Examining the Role of Executive Functioning in Family-Based Intensive Health Behavior and Lifestyle Treatment

Официальное название

Examining the Role of Executive Functioning in Family-Based Intensive Health Behavior and Lifestyle Treatment to Address Pediatric Obesity (Healthy LIFT Groups)

Обзор

The objectives of this open trial feasibility study are to examine the impacts of intensive health behavior and lifestyle treatment (IHBLT) on youth and caregiver executive functioning (EF), weight status, health behaviors (dietary intake, disordered eating, physical activity), and psychological functioning. Investigators propose to enroll 10 youth 13 to 17 years of age who have overweight or obesity (OV/OB) and a primary caregiver. Families will receive six months of evidence-based family focused group IHBLT based on social, cognitive, and family systems theories. Families will complete assessments of EF skills (objective and self-report), weight status, dietary intake, physical activity, and psychological functioning at pre- and post-treatment.

Вмешательства

• Поведенческое intensive health behavior and lifestyle treatment
  the IHLBT will consist of 18 group meetings over 6 months that teens and parents attend. Topics covered during the meetings will include discussions regarding nutrition and physical activity recommendations, family communication, and use of strategies like monitoring, planning, goal setting, and problem solving.

Первичные конечные точки

• Youth EF - CPT-3 Commissions [Срок оценки: Post-Treatment (Month 6)]
• Youth EF - Stroop [Срок оценки: Post-Treatment (Month 6)]
• Youth EF - Trails B [Срок оценки: Post-Treatment (Month 6)]
• Youth EF - BRIEF-2 Self Report GEC [Срок оценки: Post-Treatment (Month 6)]
• Youth EF - BRIEF-2 Parent Report GEC [Срок оценки: Post-Treatment (Month 6)]

Вторичные конечные точки (3)

• Youth Weight Status [Срок оценки: Post-Treatment (Month 6)]
• Youth Dietary Intake [Срок оценки: Post-Treatment (Month 6)]
• Youth Physical Activity [Срок оценки: Post-Treatment (Month 6)]

Критерии участия

Критерии включения

• Youth 13-17 years old
• Youth with OV/OB (BMI≥85th percentile for age/gender norms)
• Participating caregiver must be the participating youth's legal guardian
• Participating youth and caregiver speak and read English
• Participating youth and caregiver agree to attend IHBLT group meetings in-between the pre- and post-treatment assessments.

Критерии исключения

• Youth pervasive developmental disorder (e.g., intellectual disability)
• Youth or caregiver in commercial weight loss program or taking prescribed medications for the prior three months that impact appetite or weight
• Youth or caregiver with documented history of eating disorder or untreated severe depression
• Both youth and caregiver scores are two standard deviations or above the mean on the CPT-3 Commissions and Stroop Interference, representing significantly higher than average EF skills.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• College of Health Sciences, University of Missouri — Columbia

Идентификаторы

NCT: NCT06969235 · 2122709

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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