Primary Care Pediatrics Learning Activity and Nutrition With Families

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.

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 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.