Clinical trial NCT02677792: Wellness and Weight Family Group Project
Official title: Wellness and Weight Family Group Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.


Eligibility criteria: Inclusion Criteria:

1. child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit
2. child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender)
3. child or adolescent is accompanied by a parent or legal guardian
4. participating child and parent speak and read English
5. family agrees to attend group meetings at a medical clinic over a 3 month period

Exclusion Criteria:

1. participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma)
2. child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)
3. child or parent, according to parent report, in commercial weight loss program
4. child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report
5. parent and child do not speak and read English

Primary outcomes:
measure: Change in Child Weight Status (BMIz)
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary outcomes:
measure: Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Child Dietary Intake Total kcals from 24-hour dietary recall
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Child A1C Values
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Child Glucose Values
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Parent Weight
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Parent Dietary Intake Total kcals from 24-hour dietary recall
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Other outcomes:
measure: Change in Child Self-Efficacy for Total Healthy Lifestyle Behaviors
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Child-Reported Total Health-Related Quality of Life
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Parent-Reported Total Health-Related Quality of Life
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Child Psychological Functioning (Total Problems Subscale from CBCL)
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Home Food Inventory Obesiogenic Food Availability Score
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
measure: Change in Total Parenting Competence
timeFrame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Crystal S. Lim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: