Wellness and Weight Family Group Project

NCT ID: NCT02677792

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2022-12-31

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.

Conditions

Pediatric Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Family Intervention (BFI)

Group Type: EXPERIMENTAL

Behavioral Family Intervention (BFI)

Intervention Type: BEHAVIORAL

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).

Interventions

Behavioral 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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Crystal Stack Lim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Crystal S. Lim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

#2015-0155

Identifier Type: -

Identifier Source: org_study_id