Weight LossNCT03811743
A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)
A study testing Brenner FIT, By Design and Coordination 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 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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Weight Loss, Pediatric Obesity
- What is being tested?
- Brenner FIT, By Design and Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2020to 16 Jun 2020
- 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
- Over the age of 65
- 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, 27157
About this study
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.
Read the detailed description
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.
- Conditions
- Weight Loss, Pediatric Obesity
- Being tested
- Brenner FIT, By Design, Coordination
- Keywords
- Youth, Parents, Overweight, Families
- Medical subject headings
- Weight Loss, Pediatric Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brenner FITBehavioural
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.
By DesignBehavioural
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.
CoordinationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Adolescents Participants | Experimental | 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 Receives: Behavioral: Brenner FIT; Behavioral: Coordination |
| Caregivers of adolescents participants | Experimental | 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 Receives: Behavioral: By Design; Behavioral: Coordination |
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: 3 Months
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
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Caloric intake expressed in kcals
Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
Measured: Baseline
Caloric intake expressed in kcals
Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.
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.
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.
Measured: 6 months
Concentration of fasting Insulin for all participants, mg/dL
Fasting insulin levels will be gathered from all participants.
Measured: Baseline
Concentration of fasting Insulin for all participants, mg/dL
Fasting insulin levels will be gathered from all participants.
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.
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.
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.
Measured: 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.
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.
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.
Measured: 6 months
Concentration of total cholesterol (mg/dL)
total cholesterol: less than 200 mg/dL
Measured: Baseline
Concentration of total cholesterol (mg/dL)
total cholesterol: less than 200 mg/dL
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.
Measured: Baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start25 Feb 2020
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Moore, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811743
- Sponsor's protocol ID
- IRB00055004
- Status last verified
- May 2021
- First submitted
- 10 Jan 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20880126
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)
- ClinicalTrials.gov ID
- NCT03811743
- Acronym / sponsor ID
- IRB00055004
- Conditions
- Weight Loss, Pediatric Obesity
- Keywords
- Youth, Parents, Overweight, Families
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 22 Jan 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents Participants | Experimental | Behavioral: Brenner FIT, Behavioral: CoordinationAdolescents 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 |
| Caregivers of adolescents participants | Experimental | Behavioral: By Design, Behavioral: CoordinationAdult 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 |
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 (4 listed)
- Over the age of 65
- 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 FITBrenner 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. | Behavioural | Adolescents Participants |
| By DesignWeight 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. | Behavioural | Caregivers of adolescents participants |
| CoordinationThis 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 | Behavioural | Adolescents Participants, Caregivers of adolescents participants |
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: 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.
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.
21 secondary outcomes
Physical Activity Assessed by Accelerometry
Time frame: Baseline
Physical Activity Assessed by Accelerometry
Time frame: 6 months
Physical Activity Assessed by PAQ-A
Time frame: Baseline
Physical Activity Assessed by PAQ-A
Time frame: 6 months
Physical Activity Assessed by IPAQ
Time frame: Baseline
Physical Activity Assessed by IPAQ
Time frame: 6 months
Caloric intake expressed in kcals
Time frame: Baseline
Caloric intake expressed in kcals
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
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: Baseline
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: Baseline through 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 22 Mar 2023.
- 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.
- Individual participant dataSharing planned: No
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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, PhD 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, By Design and Coordination 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 4 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 22 Mar 2023. 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 NCT03811743, which also lists 1 linked publication.
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 22 Mar 2023; AzTrials last refreshed its copy on 4 Nov 2026.