<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/NCT03811743</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00055004</org_study_id>
    <nct_id>NCT03811743</nct_id>
  </id_info>
  <brief_title>A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)</brief_title>
  <official_title>A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this research is to develop a coordinated program (Dyad Plus) that would help&#xD;
      to facilitate self-monitoring, positive communication, joint problem solving, and social&#xD;
      support to increase physical activity, healthy eating, and weight loss. Participants of the&#xD;
      Brenner FIT (Families In Training) pediatric weight management program and their&#xD;
      parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the&#xD;
      components of By Design Essentials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participation in this study will involve participation in six, one-hour sessions in addition&#xD;
      to those required by your weight loss program. These sessions will work to facilitate an&#xD;
      increase in self-monitoring, positive communication, problem solving, and social support to&#xD;
      increase healthy physical activity and eating behaviors to increase the effectiveness of the&#xD;
      weight loss programs. Joint goal setting and tracking will be enabled by commercially&#xD;
      available devices and apps. Each caregiver and child will receive an activity monitor,&#xD;
      activity app, and a food app (digital food diary) that allows self-monitoring of consumption&#xD;
      and &quot;social accountability,&quot; which will allow caregivers and the Brenner FIT team to monitor&#xD;
      and encourage. Furthermore, two home visits will be conducted to evaluation the home food and&#xD;
      activity environments to inform tailored feedback to families.&#xD;
&#xD;
      Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old&#xD;
      referred by a physician for overweight or obesity.11-14 By Design is an adult (&gt;18yrs) weight&#xD;
      loss clinic that includes tailored dietary and physical activity behavioral counseling. The&#xD;
      preliminary data suggest that most adolescent youth who enroll in Brenner FIT have at least&#xD;
      one adult caregiver who is eligible and would benefit from enrollment in By Design&#xD;
      Essentials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2020</start_date>
  <completion_date type="Actual">June 16, 2020</completion_date>
  <primary_completion_date type="Actual">June 16, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI z-score</measure>
    <time_frame>Baseline</time_frame>
    <description>Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI z-score</measure>
    <time_frame>3 Months</time_frame>
    <description>Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI z-score</measure>
    <time_frame>6 months</time_frame>
    <description>Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Assessed by Accelerometry</measure>
    <time_frame>Baseline</time_frame>
    <description>Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Assessed by Accelerometry</measure>
    <time_frame>6 months</time_frame>
    <description>Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Assessed by PAQ-A</measure>
    <time_frame>Baseline</time_frame>
    <description>The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity.&#xD;
The PAQ-A ranges from 1-7. Higher score denotes better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Assessed by PAQ-A</measure>
    <time_frame>6 months</time_frame>
    <description>The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity.&#xD;
The PAQ-A ranges from 1-7. Higher score denotes better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Assessed by IPAQ</measure>
    <time_frame>Baseline</time_frame>
    <description>The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults.&#xD;
The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Assessed by IPAQ</measure>
    <time_frame>6 months</time_frame>
    <description>The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults.&#xD;
The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caloric intake expressed in kcals</measure>
    <time_frame>Baseline</time_frame>
    <description>Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caloric intake expressed in kcals</measure>
    <time_frame>6 months</time_frame>
    <description>Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of fasting glucose for all participants, mg/dL</measure>
    <time_frame>Baseline</time_frame>
    <description>Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of fasting glucose for all participants, mg/dL</measure>
    <time_frame>6 months</time_frame>
    <description>Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of fasting Insulin for all participants, mg/dL</measure>
    <time_frame>Baseline</time_frame>
    <description>Fasting insulin levels will be gathered from all participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of fasting Insulin for all participants, mg/dL</measure>
    <time_frame>6 months</time_frame>
    <description>Fasting insulin levels will be gathered from all participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c concentration for all participants, measured in percentage</measure>
    <time_frame>Baseline</time_frame>
    <description>Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% Values greater denote diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c concentration for all participants, measured in percentage</measure>
    <time_frame>6 months</time_frame>
    <description>Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4%. Values greater denote diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)</measure>
    <time_frame>Baseline</time_frame>
    <description>AST a useful test for detecting or monitoring liver damage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)</measure>
    <time_frame>6 months</time_frame>
    <description>AST a useful test for detecting or monitoring liver damage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter</measure>
    <time_frame>Baseline</time_frame>
    <description>A low level of ALT in the blood is expected and is normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter</measure>
    <time_frame>6 months</time_frame>
    <description>A low level of ALT in the blood is expected and is normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of total cholesterol (mg/dL)</measure>
    <time_frame>Baseline</time_frame>
    <description>total cholesterol: less than 200 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of total cholesterol (mg/dL)</measure>
    <time_frame>6 months</time_frame>
    <description>total cholesterol: less than 200 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic costs of the three intervention arms over duration of program (USD)</measure>
    <time_frame>Baseline through 6 months</time_frame>
    <description>Clinical and non-clinical costs of the interventions will be compiled over the duration of the program. All cost will be reported in the same unit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Weight Loss</condition>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Adolescents Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescents will participate in the Dyad Plus program along with their caregivers. The Dyad plus program consist of the combination of two existing programs (Brenner FIT for adolescents and By Design for the adult caregivers) with a new, novel coordination component</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers of adolescents participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult caregivers will participate in the Dyad Plus program along with their youth participants. The Dyad plus program consist of the combination of two existing programs (Brenner FIT for adolescents and By Design for the adult caregivers) with a new, novel coordination component</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brenner FIT</intervention_name>
    <description>Brenner FIT pediatric weight management program enrollment. an interdisciplinary, family-based pediatric weight management clinic based upon the Familial Approach to Treatment of Childhood Obesity. Patients are referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are comprised of a pediatrician, counselor, dietitian, and physical activity specialist, with others (e.g., social workers, physical therapists) as needed. The entire family is encouraged to attend all aspects of the treatment program, although only one attending caregiver is required.</description>
    <arm_group_label>Adolescents Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>By Design</intervention_name>
    <description>Weight loss program for adults/caregivers of those enrolled in Brenner FIT. Participants in the By Design condition (adult caregivers) will be prescribed the Essentials lifestyle intervention which includes tailored dietary and physical activity goals designed to achieve 1-2 lbs./week of weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie restriction of 500 kcal/day is prescribed based on estimates of total energy expenditure (TEE) obtained from a measured resting metabolic rate (RMR) prior to enrollment.</description>
    <arm_group_label>Caregivers of adolescents participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coordination</intervention_name>
    <description>This component adds four additional strategies: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. This innovative approach will seek to employ components of motivation and communication theories to increase self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs beyond gains observed in matched controls.&#xD;
Essentials (adults), with four additional components: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment</description>
    <arm_group_label>Adolescents Participants</arm_group_label>
    <arm_group_label>Caregivers of adolescents participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for enrollment in Brenner FIT and/or By Design Essentials&#xD;
&#xD;
          -  Caregiver who lives in the house with a BMI &gt; 30&#xD;
&#xD;
          -  No contraindication for physical activity or caloric restriction&#xD;
&#xD;
          -  Must be able to read and write English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Over the age of 65&#xD;
&#xD;
          -  BMI &lt; 30&#xD;
&#xD;
          -  Contraindication for physical activity or caloric restriction&#xD;
&#xD;
          -  Cannot read or write English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justin Moore, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Skelton JA, Beech BM. Attrition in paediatric weight management: a review of the literature and new directions. Obes Rev. 2011 May;12(5):e273-81. doi: 10.1111/j.1467-789X.2010.00803.x. Epub 2010 Sep 29.</citation>
    <PMID>20880126</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Youth</keyword>
  <keyword>Parents</keyword>
  <keyword>Overweight</keyword>
  <keyword>Families</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03811743/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03811743
org study id: IRB00055004
nct id: NCT03811743
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to develop a coordinated program (Dyad Plus) that would help
      to facilitate self-monitoring, positive communication, joint problem solving, and social
      support to increase physical activity, healthy eating, and weight loss. Participants of the
      Brenner FIT (Families In Training) pediatric weight management program and their
      parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the
      components of By Design Essentials.
Participation in this study will involve participation in six, one-hour sessions in addition
      to those required by your weight loss program. These sessions will work to facilitate an
      increase in self-monitoring, positive communication, problem solving, and social support to
      increase healthy physical activity and eating behaviors to increase the effectiveness of the
      weight loss programs. Joint goal setting and tracking will be enabled by commercially
      available devices and apps. Each caregiver and child will receive an activity monitor,
      activity app, and a food app (digital food diary) that allows self-monitoring of consumption
      and "social accountability," which will allow caregivers and the Brenner FIT team to monitor
      and encourage. Furthermore, two home visits will be conducted to evaluation the home food and
      activity environments to inform tailored feedback to families.

      Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old
      referred by a physician for overweight or obesity.11-14 By Design is an adult (>18yrs) weight
      loss clinic that includes tailored dietary and physical activity behavioral counseling. The
      preliminary data suggest that most adolescent youth who enroll in Brenner FIT have at least
      one adult caregiver who is eligible and would benefit from enrollment in By Design
      Essentials.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BMI z-score
time frame: Baseline
description: Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.
measure: BMI z-score
time frame: 3 Months
description: Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.
measure: BMI z-score
time frame: 6 months
description: Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.
measure: Physical Activity Assessed by Accelerometry
time frame: Baseline
description: Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.
measure: Physical Activity Assessed by Accelerometry
time frame: 6 months
description: Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.
measure: Physical Activity Assessed by PAQ-A
time frame: Baseline
description: The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity.
The PAQ-A ranges from 1-7. Higher score denotes better outcome.
measure: Physical Activity Assessed by PAQ-A
time frame: 6 months
description: The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity.
The PAQ-A ranges from 1-7. Higher score denotes better outcome.
measure: Physical Activity Assessed by IPAQ
time frame: Baseline
description: The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults.
The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.
measure: Physical Activity Assessed by IPAQ
time frame: 6 months
description: The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults.
The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.
measure: Caloric intake expressed in kcals
time frame: Baseline
description: Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
measure: Caloric intake expressed in kcals
time frame: 6 months
description: Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
measure: Concentration of fasting glucose for all participants, mg/dL
time frame: Baseline
description: Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.
measure: Concentration of fasting glucose for all participants, mg/dL
time frame: 6 months
description: Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.
measure: Concentration of fasting Insulin for all participants, mg/dL
time frame: Baseline
description: Fasting insulin levels will be gathered from all participants.
measure: Concentration of fasting Insulin for all participants, mg/dL
time frame: 6 months
description: Fasting insulin levels will be gathered from all participants.
measure: Hemoglobin A1c concentration for all participants, measured in percentage
time frame: Baseline
description: Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% Values greater denote diabetes.
measure: Hemoglobin A1c concentration for all participants, measured in percentage
time frame: 6 months
description: Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4%. Values greater denote diabetes.
measure: Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
time frame: Baseline
description: AST a useful test for detecting or monitoring liver damage.
measure: Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
time frame: 6 months
description: AST a useful test for detecting or monitoring liver damage.
measure: Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
time frame: Baseline
description: A low level of ALT in the blood is expected and is normal.
measure: Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
time frame: 6 months
description: A low level of ALT in the blood is expected and is normal.
measure: Concentration of total cholesterol (mg/dL)
time frame: Baseline
description: total cholesterol: less than 200 mg/dL
measure: Concentration of total cholesterol (mg/dL)
time frame: 6 months
description: total cholesterol: less than 200 mg/dL
measure: Economic costs of the three intervention arms over duration of program (USD)
time frame: Baseline through 6 months
description: Clinical and non-clinical costs of the interventions will be compiled over the duration of the program. All cost will be reported in the same unit.
arm group label: Adolescents Participants
arm group type: Experimental
description: Adolescents will participate in the Dyad Plus program along with their caregivers. The Dyad plus program consist of the combination of two existing programs (Brenner FIT for adolescents and By Design for the adult caregivers) with a new, novel coordination component
arm group label: Caregivers of adolescents participants
arm group type: Experimental
description: Adult caregivers will participate in the Dyad Plus program along with their youth participants. The Dyad plus program consist of the combination of two existing programs (Brenner FIT for adolescents and By Design for the adult caregivers) with a new, novel coordination component
intervention type: Behavioral
intervention name: Brenner FIT
description: Brenner FIT pediatric weight management program enrollment. an interdisciplinary, family-based pediatric weight management clinic based upon the Familial Approach to Treatment of Childhood Obesity. Patients are referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are comprised of a pediatrician, counselor, dietitian, and physical activity specialist, with others (e.g., social workers, physical therapists) as needed. The entire family is encouraged to attend all aspects of the treatment program, although only one attending caregiver is required.
arm group label: Adolescents Participants
intervention type: Behavioral
intervention name: By Design
description: Weight loss program for adults/caregivers of those enrolled in Brenner FIT. Participants in the By Design condition (adult caregivers) will be prescribed the Essentials lifestyle intervention which includes tailored dietary and physical activity goals designed to achieve 1-2 lbs./week of weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie restriction of 500 kcal/day is prescribed based on estimates of total energy expenditure (TEE) obtained from a measured resting metabolic rate (RMR) prior to enrollment.
arm group label: Caregivers of adolescents participants
intervention type: Behavioral
intervention name: Coordination
description: This component adds four additional strategies: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. This innovative approach will seek to employ components of motivation and communication theories to increase self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs beyond gains observed in matched controls.
Essentials (adults), with four additional components: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment
arm group label: Adolescents Participants
arm group label: Caregivers of adolescents participants
criteria: 
gender: All
minimum age: 13 Years
maximum age: 65 Years
healthy volunteers: No
last name: Justin Moore, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
citation: Skelton JA, Beech BM. Attrition in paediatric weight management: a review of the literature and new directions. Obes Rev. 2011 May;12(5):e273-81. doi: 10.1111/j.1467-789X.2010.00803.x. Epub 2010 Sep 29.
PMID: 20880126
responsible party type: Sponsor
mesh term: Pediatric Obesity
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No
provided document: 