<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/NCT02235038</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00014678</org_study_id>
    <nct_id>NCT02235038</nct_id>
  </id_info>
  <brief_title>Metabolic Fuels Study</brief_title>
  <official_title>A Mechanistic Examination of Dietary Composition on Metabolic Fuels Availability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Framingham State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nutrition Science Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New Balance Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate a potential physiologic mechanism underlying the effects of dietary&#xD;
      composition on control of body weight&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The challenge in maintaining long-term weight loss is well known, however new research&#xD;
      suggests diet quality may be the driving factor. A pilot study from our group demonstrated&#xD;
      that a higher carbohydrate-containing diet was associated with lower total energy expenditure&#xD;
      during weight loss maintenance (Ebbeling et al). These findings will be confirmed in the&#xD;
      ongoing Framingham State Food Study (NCT02068885): Following weight loss on a standard diet,&#xD;
      150 overweight or obese adults (aged 18 to 65 years) will be randomized to one of three&#xD;
      weight-loss maintenance diets varying in carbohydrate to fat ratios for 20 weeks.&#xD;
&#xD;
      However, the specific mechanisms underlying the calorie-independent effects of diet remain&#xD;
      unclear. Another study from our group demonstrated lower energy availability (calculated&#xD;
      based on caloric content of circulating metabolic fuel concentrations) in the fasting and&#xD;
      late post-prandial periods in 8 overweight or obese young adults who were maintained on a&#xD;
      low-fat (high-carbohydrate) diet (Walsh et al). We hypothesize that this lower metabolic fuel&#xD;
      availability on a high carbohydrate diet results in part from increased anabolic changes&#xD;
      within the adipocyte, favoring fat storage in preference to oxidation.&#xD;
&#xD;
      We will invite subjects already enrolled in the Framingham State Food Study to participate,&#xD;
      aiming for a total of 30 subjects (with the goal of approximately equal numbers per diet&#xD;
      group following randomization to assigned test diet in the parent study). Participants will&#xD;
      be admitted to a research unit for a 24-hour period during weight maintenance on the test&#xD;
      diet, during which they will undergo frequent blood sampling for the measurement of&#xD;
      circulating metabolic fuels, hunger and satiety ratings, while consuming their assigned diet&#xD;
      meals. Each participant will also undergo two abdominal subcutaneous fat aspiration biopsies&#xD;
      under local anesthesia, the first immediately following weight loss (before initiating the&#xD;
      test diet) and the second during weight maintenance, in order to perform gene expression&#xD;
      analyses on the adipose tissue. Our main outcomes will be a comparison in energy availability&#xD;
      (the sum of energy in the major metabolic fuels in the blood) between diet groups in the late&#xD;
      postprandial period and changes in adipose tissue gene expression within-individuals and by&#xD;
      diet group assignment. Other outcomes will include differences in hunger and satiety ratings,&#xD;
      total 24-hour energy availability, and specific metabolic fuel concentrations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Late postprandial energy availability</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Post-prandial energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, lactate and ketoacids), as measured during a 24 hr inpatient admission. Time of interest includes 2.5 - 5 hr in the postprandial period after breakfast, lunch and dinner.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Late postprandial energy availability, with lactate excluded</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Post-prandial energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, and ketoacids), as measured during a 24 hr inpatient admission. Time of interest includes 2.5 - 5 hr in the postprandial period after breakfast, lunch and dinner. (Lactate is metabolized primarily by the liver, which uses this substrate to produce glucose. Thus, including lactate in the calculation of metabolic fuels may comprise &quot;double counting&quot; -- and not accurately reflect actual fuel availability to body tissues)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting energy availability</measure>
    <time_frame>10 - 15 weeks after initiation of test diet</time_frame>
    <description>Fasting energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, lactate and ketoacids), as measured during a 24 hr inpatient admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total energy availability</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Total energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, lactate and ketoacids), as measured during a 24 hr inpatient admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hunger</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Measured during a 24 hr inpatient admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satiety</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Measured during a 24 hr inpatient admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Concentration during 24-hr inpatient admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-esterified fatty acids</measure>
    <time_frame>10 - 15 weeks after initiation after test diet</time_frame>
    <description>Concentration during 24-hr inpatient admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lactate</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Concentration during 24-hr inpatient admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ketoacids</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Concentration during 24-hr inpatient admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Concentration during 24-hr inpatient admission</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Effect modification by insulin secretion</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>We will test for an interaction by insulin secretion (as measured by plasma insulin 30 minutes into a standard oral glucose tolerance test) of the relationship between diet and metabolic fuels concentration.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adipocyte studies of anabolic status</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Adipose tissue gene expression studies (assessed by mRNA levels of selected candidate genes involved in lipid storage, fatty acid and lipid biosynthesis, angiogenesis, inflammation). Change from baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adipose tissue histology</measure>
    <time_frame>10 - 15 weeks after initiation of test diets</time_frame>
    <description>Change from baseline.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Low carbohydrate diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate carbohydrate diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High carbohydrate diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low carbohydrate diet</intervention_name>
    <description>Composition (by proportion of calories) : 15% carbohydrate, 65% fat, 20% protein</description>
    <arm_group_label>Low carbohydrate diet</arm_group_label>
    <other_name>Composition : 15% carbohydrate, 65% fat, 20% protein</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Moderate carbohydrate diet</intervention_name>
    <description>Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein</description>
    <arm_group_label>Moderate carbohydrate diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High carbohydrate diet</intervention_name>
    <description>Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein</description>
    <arm_group_label>High carbohydrate diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria (as detailed in Framingham State Food Study, NCT02068885)&#xD;
&#xD;
          -  Aged 18 to 65 years&#xD;
&#xD;
          -  BMI ≥ 25 kg/m2&#xD;
&#xD;
          -  BMI &lt; 40 kg/m2 and weight ≤ 300 lbs (136 kg)&#xD;
&#xD;
          -  Medical clearance from a primary care provider&#xD;
&#xD;
          -  Student or employee at Framingham State University throughout enrollment in the study&#xD;
&#xD;
          -  Willing and able to eat and drink only the foods and beverages on the study menus&#xD;
&#xD;
          -  Willing to eat in the dining hall&#xD;
&#xD;
          -  Willing to abstain from consuming alcohol during participation&#xD;
&#xD;
        Additional Inclusion Criteria:&#xD;
&#xD;
        • Willing to undergo additional procedures in this ancillary study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria (as detailed in Framingham State Food Study, NCT02068885)&#xD;
&#xD;
          -  Change in body weight exceeding ±10% during prior year&#xD;
&#xD;
          -  Recent adherence to a special diet&#xD;
&#xD;
          -  Recent adherence to a vigorous physical activity regimen (e.g., participation in a&#xD;
             varsity sport)&#xD;
&#xD;
          -  Chronic use of any medication or dietary supplement that could affect study outcomes&#xD;
&#xD;
          -  Current smoking (1 cigarette in the last week)&#xD;
&#xD;
          -  Heavy baseline alcohol consumption or history of binge drinking&#xD;
&#xD;
          -  Physician diagnosis of a major medical/psychiatric illness or eating disorder&#xD;
&#xD;
          -  Abnormal blood glucose, TSH, CBC, BUN, Creatinine&#xD;
&#xD;
          -  ALT greater than 150% of the normal upper limit&#xD;
&#xD;
          -  Plans for a vacation during the study that would preclude adherence to prescribed diet&#xD;
&#xD;
          -  Additional exclusions for female participants: Irregular menstrual cycles; any change&#xD;
             in birth control medication during the 3 months prior to enrollment; pregnancy or&#xD;
             lactation during the 12 months prior to enrollment&#xD;
&#xD;
        Additional Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or prior reaction to Lidocaine&#xD;
&#xD;
          -  Medical condition or medication that would increase risk of bleeding, infection or&#xD;
             skin reactions&#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>Kim Shams, MD</last_name>
    <role>Study Director</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David s Ludwig, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cara B Ebbeling, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Framingham State University</name>
      <address>
        <city>Framingham</city>
        <state>Massachusetts</state>
        <zip>01702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Walsh CO, Ebbeling CB, Swain JF, Markowitz RL, Feldman HA, Ludwig DS. Effects of diet composition on postprandial energy availability during weight loss maintenance. PLoS One. 2013;8(3):e58172. doi: 10.1371/journal.pone.0058172. Epub 2013 Mar 6.</citation>
    <PMID>23483989</PMID>
  </reference>
  <reference>
    <citation>Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607.</citation>
    <PMID>22735432</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>David S. Ludwig, MD, PhD</investigator_full_name>
    <investigator_title>Director, Obesity Prevention Center</investigator_title>
  </responsible_party>
  <!-- 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/NCT02235038
org study id: IRB-P00014678
nct id: NCT02235038
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study will evaluate a potential physiologic mechanism underlying the effects of dietary
      composition on control of body weight
The challenge in maintaining long-term weight loss is well known, however new research
      suggests diet quality may be the driving factor. A pilot study from our group demonstrated
      that a higher carbohydrate-containing diet was associated with lower total energy expenditure
      during weight loss maintenance (Ebbeling et al). These findings will be confirmed in the
      ongoing Framingham State Food Study (NCT02068885): Following weight loss on a standard diet,
      150 overweight or obese adults (aged 18 to 65 years) will be randomized to one of three
      weight-loss maintenance diets varying in carbohydrate to fat ratios for 20 weeks.

      However, the specific mechanisms underlying the calorie-independent effects of diet remain
      unclear. Another study from our group demonstrated lower energy availability (calculated
      based on caloric content of circulating metabolic fuel concentrations) in the fasting and
      late post-prandial periods in 8 overweight or obese young adults who were maintained on a
      low-fat (high-carbohydrate) diet (Walsh et al). We hypothesize that this lower metabolic fuel
      availability on a high carbohydrate diet results in part from increased anabolic changes
      within the adipocyte, favoring fat storage in preference to oxidation.

      We will invite subjects already enrolled in the Framingham State Food Study to participate,
      aiming for a total of 30 subjects (with the goal of approximately equal numbers per diet
      group following randomization to assigned test diet in the parent study). Participants will
      be admitted to a research unit for a 24-hour period during weight maintenance on the test
      diet, during which they will undergo frequent blood sampling for the measurement of
      circulating metabolic fuels, hunger and satiety ratings, while consuming their assigned diet
      meals. Each participant will also undergo two abdominal subcutaneous fat aspiration biopsies
      under local anesthesia, the first immediately following weight loss (before initiating the
      test diet) and the second during weight maintenance, in order to perform gene expression
      analyses on the adipose tissue. Our main outcomes will be a comparison in energy availability
      (the sum of energy in the major metabolic fuels in the blood) between diet groups in the late
      postprandial period and changes in adipose tissue gene expression within-individuals and by
      diet group assignment. Other outcomes will include differences in hunger and satiety ratings,
      total 24-hour energy availability, and specific metabolic fuel concentrations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Late postprandial energy availability
time frame: 10 - 15 weeks after initiation of test diets
description: Post-prandial energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, lactate and ketoacids), as measured during a 24 hr inpatient admission. Time of interest includes 2.5 - 5 hr in the postprandial period after breakfast, lunch and dinner.
measure: Late postprandial energy availability, with lactate excluded
time frame: 10 - 15 weeks after initiation of test diets
description: Post-prandial energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, and ketoacids), as measured during a 24 hr inpatient admission. Time of interest includes 2.5 - 5 hr in the postprandial period after breakfast, lunch and dinner. (Lactate is metabolized primarily by the liver, which uses this substrate to produce glucose. Thus, including lactate in the calculation of metabolic fuels may comprise "double counting" -- and not accurately reflect actual fuel availability to body tissues)
measure: Fasting energy availability
time frame: 10 - 15 weeks after initiation of test diet
description: Fasting energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, lactate and ketoacids), as measured during a 24 hr inpatient admission.
measure: Total energy availability
time frame: 10 - 15 weeks after initiation of test diets
description: Total energy availability calculated as the sum, in kcal/L, of energy from circulating metabolic fuels (glucose, non-esterified fatty acids, lactate and ketoacids), as measured during a 24 hr inpatient admission.
measure: Hunger
time frame: 10 - 15 weeks after initiation of test diets
description: Measured during a 24 hr inpatient admission.
measure: Satiety
time frame: 10 - 15 weeks after initiation of test diets
description: Measured during a 24 hr inpatient admission.
measure: Glucose
time frame: 10 - 15 weeks after initiation of test diets
description: Concentration during 24-hr inpatient admission
measure: Non-esterified fatty acids
time frame: 10 - 15 weeks after initiation after test diet
description: Concentration during 24-hr inpatient admission
measure: Lactate
time frame: 10 - 15 weeks after initiation of test diets
description: Concentration during 24-hr inpatient admission
measure: Ketoacids
time frame: 10 - 15 weeks after initiation of test diets
description: Concentration during 24-hr inpatient admission
measure: Insulin
time frame: 10 - 15 weeks after initiation of test diets
description: Concentration during 24-hr inpatient admission
measure: Effect modification by insulin secretion
time frame: 10 - 15 weeks after initiation of test diets
description: We will test for an interaction by insulin secretion (as measured by plasma insulin 30 minutes into a standard oral glucose tolerance test) of the relationship between diet and metabolic fuels concentration.
measure: Adipocyte studies of anabolic status
time frame: 10 - 15 weeks after initiation of test diets
description: Adipose tissue gene expression studies (assessed by mRNA levels of selected candidate genes involved in lipid storage, fatty acid and lipid biosynthesis, angiogenesis, inflammation). Change from baseline.
measure: Adipose tissue histology
time frame: 10 - 15 weeks after initiation of test diets
description: Change from baseline.
arm group label: Low carbohydrate diet
arm group type: Active Comparator
arm group label: Moderate carbohydrate diet
arm group type: Active Comparator
arm group label: High carbohydrate diet
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Low carbohydrate diet
description: Composition (by proportion of calories) : 15% carbohydrate, 65% fat, 20% protein
arm group label: Low carbohydrate diet
other name: Composition : 15% carbohydrate, 65% fat, 20% protein
intervention type: Behavioral
intervention name: Moderate carbohydrate diet
description: Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
arm group label: Moderate carbohydrate diet
intervention type: Behavioral
intervention name: High carbohydrate diet
description: Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
arm group label: High carbohydrate diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kim Shams, MD
role: Study Director
affiliation: Boston Children's Hospital
last name: David s Ludwig, MD, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Cara B Ebbeling, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Walsh CO, Ebbeling CB, Swain JF, Markowitz RL, Feldman HA, Ludwig DS. Effects of diet composition on postprandial energy availability during weight loss maintenance. PLoS One. 2013;8(3):e58172. doi: 10.1371/journal.pone.0058172. Epub 2013 Mar 6.
PMID: 23483989
citation: Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607.
PMID: 22735432
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: David S. Ludwig, MD, PhD
investigator title: Director, Obesity Prevention Center