increasing CDR on women's attitude toward their
      children's eating behaviours. Taken all together, results arising from the proposed study
      will better position the relevance of developing weight loss approaches not focusing on CDR
      to favour healthy weight management for women and their family. Data will be collected before
      and after the 4-week intervention, as well as 3 months after the end of the intervention. In
      order to appropriately test our hypotheses, we cannot state the real purpose of the study in
      the informed consent form and women will be told that it is a study about the impact of diet
      on blood pressure. However, at the end of the study, women will be debriefed and will sign a
      second informed consent form in which the true purpose of the study will be explained.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Appetite sensations
time frame: At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)
description: Measurements of appetite sensations will be performed following a standardized meal. After a 12-hour overnight fast, each woman will be invited to eat a standardized breakfast (600 kcal) and to rate her appetite sensations according to 4 visual analog scales (ranging from 0 to 150 mm): desire to eat, hunger, fullness, and prospective food consumption. Appetite sensations will be recorded before, immediately after, and at 10, 20, 30, 40, 50, and 60 minutes after the consumption of the standardized breakfast.
measure: Stress (cortisol concentrations and perceived stress)
time frame: At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and for the perceived stress also at 3 months (t=3 mo) after the end of the intervention
description: Cortisol concentrations will be measured by three samples of morning salivary taken immediately at the time of awakening as well as 15 minutes and 30 minutes thereafter. The Perceived Stress Scale will be used to measure perceived stress.
measure: Eating behaviours
time frame: At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
description: Food craving (Food craving inventory); Cognitive dietary restraint, disinhibition, and susceptibility to hunger (Three factor eating questionnaire); Restrained eating, external eating and emotional eating (Dutch eating behavior questionnaire); Restraint scale; Women's attitude toward their children's eating behaviours (Child feeding questionnaire).
measure: Dietary intakes
time frame: At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
description: A web-based self-administered food frequency questionnaire will be completed.
measure: Weight
time frame: At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
description: Weight will be measured.
measure: Waist circumference
time frame: At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
description: Waist circumference will be measured.
measure: Hip circumference
time frame: At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
description: Hip circumference will be measured.
measure: Body mass index
time frame: At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
description: Body mass index will be calculated from measured height and weight.
measure: Lipid profile
time frame: At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)
description: Basic lipid profile will be measured.
measure: Fasting glycemia
time frame: At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)
description: Fasting glycemia will be measured.
measure: Fasting insulinemia
time frame: At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)
description: Fasting insulinemia will be measured.
measure: Systolic and diastolic blood pressure
time frame: At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
description: Systolic and diastolic blood pressure will be measured.
arm group label: Energy restriction plus CDR group
arm group type: Experimental
description: Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. They will be told that they are on a low-calorie diet and strategies to increase CDR will be used.
arm group label: Energy restriction without CDR group
arm group type: Experimental
description: Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. To have a condition of energy restriction without CDR, they will not be told that they are on a low-calorie diet and non-restrictive messages will be used.
intervention type: Behavioral
intervention name: Energy restriction plus CDR
description: Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. In the condition in which an increase in CDR will be induced, women will be told at the beginning of the study and will be reminded throughout the 4-week duration of the experimental condition that they are on a low-calorie diet and that it is important not to eat more than what is provided and that they should strictly avoid non-study food if they want to lose weight and improve their blood pressure. Subjects will receive feedback about their weight trajectory. After the 4-week controlled intervention women will then receive further information and advices to pursue their weight loss on their own and keeping on with strategies relying on an increase in CDR.
arm group label: Energy restriction plus CDR group
intervention type: Behavioral
intervention name: Energy restriction without CDR
description: Subjects will receive the same low-calorie diet (85% of their energy needs) for 4 weeks but will not be told that they are on an energy-deficit diet. They will be told at the beginning of the study that the food provided cover all their nutrient needs and that they should eat until satiation. There will be no emphasis on body weight and subjects will be reminded that the aim of the intervention is to document the effects of a diet rich in vegetables and fruits on blood pressure. After the 4-week controlled diet, participants will be taught about the impact of a low energy density diet on satiation and satiety. They will receive further information and advices (with non-restrictive messages) to incorporate more vegetables and fruits in their usual diet.
arm group label: Energy restriction without CDR group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Simone Lemieux, Ph.D., Dt.P
role: Principal Investigator
affiliation: Department of food sciences and nutrition / Institute of Nutrition and Functional Foods (INAF), Laval University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Simone Lemieux
investigator title: Professor
mesh term: Overweight