Pediatric Obesity
Conditions
Keywords
Childhood weight control
Brief summary
This study is designed to translate an evidence-based family-based weight loss treatment for childhood obesity (FBT) into primary care settings using co-located interventionists to serve as a model for care delivered within a patient-centered medical home. FBT will be compared to usual care (UC), and the families will be followed for a 2 year period to assess between group differences in the targeted child and parent outcomes, weight changes in non-targeted siblings who are overweight/obese, parent and child changes in delay of gratification, and how these changes relate to weight loss, and the assessment of how provider attitudes predict their intention to use FBT in the future. The results of this study will inform future dissemination and implementation of FBT into primary care settings.
Detailed description
Family-based treatment (FBT) is a behavioral weight control intervention that targets children who have overweight/obesity and their parents, and has the capacity to improve the weight status of non-targeted family members such as siblings. FBT has significant positive effects on body weight in children for up to 10-years of follow-up, and a robust relationship is observed between child and parent outcomes. FBT's concurrent care of two generations of obesity in the family is more efficacious and cost-effective than if family members are treated by their separate health care providers. Despite its recognized efficacy, FBT is mainly available in specialty clinics and many children fail to receive this guideline-based level of treatment, as recommended by the U.S. Preventive Services Task Force. Primary care offers an optimal setting for delivery of FBT by capitalizing on the established relationship between primary care providers and families. Using interventionists co-located within the primary care setting overcomes barriers posed by fragmentation of care, and lack of provider time and training. One of the challenges to integrating childhood obesity treatment into primary care is optimizing limited health care resources. In behavioral weight loss programs, some individuals learn diet, physical activity, and behavior change information quickly, while others learn more slowly. Individuals also differ in their ability to implement treatment recommendations due to individual differences, such as problems with delaying gratification. FBT accommodates these individual differences by using a personalized system of instruction, or a mastery model, in which the content and dose of treatment is calibrated to the needs of the family, ensuring that treatment effort is consistent with need. This multi-site, clinical trial aims to evaluate over a two year period the effectiveness of FBT delivered by a trained interventionist co-located within primary care plus usual care delivered by the primary care provider (FBT) compared to usual care (UC). Participants will be a representative sample of 528 families with a 6-12 year-old child and a parent who have both overweight/obesity. Weight changes in approximately 228 siblings who have overweight/obesity and between 2-18 years of age will also be studied. This study will test between group differences in child (Primary Specific Aim 1A) and parent (Secondary Specific Aim 1) weight change, as well as weight change in siblings who have overweight/obesity (Secondary Aim 2), changes in parent and child delay of gratification, and how changes in delay of gratification are related to parent and child weight changes (Secondary Aim 3), participant level predictors of treatment success (Secondary Aim 4), and how provider attitudes toward evidence-based treatment and perceptions of FBT may relate to their intention to use colocated FBT in their practices in the future (Exploratory Aim 1). Establishing that FBT can be effectively implemented within real world settings is crucial to creating a system by which children and their families who suffer from obesity can be treated in a centralized primary care setting.
Interventions
BEHAVIORALFamily-based treatment
Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
BEHAVIORALUsual Care
Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Assessor will be blinded to the families group assignment. Coaches will be back up assessor. Coach 1 will be an assessor for families assigned to Coach 2, Coach 2 will collect measures for families assigned to Coach 3, and Coach 3 will collect measures for families assigned to Coach 1. Thus, coaches will not collect height and weight measures for families from their caseload. Although not possible to guarantee that coaches are blind to condition for families that are not in their caseload due to the families not being blinded, use of a standard protocol (see Appendix C) ensures objective and reliable measurement of the primary outcome. Assessors will be blind to prior heights/weights, further protecting against assessment bias.
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The participating child will be between the ages of 6 and 12 and have a BMI above the 85th percentile for age and sex. The participating child will have at least one parent who has overweight or obesity (BMI\>25) and who must agree to attend all parent/child treatment meetings as the participating parent. For families in which one parent has overweight/obesity, this parent will be required to be the participating parent in order for the family to be eligible for the study; if two parents have overweight/obesity, the family will choose one parent to enroll in the study. Similarly, if two children in the family have overweight/obesity, it will be encouraged that the older sibling be the primary participant, as it is more likely the younger sibling will model the older sibling. Though only the child who has overweight/obesity and the participating parent will be required to attend treatment sessions, all family members living in the household, including other adults and siblings, will be encouraged to participate indirectly by supporting changes in the family's lifestyle. Because a secondary aim of the study involves the tracking of treatment effects through the household to non-targeted siblings, heights and weights of at least one sibling with overweight/obesity (BMI\>85th percentile for age and sex)in the family will be collected, if applicable. Only siblings ages 2- 18 would qualify. All participants must be able to speak and comprehend English at a first-grade level.
Exclusion criteria
The participating parent or child will not have had a concussion in the past three months; will not have any significant developmental delays or intellectual disabilities; will not be receiving treatment for a Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) disorder that interferes with treatment delivered as part of the intervention; will not have a physical disability or diagnosis that prevents performance of physical activity at a level equivalent to a brisk walk or that places severe restriction on diet; will not be on a medication regimen that affects weight; will not have a medical condition that alters nutritional status, intestinal absorption, or affects weight; will not have undergone weight loss surgery; and will not be participating in an alternate weight control program. Families in which either the participating child or parent is actively involved in other weight-loss treatment, is using weight-affecting medications, or has an impairing psychiatric or medical condition that would hinder participation in the study will be excluded as identified by the screening assessments. Families that are planning to move or in which the participating parent is pregnant or is planning on becoming pregnant during the 2 year study period will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition Measures of Targeted Child. Percent Change Over the Median BMI | 0 - 24 months | Height and weight will be taken to calculate changes in over weight status for children in FBT versus UC. Change in percent over median BMI from baseline to 24-month. Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents. Results are pooled across 10 multiple imputations and reported as mean (standard error) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month | 0-24 months | Height and weight will be taken to calculate changes in over weight status for parents in FBT versus UC. Results are pooled across 10 multiple imputations and reported as mean (standard error) |
| Body Composition Measures, Siblings | 0-24 months | Height and weight will be taken for non-targeted siblings to determine if weight loss effects of FBT extend beyond the participating parent and child. |
| Delay Discounting | 0, and 24 months | Delay discounting will be measured using an adjusting amount discounting task with a delayed reward of $100. K-values will be calculated and log-versions will be used due to skewness of k-values. More negative k-values indicate more delayed choices, which is considered better decision making |
Countries
United States
Participant flow
Recruitment details
Each sites local pediatric practices participated in warm hand offs to embeded coaches in the practices to recruit interested families. Families included a targeted child, targeted parent and could include one or multiple siblings but was not required. Recruitment started in November 2017 through August 2019.
Pre-assignment details
Eligible families were randomized through REDCap directly after completing the screening visit before starting the treatment phase.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (UC) Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff. | 504 |
| Family-based Treatment (FBT) Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two yeart study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff. | 506 |
| Total | 1,010 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 84 | 94 |
| Overall Study | Withdrawal by Subject | 7 | 26 |
Baseline characteristics
| Characteristic | Usual Care (UC) | Family-based Treatment (FBT) | Total |
|---|---|---|---|
| Age, Continuous Index children | 9.7 years STANDARD_DEVIATION 1.9 | 9.8 years STANDARD_DEVIATION 1.9 | 9.7 years STANDARD_DEVIATION 1.9 |
| Age, Continuous Parents | 41.4 years STANDARD_DEVIATION 7 | 41.2 years STANDARD_DEVIATION 7.8 | 41.3 years STANDARD_DEVIATION 7.5 |
| Age, Continuous Siblings | 10.4 years STANDARD_DEVIATION 3.8 | 9.7 years STANDARD_DEVIATION 3.6 | 10.0 years STANDARD_DEVIATION 3.7 |
| Body mass index (BMI) Parents | 37.5 kg/m^2 STANDARD_DEVIATION 7.9 | 36.5 kg/m^2 STANDARD_DEVIATION 7.6 | 37.0 kg/m^2 STANDARD_DEVIATION 7.8 |
| Body mass index (BMI) Siblings | 27.4 kg/m^2 STANDARD_DEVIATION 7.9 | 24.4 kg/m^2 STANDARD_DEVIATION 5.6 | 25.9 kg/m^2 STANDARD_DEVIATION 7 |
| Body mass index (BMI) Targeted Children | 26.9 kg/m^2 STANDARD_DEVIATION 5.2 | 26.7 kg/m^2 STANDARD_DEVIATION 5 | 26.8 kg/m^2 STANDARD_DEVIATION 5.1 |
| Child BMI percentile Siblings | 98.04 percentile | 96.96 percentile | 97.43 percentile |
| Child BMI percentile Targeted Children | 98.46 percentile | 98.27 percentile | 98.40 percentile |
| Child percent over median body mass index Sibling | 51.8 percent | 37.3 percent | 41.9 percent |
| Child percent over median body mass index Targeted Children | 53.8 percent | 56.1 percent | 54.7 percent |
| Ethnicity (NIH/OMB) Parents Hispanic or Latino | 8 Participants | 17 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Parents Not Hispanic or Latino | 218 Participants | 209 Participants | 427 Participants |
| Ethnicity (NIH/OMB) Parents Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Siblings Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Siblings Not Hispanic or Latino | 47 Participants | 48 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Siblings Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Targeted Children Hispanic or Latino | 19 Participants | 21 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Targeted Children Not Hispanic or Latino | 207 Participants | 205 Participants | 412 Participants |
| Ethnicity (NIH/OMB) Targeted Children Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Participants Parents | 226 Participants | 226 Participants | 452 Participants |
| Participants Siblings | 52 Participants | 54 Participants | 106 Participants |
| Participants Targeted children | 226 Participants | 226 Participants | 452 Participants |
| Race (NIH/OMB) Parents American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Parents Black or African American | 55 Participants | 58 Participants | 113 Participants |
| Race (NIH/OMB) Parents More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Parents Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents Unknown or Not Reported | 27 Participants | 16 Participants | 43 Participants |
| Race (NIH/OMB) Parents White | 139 Participants | 148 Participants | 287 Participants |
| Race (NIH/OMB) Siblings American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Siblings Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Siblings Black or African American | 13 Participants | 12 Participants | 25 Participants |
| Race (NIH/OMB) Siblings More than one race | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Siblings Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Siblings Unknown or Not Reported | 12 Participants | 9 Participants | 21 Participants |
| Race (NIH/OMB) Siblings White | 21 Participants | 27 Participants | 48 Participants |
| Race (NIH/OMB) Targeted Children American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Targeted Children Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Targeted Children Black or African American | 65 Participants | 58 Participants | 123 Participants |
| Race (NIH/OMB) Targeted Children More than one race | 22 Participants | 17 Participants | 39 Participants |
| Race (NIH/OMB) Targeted Children Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Targeted Children Unknown or Not Reported | 8 Participants | 15 Participants | 23 Participants |
| Race (NIH/OMB) Targeted Children White | 127 Participants | 131 Participants | 258 Participants |
| Sex: Female, Male Parents Female | 192 Participants | 196 Participants | 388 Participants |
| Sex: Female, Male Parents Male | 34 Participants | 30 Participants | 64 Participants |
| Sex: Female, Male Siblings Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Siblings Male | 22 Participants | 24 Participants | 46 Participants |
| Sex: Female, Male Targeted Children Female | 122 Participants | 120 Participants | 242 Participants |
| Sex: Female, Male Targeted Children Male | 104 Participants | 106 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 504 | 0 / 506 |
| other Total, other adverse events | 314 / 504 | 345 / 506 |
| serious Total, serious adverse events | 24 / 504 | 39 / 506 |
Outcome results
Primary
Body Composition Measures of Targeted Child. Percent Change Over the Median BMI
Height and weight will be taken to calculate changes in over weight status for children in FBT versus UC. Change in percent over median BMI from baseline to 24-month. Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents. Results are pooled across 10 multiple imputations and reported as mean (standard error)
Time frame: 0 - 24 months
Population: Targeted Children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Body Composition Measures of Targeted Child. Percent Change Over the Median BMI | 10.2 percent change | Standard Deviation 1 |
| Family-based Treatment (FBT) | Body Composition Measures of Targeted Child. Percent Change Over the Median BMI | 3.4 percent change | Standard Deviation 1.3 |
p-value: <0.0595% CI: [-10.14, -2.29]ANCOVA
Secondary
Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month
Height and weight will be taken to calculate changes in over weight status for parents in FBT versus UC. Results are pooled across 10 multiple imputations and reported as mean (standard error)
Time frame: 0-24 months
Population: Participating Parents
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month | -0.03 Change in kg/m^2 (BMI) | Standard Deviation 0.22 |
| Family-based Treatment (FBT) | Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month | -0.62 Change in kg/m^2 (BMI) | Standard Deviation 0.24 |
p-value: 0.00195% CI: [-5.68, -2.26]ANCOVA
Secondary
Body Composition Measures, Siblings
Height and weight will be taken for non-targeted siblings to determine if weight loss effects of FBT extend beyond the participating parent and child.
Time frame: 0-24 months
Population: Siblings
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Body Composition Measures, Siblings | 8.3 Change in % over median BMI | Standard Deviation 2.6 |
| Family-based Treatment (FBT) | Body Composition Measures, Siblings | 6.6 Change in % over median BMI | Standard Deviation 2.9 |
Secondary
Delay Discounting
Delay discounting will be measured using an adjusting amount discounting task with a delayed reward of $100. K-values will be calculated and log-versions will be used due to skewness of k-values. More negative k-values indicate more delayed choices, which is considered better decision making
Time frame: 0, and 24 months
Population: Parents and children are reported separately. Intent to treat was not used, number analyzed included parents and children with complete data (baseline and 24 month delay discounting measures). Siblings are not analyzed here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UC) | Delay Discounting | Parent baseline delay discounting log k-value | -5.98 natural log | Standard Deviation 3.21 |
| Usual Care (UC) | Delay Discounting | Parent 24-month Delay discounting log k-value | -6.45 natural log | Standard Deviation 2.58 |
| Usual Care (UC) | Delay Discounting | Child baseline delay discounting log k-value | -4.37 natural log | Standard Deviation 4.02 |
| Usual Care (UC) | Delay Discounting | Child 24-month Delay discounting log k-value | -4.76 natural log | Standard Deviation 3.23 |
| Family-based Treatment (FBT) | Delay Discounting | Child 24-month Delay discounting log k-value | -4.71 natural log | Standard Deviation 2.62 |
| Family-based Treatment (FBT) | Delay Discounting | Parent baseline delay discounting log k-value | -6.14 natural log | Standard Deviation 2.54 |
| Family-based Treatment (FBT) | Delay Discounting | Child baseline delay discounting log k-value | -4.22 natural log | Standard Deviation 3.48 |
| Family-based Treatment (FBT) | Delay Discounting | Parent 24-month Delay discounting log k-value | -6.75 natural log | Standard Deviation 2.43 |
Comparison: repeated measures analysis of variance for parent delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.p-value: 0.65ANOVA
Comparison: repeated measures analysis of variance for child delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.p-value: 0.87ANOVA