Clinical trial NCT03329300: Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life
Official title: Using Executive Function to Predict Outcomes and Adherence in Family-based Behavioral Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Executive Function
Keywords: Pediatric Obesity
Executive Function
Behavioral Intervention
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Nutrition Obesity Research Center
First posted: 2017-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We plan to examine whether child and parental cognitive/executive function predict body composition outcomes and adherence to a 6-month protocol of Family-Based Behavioral Treatment (FBT), for pediatric obesity. Our objectives are to: (1) examine the effects of parent and child complex cognitive functions on treatment outcomes and adherence in a 6-month FBT program for obesity in a diverse group of children aged 8-12 (total of 16 child-parent pairs), and (2) examine the strength of the relationship between parent and child cognitive function. We hypothesize that children with poorer executive function, and those who have parents with poorer executive function, will have poorer body composition and adherence outcomes.

Detailed description: Baseline assessments will include child and parent demographic data, medical history, and cognitive functioning, along with anthropometric measures such as height, weight, and body composition. Those who complete baseline assessments will be enrolled in one of two groups of family-based treatment on after-school evenings (8 pairs in each group; total of 16 child-caregiver pairs). A total of 24 weekly treatment sessions lasting up to 90 minutes each will be held over 6 months. Family-based behavioral treatment is a manualized, group intervention for children with obesity and their caregivers that incorporate participant-driven goal-based changes in diet and physical activity, and a variety of interactive educational session topics and behavioral support for reaching goals. A private weigh-in for children and caregivers will be conducted at each session. Sessions will begin with check-in with each family about weekly goal progress, after which the caregivers and children will split into separate groups for session-specific content including educational material tailored to nutrition, eating, and activity. The final portion of group session will involve children and caregivers merging in one group to share learning experiences and engage in collaborative goal-setting for the upcoming week(s). After the six month family-based behavioral intervention, baseline measures will be reassessed as well as overall program adherence. Program adherence will be evaluated using weekly program attendance and the number of days dietary/physical activity self-monitoring logs were completed.

Eligibility criteria: Inclusion Criteria:

1. Have a BMI ≥ 85th percentile
2. Are ≥8 and ≤12 years old at the beginning of treatment
3. Can read, write, and speak English, along with their parent
4. Plan to stay living within the local area during the study period
5. Have a consenting parent who can commit to all study procedures and provide reliable travel.

   * Siblings will be eligible for study inclusion if they meet the above criteria and will be allowed to use the same participating parent (sibling effects would then be addressed in statistical analyses).

Exclusion Criteria:

1. Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight
2. Are currently participating in a formal weight management program beyond their usual medical care or have a parent participating in a formal weight management program
3. Have been diagnosed with an intellectual disability or traumatic brain injury
4. Have medical contraindications to physical activity.

Primary outcomes:
measure: Change From Baseline Child Body Fat Mass at 6 Months
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Adherence to Treatment (Number of Contact Hours)
timeFrame: Baseline to 6 months
measure: Adherence to Treatment (Completed Days of Self-monitoring)
timeFrame: Baseline to 6 months
Other outcomes:
measure: Child Height
timeFrame: Baseline and 6 months
measure: Child Weight
timeFrame: Baseline and 6 months
measure: Change in Child Body Mass Index
timeFrame: Baseline to 6 months
measure: Parent/Guardian Height
timeFrame: Baseline and 6 months
measure: Parent/Guardian Weight
timeFrame: Baseline and 6 months
measure: Change in Parent/Guardian Body Mass Index
timeFrame: Baseline to 6 months
measure: Change in Executive Functioning - Inhibitory Control
timeFrame: Baseline and 6 months
measure: Change in Executive Functioning - Working Memory
timeFrame: Baseline and 6 months
measure: Change in Executive Functioning - Cognitive Flexibility
timeFrame: Baseline to 6 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham Department of Pediatrics
name: Marissa Gowey, PhD
role: PRINCIPAL_INVESTIGATOR
References: