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Wellness and Weight Family Group Project

Wellness and Weight Family Group Project

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02677792
Enrollment
34
Registered
2016-02-09
Start date
2016-02-29
Completion date
2022-12-31
Last updated
2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

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.

Interventions

BEHAVIORALBehavioral Family Intervention (BFI)

Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact).

Sponsors

University of Mississippi Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Child Weight Status (BMIz)Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)BMIz calculated from measured child height and weight

Secondary

MeasureTime frameDescription
Change in Child Dietary Intake Total kcals from 24-hour dietary recallBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Child-report 24-hour dietary recall assessed via Automated Self-administered 24-hour recall (ASA24) System; Children will complete the ASA-2014-Kids
Change in Total Child Physical Activity kcals from Block Kids Physical Activity ScreenerBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Child-report questionnaire
Change in Child A1C ValuesBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)From child medical chart - testing completed as part of standard medical care
Change in Child Glucose ValuesBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)From child medical chart - testing completed as part of standard medical care
Change in Parent WeightBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Measured parent weight
Change in Total Parent Physical Activity kcals from Block Physical Activity Screener AdultsBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Parent-report questionnaire
Change in Parent Dietary Intake Total kcals from 24-hour dietary recallBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Parent-report 24-hour dietary recall assessed via ASA24-2014

Other

MeasureTime frameDescription
Change in Parent-Reported Total Health-Related Quality of LifeBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Parent-report; total score from Pediatric Quality of Life Inventory
Change in Child Psychological Functioning (Total Problems Subscale from CBCL)Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)parent-report; Child Behavior Checklist (CBCL) Total Problems Scale
Change in Home Food Inventory Obesiogenic Food Availability ScoreBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Parent-reported
Change in Total Parenting CompetenceBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Parent-report; Total score from Parenting Sense of Competency (PSOC) Scale
Change in Child-Reported Total Health-Related Quality of LifeBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Child-report; total score from Pediatric Quality of Life Inventory
Change in Child Self-Efficacy for Total Healthy Lifestyle BehaviorsBaseline, Post-Treatment (Month 3), and Follow-up (Month 5)Child-report questionnaire; sum of scores from Child Dietary Self-Efficacy Scale and Self-Efficacy for Physical Activity Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026