Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Child %BMIp95
研究概览
简要总结
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).
详细描述
The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A child with OW/OB (>=85% BMI for age) aged 6-12 years
- •Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
- •The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician
- •The parent who is responsible for food preparation is willing to participate
- •The family is willing to commit to attending all treatment and assessment sessions
- •Child on a stable regimen of prescription medications which affect appetite or weight (minimum of 3 months)
- •Child does not have any medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity.
- •Child and/or parent are not participating in another organized weight control program
- •Family owns a device that can facilitate zoom meetings
排除标准
- •Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed
- •Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
- •Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.
- •Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
- •Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration
- •Child is taking medication for the purpose of weight loss
研究组 & 干预措施
PBT-A
PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth.
干预措施: PBT-A (Behavioral)
Health Education
This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.
干预措施: Health Education (HE) (Behavioral)
结局指标
主要结局
Child %BMIp95
时间窗: Change from baseline to month 3, 6, 12, and 18
Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights
Child BMIz age and sex adjusted BMI (kg/m^2)
时间窗: Change from baseline to month 3, 6, 12, and 18
age and sex adjusted body mass index (BMI) z-score based on the CDC norms
次要结局
- Child Dietary Intake(Change from baseline to month 6, 12, and 18)
- Parent Dietary Intake(Change from baseline to month 6, 12, and 18)
- Parent Physical Activity(Change from baseline to month 6, 12, and 18)
- Child Physical Activity(Change from baseline to month 6, 12, and 18)
- Child Mealtime Behaviors(Change from baseline to month 6, 12, and 18)
- Parent self-efficacy(Change from baseline to month 6, 12, and 18)
- Parent body mass index (BMI)(Change from baseline to mid-treatment, months: 3, 6, 12, and 18)
- Parenting as measured by the Alabama Parenting Questionnaire (APQ)(Change from baseline to month 6, 12, and 18)
研究者
Kerri Boutelle
Kerri Boutelle, Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science
University of California, San Diego