Family, Responsibility, Education, Support, and Health for Food Responsiveness

Официальное название

Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat

Обзор

The objective of this proposed study is to compare Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education and reducing energy intake (ROC+) and a health education comparator (HE) for children with overweight or obesity who are high on food responsiveness (FR).

Подробное описание

The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that FBT has merit for some children, but not all, this study will compare ROC to FBT, ROC with nutrition education and reducing energy intake (ROC+), and Health Education (HE). Treatment will consist of weekly individual sessions for the first 16 sessions, then twice per month for the final 2 months for a total of 20 sessions. The investigators will recruit children ages 7-12 with overweight or obesity who are high in food responsiveness (FR) and their parent and will conduct assessments at baseline, post-treatment (month 6), 6-month follow-up (month 12) and 12-month follow-up (month 18).

Вмешательства

• Поведенческое Regulation of Cues
  ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to improve satiety responsiveness and decrease food cue responsiveness. This arm will include an experiential component, including hunger monitoring during a meal or snack and participating in exposure exercises.
• Поведенческое Family Based Behavioral Treatment
  FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
• Поведенческое Regulation of Cues +
  ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
• Поведенческое Health Education
  The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Первичные конечные точки

• Child age and sex adjusted body mass index z-score (BMIz) [Срок оценки: Change from baseline at 3 months, 6 months, 12 months, and 18 months]
• Child percentage of the 95th percentile BMI (%BMIp95) [Срок оценки: Change from baseline 3 months, 6 months, 12 months, and 18 months]
• Change in Child Overeating [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]

Вторичные конечные точки (12)

• Child Food Cue Responsiveness as measured by the Child Eating Behavior Questionnaire [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]]
• Child Food Cue Responsiveness as measured during exposure to a preferred food [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]
• Child Satiety Responsiveness as measured by the Child Eating Behavior Questionnaire [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]
• Child Satiety Responsiveness as measured by the Water Load Task (WLT) [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]
• Child Inhibition as measured by the Stop Signal Task [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]
• Child Inhibition as measured by the Go No Go (GNG) Task [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]
• Child Energy Intake [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]
• Parent Body Mass Index (BMI) [Срок оценки: Change from baseline at 3 months, 6 months,12 months, and 18 months]
• Parent Overeating [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]
• Parent Food Cue Responsiveness as measured by the Adult Eating Behavior Questionnaire [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]
• Parent Food Cue Responsiveness as measured during exposure to a preferred food [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]]
• Parent Satiety Responsiveness as measured by the Adult Eating Behavior Questionnaire [Срок оценки: Change from baseline at 6 months,12 months, and 18 months]

Критерии участия

Критерии включения

• Informed assent and parental consent
• A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age
• Child high on FR - High FR will be measured by the Food Responsiveness Scale via the CEBQ, with scores at a 3.8 or higher constituting a child with high FR.
• A parent responsible for food preparation who is willing to participate and can read, speak and understand English at a minimum of a 5th grade level
• Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments
• Child is on stable medication regimen for medications that can impact weight (3+ months)
• Child does not have medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity with their child or provide opportunities for the child to complete recommended physical activity

Критерии исключения

• Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
• Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and exercise prescription may be warranted
• Child who is taking medication for weight loss
• Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
• First degree relative or someone in the household with anorexia or bulimia nervosa.

Potential participants with medical or psychological diagnosis that could make adherence with the study protocol difficult or dangerous will not be included.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• UC San Diego Center for Healthy Eating and Activity Research (CHEAR) — La Jolla
• Ambulatory Research Center - University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT06207110 · 806055 · 1R01DK135599

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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