ADAPT+: Optimizing an Intervention to Promote Healthy Behaviors in Rural, Latino Youth With Obesity and Their Parents, Using Mindfulness Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
The purpose of this study is to refine and optimize an obesity intervention with rural underserved Latino children and their parents that combines a standard family-based behavioral approach, the "gold standard" for pediatric obesity treatment, with a mindfulness approach focusing on stress reduction (now ADAPT+).
详细描述
Latino youth have the highest prevalence of obesity as compared to Black or White youth, and are at high risk for adult obesity-related complications including cardiovascular disease. Moreover, Latino youth living in rural communities have an increased risk of adult obesity and mortality due to obesity-related chronic disease than Latinos living elsewhere. The investigators synthesized the prior childhood obesity intervention and tailored the evidence informed, theory-based, multi-family behavioral intervention, Adapting Diet and Action for Everyone (ADAPT), to the acculturation status, language, and national origin of the target population - obese, school-aged (8-12 years old) Latino youth and their parents living in rural areas. However, because the role of parent stress on obesity has not been adequately addressed in interventions aimed at reducing obesity in Latino youth, it is argued that mindfulness parent stress reduction strategies may be a key component to improving eating and physical activity (PA) behaviors in both children and their parents. This study proposes a refinement and optimization of the original ADAPT obesity intervention protocol to include mindfulness parent stress reduction strategies (now ADAPT+) and feasibility assessment of ADAPT+ implementation.
Aim 1: Refinement of ADAPT+ (ADAPT + mindfulness parent stress reduction). Aim 1A and Aim 1B were focus groups with promotoras from the target communities and parents. The intervention manual was refined based on the qualitative feedback. Aim 1C further refines the manual via a small one parent-child cohort. Data collected at Aim 1C was used to finalize and optimize a culturally acceptable ADAPT+ evaluated in Aim 2.
Aim 2: Feasibility and Acceptability trial. A randomized trial testing feasibility of ADAPT+ vs. Enhanced Usual Care (EUC) conducted in two rural communities. It is anticipated that compared to EUC, ADAPT+ dyads will have a lower attrition rate and will report greater satisfaction. The investigators also explore whether the eating and stress indices are sensitive to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child with a BMI %ile of 85 or higher.
- •The target parent is at least 18 years old, is the main meal preparer, speaks and reads Spanish at a minimum of a 4th grade reading level (able to follow basic instructions in Spanish), and able to perform simple physical exercises.
排除标准
- •A child who has a medical/developmental condition that precludes weight loss using conventional diet and PA methods.
- •A child has been on antibiotics or steroids in the previous three months.
- •The parent is ineligible if he/she is non-ambulatory, is pregnant, or has a medical condition that may be negatively impacted by PA.
结局指标
主要结局
Acceptability
时间窗: 6 weeks after baseline
Acceptability was measured by a program satisfaction survey at the end of the intervention. Items were rated on a scale from 1 (Not at all) to 4 (Very) enjoyable, comfortable, receptive, relevant, or helpful, depending on the item's content. A mean score was calculated using all items to reflect overall satisfaction, with higher scores indicating greater satisfaction. Only parents completed the program satisfaction survey. Minimum score: 1 Maximum score: 4 Higher scores mean better outcomes.
Feasibility - Number of Participants Attending 75%+ Sessions
时间窗: 6 weeks after baseline
Number of participants who completed at least 75% of the program sessions. This was done at the parent/dyad level.
Retention Over Time (From Baseline to 3-month Follow-up)
时间窗: From baseline to 3-month follow-up
Percentage of families retained for 3-month follow-up assessment
Retention Over Time (From Baseline to Post-assessment)
时间窗: From baseline to post-assessment (6-weeks)
Percentage of families retained for post-intervention assessment
Feasibility - Accrual Rates
时间窗: 6 weeks after baseline
Percent of families approached who agreed to participate. This was done at the parent/dyad level.
次要结局
- Child BMI z Score (3-month Follow-up)(3-month Follow-up (3 months after Post-Assessment))
- Parent BMI (Post-Assessment)(Post-Assessment (6 weeks after Baseline))
- Perceived Stress Scale (PSS) [3-month Follow-up](3-month Follow-up (3 months after Post-Assessment))
- Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment)(Post-Assessment (6 weeks after Baseline))
- Child Waist-to-Hip Ratio (Post-Assessment)(Post-Assessment (6 weeks after Baseline))
- Parent BMI (3-month Follow-up)(3-month Follow-up (3 months after Post-Assessment))
- Parent Waist-to-Hip Ratio (Post-Assessment)(Post-Assessment (6 weeks after Baseline))
- Child BMI z Score (Post-Assessment)(Post-Assessment (6 weeks after Baseline))
- Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment)(Post-Assessment (6 weeks after Baseline))
- Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up)(3-month Follow-up (3 months after Post-Assessment))
- Parent Waist-to-Hip Ratio (3-month Follow-up)(3-month Follow-up (3 months after Post-Assessment))
- Latino Dietary Behaviors Questionnaire (Post-Assessment)(Post-Assessment (6 weeks after Baseline))
- Child Waist-to-Hip Ratio (3-month Follow-up)(3-month Follow-up (3 months after Post-Assessment))
- Perceived Stress Scale (PSS) [Post-Assessment](Post-Assessment (6 weeks after Baseline))
- Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up)(3-month Follow-up (3 months after Post-Assessment))
- Latino Dietary Behaviors Questionnaire (3-month Follow-up)(3-month Follow-up (3 months after Post-Assessment))