Dyad Plus Effectiveness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of A Coordinated Parent/Child Dyad Weight Loss Intervention:

Conditions
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Weight Loss, Pediatric Obesity, Overweight Adolescents, Parent-Child Relations, Family and Household

Intervention / Treatment
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* Behavioral: Brenner FIT Standard
* Behavioral: By Design Essentials
* Behavioral: Dyad Plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adolescent Participants<br>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<br>* 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.<br>|
| Experimental: Caregivers of Adolescent Participants<br>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<br>* 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).<br>|
| Experimental: Co-enrollment<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z-score | 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. | Baseline | 
| BMI z-score | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Assessed by Accelerometry | 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. | Baseline | 
| Physical Activity Assessed by Accelerometry | 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. | 6 months | 
| Physical Activity Assessed by PAQ-A | 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. | Baseline | 
| Physical Activity Assessed by PAQ-A | 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 months | 
| Physical Activity Assessed by IPAQ | 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. | Baseline | 
| Physical Activity Assessed by IPAQ | 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. | 6 months | 
| Caloric intake expressed in kcals | Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool. | Baseline | 
| Caloric intake expressed in kcals | Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool. | 6 months | 
| Concentration of fasting glucose for all participants, mg/dL | 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. | Baseline | 
| Concentration of fasting glucose for all participants, mg/dL | 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. | 6 months | 
| Concentration of fasting Insulin for all participants, mg/dL | Fasting insulin levels will be gathered from all participants. | Baseline | 
| Concentration of fasting Insulin for all participants, mg/dL | Fasting insulin levels will be gathered from all participants. | 6 months | 
| Hemoglobin A1c concentration for all participants, measured in percentage | 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. | Baseline | 
| Hemoglobin A1c concentration for all participants, measured in percentage | 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. | 6 months | 
| Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L) | AST a useful test for detecting or monitoring liver damage. | Baseline | 
| Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L) | AST a useful test for detecting or monitoring liver damage. | 6 months | 
| Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter | A low level of ALT in the blood is expected and is normal. | Baseline | 
| Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter | A low level of ALT in the blood is expected and is normal. | 6 months | 
| Concentration of total cholesterol (mg/dL) | total cholesterol: less than 200 mg/dL | Baseline | 
| Concentration of total cholesterol (mg/dL) | total cholesterol: less than 200 mg/dL | 6 months | 
| Economic costs of the three intervention arms over duration of program (USD) | 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. | 6 months |