Evaluating Hunger Manipulation as an Adjunct to Behavioral Intervention During Intensive Multidisciplinary Feeding Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Percentage of oral intake
研究概览
简要总结
The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used in an intensive multidisciplinary feeding intervention (IMFI) model of treatment (standard care), for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.
详细描述
The recognized standard of care for children dependent on feeding tubes is intensive multidisciplinary feeding intervention (IMFI) involving a professional team that includes psychologists, physicians, nurse practitioners, registered dietitian nutritionists, and speech-language pathologists/occupational therapists working together in inpatient or day hospital settings. A meta-analysis of 11 studies involving intensive, multidisciplinary intervention reported that 71% (95% CI, 54%-83%) of 454 patients successfully weaned from feeding tube dependence at discharge from inpatient or intensive day treatment programs. Treatment gains were maintained following discharge, with 80% (95% CI, 66%-89%) of 414 patients successfully weaned from tube feedings at last follow-up. The most common treatment approaches documented by the meta-analysis involved behavioral intervention and tube weaning (hunger manipulation - evoking a state of hunger to encourage oral consumption by rapidly weaning from the tube). The review highlighted the lack of consensus among clinicians and researchers regarding the criteria for, rate of, and timing of weaning from enteral feedings.
As a result, the authors concluded that the relative contribution of aggressive tube weaning as a standalone or adjunctive therapy to behavioral intervention remains uncertain.
The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used as an adjunct to our standard model of behavioral intervention within the study team's IMFI program, for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.
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 (Investigator)
盲法说明
The allocation pattern is concealed to the investigators and therapists providing intervention.
入排标准
- 年龄范围
- 18 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between the ages of 18 months and 6 years of age;
- •Present with dependence on enteral feeding for at least 80% of their daily caloric needs; - Have some prior experience consuming food orally;
- •Demonstrate safe and functional swallowing;
- •Present without neuromuscular conditions who are non-ambulatory (such as cerebral palsy);
- •Have a body mass index in the 15th percentile, or greater;
- •Present with no evidence of moderate or severe malnutrition (weight for age or BMI of age z-score < -1) or recent weight loss;
- •Engage in no severe problem behavior outside of mealtimes;
- •Have a stable sleep schedule that will not interfere with therapeutic meals throughout the day;
- •Caregivers must be English-speaking;
- •Caregivers must be present for and participate in all treatment sessions.
排除标准
- •Individuals with significant active medical conditions requiring oversight from a physician;
- •Subjects who display severe problematic behaviors outside of the mealtime, necessitating intervention to specifically address those behaviors; -
- •Subjects with medical, structural, or functional limitations preventing safe oral intake of pureed foods;
- •Subjects with documented evidence of moderate to severe malnutrition or recent weight loss;
- •Individuals with avoidance/restrictive food intake disorders who are not dependent on enteral feedings for at least 80% of their daily caloric needs.
研究组 & 干预措施
Intensive Multidisciplinary Intervention (Standard Care)
Children with a history of chronic food refusal will be randomized to receive the standard of care. The standard of care for tube wean is to accomplish the balance between enteral supplementation and oral intake, the tube feeding regimen will follow the schedule of therapeutic meals (e.g., mid-day supplementation occurs after morning therapeutic meals).
干预措施: Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care (Behavioral)
Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean)
Children with a history of chronic food refusal will be randomized to receive the experimental arm that combines standard care with rapid tube wean.
All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use regular tube wean sheet to provide credit for oral intake for remainder of admission.
干预措施: Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning (Behavioral)
结局指标
主要结局
Change in Percentage of oral intake
时间窗: Up to 12 months
The percent oral intake will be calculated by dividing calories consumed during therapeutic meals by the daily calorie target.
Percent of patients achieving full wean and time to full wean
时间窗: Measured in days with a time frame of up to 12 months
% of participants reaching 100% of their caloric needs by mouth
次要结局
- Mealtime performance.(Up to 12 months)
- Change in weight and BMI(Up to 12 months)
研究者
Valerie M. Volkert
Associate Professor
Emory University