A Mixed Methods, Single-group, Single-center Feasibility Study of a Food Response Training to Reduce Unhealthy Dietary Intake and Promote Weight Loss in Racially and Ethnically Diverse Patients With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Health Eating Index (HEI-2015) Score
研究概览
简要总结
The aim of this mixed methods, single-group, single-center study will be to examine the feasibility of a food response training (FRT). This study will be conducted in patients with obesity recruited from NYU Langone Health. Measurements will occur at screening, baseline, and 3 months, for a subgroup of participants for we will collect saliva samples for genetic analysis at baseline assessment (ancillary study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 to 80 years of age
- •BMI ≥30.0 kg/m2
- •access to a computer or an iPhone/iPad or be willing to use a study loaner smart phone
排除标准
- •pregnant or breastfeeding or plan to become pregnant in the next 6 months, or who become pregnant during the study
- •taking any medication that may impact dietary intake and weight:
- •a. Immunosuppressants, steroids, medications for weight loss or to manage blood sugars or a psychiatric condition other than anxiety/depression
- •enrolled in another intervention that could influence dietary intake
- •have had bariatric surgery within the past 2 years
- •unwilling to delay bariatric surgery for the next 6 months
- •who have gained or loss more than 5.5 kg in the previous 3 months
- •unable to participate meaningfully in an intervention that involves using software available in English. The reason for this is that the food training apps have not been designed or validated in audio form or in other languages. (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
- •institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet), unwilling or inability to provide informed consent.
结局指标
主要结局
Health Eating Index (HEI-2015) Score
时间窗: Week 12
HEI-2015 is a measure of diet quality used to assess how well a set of foods aligns with key recommendations of the Dietary Guidelines for Americans. The total HEI-2015 score for Americans is 59 out of 100; the higher the score, the more the foods align with key recommendations.
Rate of Intervention Uptake
时间窗: Baseline (Day 0)
This will be reported as the number of participants who are enrolled and assessed for eligibility.
Rate of Intervention Retention
时间窗: Week 12
This will be reported as the number of 12-week survey completers / total enrolled participants.
次要结局
- Change in Waist Circumference (cm)(Baseline, Week 12)
- Change in Weight (kg)(Baseline, Week 12)
- Change in Neck Circumference (cm)(Baseline, Week 12)
- Change in Blood Pressure (BP)(Baseline, Week 12)
- Change in Yale Food Addiction Scale (YFAS)(Baseline, Week 12)
- Change in Food Cravings Questionnaire - Trait (FCQ-T) Score(Baseline, Week 12)
- Change in Hip Circumference (cm)(Baseline, Week 12)