Weight LossNCT04036331
Dyad Plus Effectiveness/Feasibility
A study testing Brenner FIT Standard, By Design Essentials and Dyad Plus in people with Weight Loss and Pediatric Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Weight Loss, Pediatric Obesity, Overweight Adolescents
- What is being tested?
- Brenner FIT Standard, By Design Essentials and Dyad Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2021to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- BMI < 30
- Contraindication for physical activity or caloric restriction
- Cannot read or write English
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27127
About this study
Official title: Effectiveness/Feasibility of A Coordinated Parent/Child Dyad Weight Loss Intervention:
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.
Read the 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.
- Conditions
- Weight Loss, Pediatric Obesity, Overweight Adolescents, Parent-Child Relations, Family and Household
- Being tested
- Brenner FIT Standard, By Design Essentials, Dyad Plus
- Medical subject headings
- Weight Loss, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brenner FIT StandardBehavioural
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 EssentialsBehavioural
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 PlusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Participants | Active comparator | 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. Receives: Behavioral: Brenner FIT Standard |
| Caregivers of Adolescent Participants | Experimental | 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. Receives: Behavioral: By Design Essentials |
| Co-enrollment | Experimental | 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. Receives: Behavioral: Dyad Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Feasibility and Acceptability of Implementation
We will examine screening, recruitment, retention, adherence, and overall perception of Brenner FIT and By Design components
Measured: Month 6
Secondary outcomes (20)
Physical Activity Assessment Tool (PAAT)-Adult
Physical activity data will be collected using the Physical Activity Assessment Tool (PAAT). The PAAT measures type, frequency, and duration of moderate and vigorous physical activity from all four domains of physical activity-leisure, occupational, household, and transportation-in the last 7 days, and asks if this is "more, less, or about the same as usual" activity
Measured: Baseline
Physical Activity Assessment Tool (PAAT)-Adult
Physical activity data will be collected using the Physical Activity Assessment Tool (PAAT). The PAAT measures type, frequency, and duration of moderate and vigorous physical activity from all four domains of physical activity-leisure, occupational, household, and transportation-in the last 7 days, and asks if this is "more, less, or about the same as usual" activity
Measured: 6 Months
Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)
Physical activity data will be collected using the Youth Physical Activity Questionnaire (YPAQ which contains 47 different activities broken into contextual settings/domains: sporting, leisure, school, and free-time activities and aims to measures frequency, duration, intensity, and mode, over the past 7 days of both PA and sedentary activities. The questionnaire will be self-administered via a REDCap survey. Study staff will be available to answer any questions that participants have during the process.
Measured: Baseline
Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)
Physical activity data will be collected using the Youth Physical Activity Questionnaire (YPAQ which contains 47 different activities broken into contextual settings/domains: sporting, leisure, school, and free-time activities and aims to measures frequency, duration, intensity, and mode, over the past 7 days of both PA and sedentary activities. The questionnaire will be self-administered via a REDCap survey. Study staff will be available to answer any questions that participants have during the process.
Measured: 6 months
Physical Activity Assessed Using Fitbit (Youth)
In addition to using the YPAQ, physical activity data will be collected using Fitbit Inspire 2 (Model Number: FB418BKBK). Participating children will be instructed to wear the Fitbit device for 7 days continuously during the two data collection timepoints (baseline and 6 months).
Measured: Baseline
Physical Activity Assessed Using Fitbit (Youth)
In addition to using the YPAQ, physical activity data will be collected using Fitbit Inspire 2 (Model Number: FB418BKBK). Participating children will be instructed to wear the Fitbit device for 7 days continuously during the two data collection timepoints (baseline and 6 months).
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: Baseline
Concentration of fasting Insulin for all participants, mg/dL
Fasting insulin levels will be gathered from all participants. ONLY if routinely collected as a part of regular clinical care.
Measured: Baseline
Concentration of fasting Insulin for all participants, mg/dL
Fasting insulin levels will be gathered from all participants. ONLY if routinely collected as a part of regular clinical care.
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: 6 months
Concentration of total cholesterol (mg/dL)
total cholesterol: less than 200 mg/dL.ONLY if routinely collected as a part of regular clinical care.
Measured: Baseline
Concentration of total cholesterol (mg/dL)
total cholesterol: less than 200 mg/dL. ONLY if routinely collected as a part of regular clinical care.
Measured: 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. ONLY if routinely collected as a part of regular clinical care.
Measured: Month 6
Diet for Parent and Youth
To assess diet in participant, we will use the NCI's NHANES Food Frequency Questionnaire which aims to obtain frequency and, in some cases, portion size information about food and beverage consumption over a specified period of time, typically the past month or year. A food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. The questionnaire will be self-administered via a REDCap survey. Study staff will be available to answer any questions that participants have during the process.
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start30 Jul 2021
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Justin Moore, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036331
- Sponsor's protocol ID
- IRB00059569
- Other IDs
- 40010565
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kelly T, Yang W, Chen CS, Reynolds K, He J. Global burden of obesity in 2005 and projections to 2030. Int J Obes (Lond). 2008 Sep;32(9):1431-7. doi: 10.1038/ijo.2008.102. Epub 2008 Jul 8.
PubMed 18607383Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244Ogden CL, Carroll MD, Lawman HG, Fryar CD, Kruszon-Moran D, Kit BK, Flegal KM. Trends in Obesity Prevalence Among Children and Adolescents in the United States, 1988-1994 Through 2013-2014. JAMA. 2016 Jun 7;315(21):2292-9. doi: 10.1001/jama.2016.6361.
PubMed 27272581Kamath CC, Vickers KS, Ehrlich A, McGovern L, Johnson J, Singhal V, Paulo R, Hettinger A, Erwin PJ, Montori VM. Clinical review: behavioral interventions to prevent childhood obesity: a systematic review and metaanalyses of randomized trials. J Clin Endocrinol Metab. 2008 Dec;93(12):4606-15. doi: 10.1210/jc.2006-2411. Epub 2008 Sep 9.
PubMed 18782880Loveman E, Al-Khudairy L, Johnson RE, Robertson W, Colquitt JL, Mead EL, Ells LJ, Metzendorf MI, Rees K. Parent-only interventions for childhood overweight or obesity in children aged 5 to 11 years. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD012008. doi: 10.1002/14651858.CD012008.
PubMed 26690844Boutelle KN, Cafri G, Crow SJ. Parent predictors of child weight change in family based behavioral obesity treatment. Obesity (Silver Spring). 2012 Jul;20(7):1539-43. doi: 10.1038/oby.2012.48. Epub 2012 Feb 23.
PubMed 22421896Brown CL, Skelton JA. Opportunities and Cautions in the Use of Commercially Delivered Weight-Management Programs for Children and Adolescents. J Pediatr. 2017 Jun;185:12-14. doi: 10.1016/j.jpeds.2017.02.068. Epub 2017 Mar 15. No abstract available.
PubMed 28318528Skelton 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.
PubMed 20880126Irby MB, Boles KA, Jordan C, Skelton JA. TeleFIT: adapting a multidisciplinary, tertiary-care pediatric obesity clinic to rural populations. Telemed J E Health. 2012 Apr;18(3):247-9. doi: 10.1089/tmj.2011.0117. Epub 2012 Feb 22.
PubMed 22356527Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
PubMed 18055651Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. No abstract available.
PubMed 26098405Abildso CG, Zizzi S, Fitzpatrick SJ. Predictors of clinically significant weight loss and participant retention in an insurance-sponsored community-based weight management program. Health Promot Pract. 2013 Jul;14(4):580-8. doi: 10.1177/1524839912462393. Epub 2012 Oct 17.
PubMed 23075503Devakumar D, Grijalva-Eternod C, Cortina-Borja M, Williams J, Fewtrell M, Wells J. Disentangling the associations between parental BMI and offspring body composition using the four-component model. Am J Hum Biol. 2016 Jul;28(4):524-33. doi: 10.1002/ajhb.22825. Epub 2016 Feb 5.
PubMed 26848813Naess M, Holmen TL, Langaas M, Bjorngaard JH, Kvaloy K. Intergenerational Transmission of Overweight and Obesity from Parents to Their Adolescent Offspring - The HUNT Study. PLoS One. 2016 Nov 16;11(11):e0166585. doi: 10.1371/journal.pone.0166585. eCollection 2016.
PubMed 27851798Turner-McGrievy GM, Wright JA, Migneault JP, Quintiliani L, Friedman RH. The interaction between dietary and life goals: using goal systems theory to explore healthy diet and life goals. Health Psychol Behav Med. 2014 Jan 1;2(1):759-769. doi: 10.1080/21642850.2014.927737. Epub 2014 Jul 15.
PubMed 25750817
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness/Feasibility of A Coordinated Parent/Child Dyad Weight Loss Intervention:
- ClinicalTrials.gov ID
- NCT04036331
- Acronym / sponsor ID
- IRB00059569
- Conditions
- Weight Loss, Pediatric Obesity, Overweight Adolescents, Parent-Child Relations, Family and Household
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescent Participants | Active comparator | Behavioral: Brenner FIT StandardBrenner 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. |
| Caregivers of Adolescent Participants | Experimental | Behavioral: By Design EssentialsWeight 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. |
| Co-enrollment | Experimental | Behavioral: Dyad PlusThis 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. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- BMI < 30
- Contraindication for physical activity or caloric restriction
- Cannot read or write English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brenner FIT StandardAfter 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. | Behavioural | Adolescent Participants |
| By Design EssentialsA 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). | Behavioural | Caregivers of Adolescent Participants |
| Dyad PlusThis 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. | Behavioural | Co-enrollment |
Primary outcome
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.
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.
Feasibility and Acceptability of Implementation
Time frame: Month 6
We will examine screening, recruitment, retention, adherence, and overall perception of Brenner FIT and By Design components
20 secondary outcomes
Physical Activity Assessment Tool (PAAT)-Adult
Time frame: Baseline
Physical Activity Assessment Tool (PAAT)-Adult
Time frame: 6 Months
Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)
Time frame: Baseline
Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)
Time frame: 6 months
Physical Activity Assessed Using Fitbit (Youth)
Time frame: Baseline
Physical Activity Assessed Using Fitbit (Youth)
Time frame: 6 Months
Concentration of fasting glucose for all participants, mg/dL
Time frame: Baseline
Concentration of fasting glucose for all participants, mg/dL
Time frame: 6 months
Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
Time frame: Baseline
Concentration of fasting Insulin for all participants, mg/dL
Time frame: Baseline
Concentration of fasting Insulin for all participants, mg/dL
Time frame: 6 months
Hemoglobin A1c concentration for all participants, measured in percentage
Time frame: Baseline
Hemoglobin A1c concentration for all participants, measured in percentage
Time frame: 6 months
Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)
Time frame: 6 months
Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
Time frame: Baseline
Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
Time frame: 6 months
Concentration of total cholesterol (mg/dL)
Time frame: Baseline
Concentration of total cholesterol (mg/dL)
Time frame: 6 months
Economic costs of the three intervention arms over duration of program (USD)
Time frame: Month 6
Diet for Parent and Youth
Time frame: Baseline and 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 18607383Kelly T, Yang W, Chen CS, Reynolds K, He J. Global burden of obesity in 2005 and projections to 2030. Int J Obes (Lond). 2008 Sep;32(9):1431-7. doi: 10.1038/ijo.2008.102. Epub 2008 Jul 8.
- Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Background: PubMed 27272581Ogden CL, Carroll MD, Lawman HG, Fryar CD, Kruszon-Moran D, Kit BK, Flegal KM. Trends in Obesity Prevalence Among Children and Adolescents in the United States, 1988-1994 Through 2013-2014. JAMA. 2016 Jun 7;315(21):2292-9. doi: 10.1001/jama.2016.6361.
- Background: PubMed 18782880Kamath CC, Vickers KS, Ehrlich A, McGovern L, Johnson J, Singhal V, Paulo R, Hettinger A, Erwin PJ, Montori VM. Clinical review: behavioral interventions to prevent childhood obesity: a systematic review and metaanalyses of randomized trials. J Clin Endocrinol Metab. 2008 Dec;93(12):4606-15. doi: 10.1210/jc.2006-2411. Epub 2008 Sep 9.
- Background: PubMed 26690844Loveman E, Al-Khudairy L, Johnson RE, Robertson W, Colquitt JL, Mead EL, Ells LJ, Metzendorf MI, Rees K. Parent-only interventions for childhood overweight or obesity in children aged 5 to 11 years. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD012008. doi: 10.1002/14651858.CD012008.
- Background: PubMed 22421896Boutelle KN, Cafri G, Crow SJ. Parent predictors of child weight change in family based behavioral obesity treatment. Obesity (Silver Spring). 2012 Jul;20(7):1539-43. doi: 10.1038/oby.2012.48. Epub 2012 Feb 23.
- Background: PubMed 28318528Brown CL, Skelton JA. Opportunities and Cautions in the Use of Commercially Delivered Weight-Management Programs for Children and Adolescents. J Pediatr. 2017 Jun;185:12-14. doi: 10.1016/j.jpeds.2017.02.068. Epub 2017 Mar 15. No abstract available.
- Background: PubMed 20880126Skelton 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.
- Background: PubMed 22356527Irby MB, Boles KA, Jordan C, Skelton JA. TeleFIT: adapting a multidisciplinary, tertiary-care pediatric obesity clinic to rural populations. Telemed J E Health. 2012 Apr;18(3):247-9. doi: 10.1089/tmj.2011.0117. Epub 2012 Feb 22.
- Background: PubMed 18055651Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
- Background: PubMed 26098405Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. No abstract available.
- Background: PubMed 23075503Abildso CG, Zizzi S, Fitzpatrick SJ. Predictors of clinically significant weight loss and participant retention in an insurance-sponsored community-based weight management program. Health Promot Pract. 2013 Jul;14(4):580-8. doi: 10.1177/1524839912462393. Epub 2012 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Moore principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brenner FIT Standard, By Design Essentials and Dyad Plus in people with Weight Loss and Pediatric Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04036331, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.