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Dyad Plus Effectiveness

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ClinicalTrials.gov Identifier: NCT04036331
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of this research is to determine the effectiveness of 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.

Condition or disease Intervention/treatment Phase
Weight Loss Pediatric Obesity Overweight Adolescents Parent-Child Relations Family and Household Behavioral: Brenner FIT Standard Behavioral: By Design Essentials Behavioral: Dyad Plus Not Applicable

Detailed Description:

Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity. 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.

Participants will be randomized into 1 of 3 groups. This include Brenner FIT standard care, Brenner FIT standard care+ By Design Essentials, or Dyad Plus.

Brenner FIT Standard: After referral, families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and physical activity specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, physical activity, and parenting. Specialized visits with the physical activity specialist or dietician are scheduled as pertinent issues arise. Clinic visits include individualized goal setting (for behaviors family/clinician have agreed to address), healthy eating and physical activity education, and behavioral counseling to implement changes at home.

By Design Essentials: A dietitian provides each participant with a detailed program manual that describes the prescribed diet. The dietitian utilizes standard behavioral techniques to promote lifestyle behavior changes that enable participants to implement and maintain behaviors necessary to adhere to the dietary prescription. Participants also receive a standard exercise program designed to promote exercise energy expenditure of approximately 600 kilocalories*/week. The exercise prescription includes resistance training for 2 days per week and aerobic training for 3 days per week, to meet a 600 kilocalories*/week expenditure goal. Behaviorists meet with participants to provide individual and group-based counseling to learn the skills necessary to adopt the prescribed dietary pattern and exercise plans. Group sessions will be delivered consecutively over 6 months (20 total; 1.5 hours each).

Dyad Plus (combination of Brenner FIT and By Design Essentials):This will include all components of the standard Brenner FIT program and By Design Essentials. In addition, group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. Dyads will attend 6 meetings that will last approximately 1 hour each.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of A Coordinated Parent/Child Dyad Weight Loss Intervention:
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Adolescent Participants
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.
Behavioral: Brenner FIT Standard
After referral, families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and physical activity specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, physical activity, and parenting. Specialized visits with the physical activity specialist or dietician are scheduled as pertinent issues arise. Clinic visits include individualized goal setting (for behaviors family/clinician have agreed to address), healthy eating and physical activity education, and behavioral counseling to implement changes at home.

Experimental: Caregivers of Adolescent Participants
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.
Behavioral: By Design Essentials
A dietitian provides each participant with a detailed program manual that describes the prescribed diet. The dietitian utilizes standard behavioral techniques to promote lifestyle behavior changes that enable participants to implement and maintain behaviors necessary to adhere to the dietary prescription. Participants also receive a standard exercise program designed to promote exercise energy expenditure of approximately 600 kilocalories*/week. The exercise prescription includes resistance training for 2 days per week and aerobic training for 3 days per week, to meet a 600 kilocalories*/week expenditure goal. Behaviorists meet with participants to provide individual and group-based counseling to learn the skills necessary to adopt the prescribed dietary pattern and exercise plans. Group sessions will be delivered consecutively over 6 months (20 total; 1.5 hours each).

Experimental: Co-enrollment
This condition is for dyads that are co-enrolled in 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.
Behavioral: Dyad Plus

This will include all components of the standard Brenner FIT program and By Design Essentials.

In addition, group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. Dyads will attend 6 meetings that will last approximately 1 hour each.





Primary Outcome Measures :
  1. BMI z-score [ Time Frame: Baseline ]
    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.

  2. BMI z-score [ Time Frame: 3 months ]
    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.

  3. BMI z-score [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Physical Activity Assessed by Accelerometry [ Time Frame: Baseline ]
    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.

  2. Physical Activity Assessed by Accelerometry [ Time Frame: 3 months ]
    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.

  3. Physical Activity Assessed by Accelerometry [ Time Frame: 6 months ]
    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.

  4. Physical Activity Assessed by PAQ-A [ Time Frame: Baseline ]

    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.


  5. Physical Activity Assessed by PAQ-A [ Time Frame: 6 months ]

    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.


  6. Physical Activity Assessed by IPAQ [ Time Frame: Baseline ]

    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.


  7. Physical Activity Assessed by IPAQ [ Time Frame: 6 months ]

    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.


  8. Caloric intake expressed in kcals [ Time Frame: Baseline ]
    Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.

  9. Caloric intake expressed in kcals [ Time Frame: 6 months ]
    Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.

  10. Concentration of fasting glucose for all participants, mg/dL [ Time Frame: Baseline ]
    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.

  11. Concentration of fasting glucose for all participants, mg/dL [ Time Frame: 6 months ]
    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.

  12. Concentration of fasting Insulin for all participants, mg/dL [ Time Frame: Baseline ]
    Fasting insulin levels will be gathered from all participants.

  13. Concentration of fasting Insulin for all participants, mg/dL [ Time Frame: 6 months ]
    Fasting insulin levels will be gathered from all participants.

  14. Hemoglobin A1c concentration for all participants, measured in percentage [ Time Frame: Baseline ]
    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.

  15. Hemoglobin A1c concentration for all participants, measured in percentage [ Time Frame: 6 months ]
    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.

  16. Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L) [ Time Frame: Baseline ]
    AST a useful test for detecting or monitoring liver damage.

  17. Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L) [ Time Frame: 6 months ]
    AST a useful test for detecting or monitoring liver damage.

  18. Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter [ Time Frame: Baseline ]
    A low level of ALT in the blood is expected and is normal.

  19. Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter [ Time Frame: 6 months ]
    A low level of ALT in the blood is expected and is normal.

  20. Concentration of total cholesterol (mg/dL) [ Time Frame: Baseline ]
    total cholesterol: less than 200 mg/dL

  21. Concentration of total cholesterol (mg/dL) [ Time Frame: 6 months ]
    total cholesterol: less than 200 mg/dL

  22. Economic costs of the three intervention arms over duration of program (USD) [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for enrollment in Brenner FIT and/or By Design Essentials
  • Caregiver who lives in the house with a BMI > 30
  • No contraindication for physical activity or caloric restriction
  • Must be able to read and write English

Exclusion Criteria:

  • BMI < 30
  • Contraindication for physical activity or caloric restriction
  • Cannot read or write English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036331


Contacts
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Contact: Camelia R Singletary, MPH 13369992469 crsingle@wakehealth.edu
Contact: Justin Moore, PhD 336-716-3702 jusmoore@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27127
Contact: Justin Moore    336-716-3702    jusmoore@wakehealth.edu   
Contact: Camelia R Singletary    13369992469    crsingle@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Justin Moore Wake Forest University Health Sciences
Publications:
Djafarian K, Speakman JR, Stewart J, Jackson DM. Comparison of activity levels measured by a wrist worn accelerometer and direct observation in young children. Open Journal of Pediatrics. 2013;03(04):422-427.
Chandler JL, Beets MW, Drenowatz C, et al. Analysis of Accelerometer Counts during Sedentary Activities on Dominant and Non-Dominant Wrists in 5-11 year old Children. Under review.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04036331    
Other Study ID Numbers: IRB00059569
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Overweight
Weight Loss
Body Weight
Body Weight Changes
Obesity
Overnutrition
Nutrition Disorders