Family Inclusive Childhood Obesity Treatment Designed for Low Income and Hispanic Families
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 554
- 试验地点
- 4
- 主要终点
- Change in Body Mass Index (BMI) %95 in children with obesity (treatment)
研究概览
简要总结
This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with obesity and their families will be referred to the study by primary care providers and randomized to HeLP or RTOP. The clinical setting is a practice-based research network serving majority Hispanic and Medicaid-insured populations. The intensive phase and booster sessions of HeLP will take place at recreation centers located near the clinics and will be led by health educators employed by the clinics. Visits with primary care providers (PCPs) for HeLP maintenance or RTOP will occur at the clinics.
详细描述
This study is a Randomized Controlled Trial (RCT) to learn about how well a family childhood weight management program works compared to healthy lifestyle counseling by providers at participating clinics. The goal is to compare weight change in children with obesity from low-income predominantly Hispanic/Latino families that will participate in the program, the Healthy Living Program (HeLP) vs. Recommended Treatment of Obesity in Primary Care (RTOP). Low-income children with obesity from mostly Hispanic clinical populations will be referred to the project by their primary doctors and will be enrolled into either HeLP or RTOP. Families (including siblings and caregivers) who are in HeLP will be offered 12 sessions at local rec centers where health educators and fitness trainers will teach them about parenting skills, nutrition, fitness, and mindfulness. Families who are in RTOP will receive an enhanced version of the care that is usually provided at their primary care clinics. Providers will be trained in a skill called Motivational Interviewing and use an electronic tool called "HeartSmartKids" to help families make healthy lifestyle changes. Families who are in RTOP will go to follow-up visits every 3 months and will go to HeLP after 18 months.
Aim 1 (Treatment): To compare the BMI change relative to the 95th percentile for age and sex in children with obesity in 3 different age groups (2-6, 7-12, and 13-16 years old) 18 months after being in either HeLP or RTOP.
Aim 2 (Prevention): To compare the weight change in healthy and unhealthy weight 2-6-year-old children who have siblings with obesity and are in either HeLP or RTOP.
Aim 3 (Implementation): To describe implementation processes of HeLP and RTOP using a framework called RE-AIM: R-Reach: Is the project reaching the people it needs to reach? E-Effectiveness: Is the program effective? A-Adoption: are the health educators, providers, and clinics promoting and doing the program? I-Implementation: Are the health educators, providers and clinics delivering the intervention as intended? M-Maintenance: Is the intervention working to help children with their weight and healthy lifestyle changes? The cost of delivering the program will also be studied to inform potential sustainability.
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
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child aged 2-16yrs
- •With overweight or obesity (BMI >85th percentile)
- •Referred by PCP
- •Primary Adult Caregiver
- •Up to two siblings of any BMI status (if multiple siblings are available, enrollment goals stratified by age and BMI will be used to select siblings for enrollment.)
排除标准
- •Parent without fluency in either Spanish or English
- •Current participation in a clinically referred obesity treatment program
- •Child non-ambulatory, non-verbal, or diagnosed with a genetic syndrome associated with obesity.
- •Children with severe depression on initial screening (CES-D >/=40 or suicidal ideation) will be excluded and referred to psychiatric treatment and therapy.
- •Children who have been diagnosed by PCP at time of initial screening with severe comorbidities of obesity, including:
- •Type 2 diabetes
- •Stage 2 hypertension
- •Severe hyperlipidemia
- •Severe obstructive sleep apnea will be excluded from the study and directed to the only Tertiary Care Childhood Obesity Treatment program in the state of Colorado: Lifestyle Medicine at Children's Hospital Colorado.
结局指标
主要结局
Change in Body Mass Index (BMI) %95 in children with obesity (treatment)
时间窗: From Baseline to Month 18
Change in BMI%95 as measured in 2-16 yr old children with obesity BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the Centers for Disease Control (CDC) program for Statistical Analysis System (SAS).
Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)
时间窗: From Baseline to Month 18
Change in BMI%95 as measured in healthy and overweight 2-11 yr old siblings of the children with obesity. BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the CDC program for SAS.
次要结局
- Change in Body Mass Index (BMI) %95 in children with obesity (treatment)(From Baseline to Month 12)
- Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)(From Baseline to Month 12)
- Change from Baseline in food insecurity at 18 months as measured by the US Department of Agriculture (USDA) Household Food Security Survey scores(Baseline, Month 18)
- Change from baseline in Disinhibition at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents(Baseline, Month 18)
- Change from baseline in Cognitive Restraint of Eating at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents(Baseline, Month 18)
- Change in nutrition aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)(Baseline, Month 18)
- Change in physical activity and media aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)(Baseline, Month 18)
- Change from Baseline in Hemoglobin A1c (HbA1c) blood glucose tests at 18 months(Baseline up to Month 18)
- Change from Baseline in Alanine Transaminase (ALT) liver enzyme levels tests at 18 months(Baseline up to Month 18)
- Change from Baseline in Caregiver Waist Circumference (WC) at 12 months(Baseline, Month 12)
- Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 18 months(Baseline, Month 18)
- Change from Baseline in 18 months in levels of Familism as measured by the Pan-Hispanic Familism Scale(Baseline, Month 18)
- Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Me Up child report(Baseline, Month 6)
- Change from Baseline in depressive symptoms in children at 18 months as measured by the Center of Epidemiological Studies Depression Scale for Children 6-12 years (CES-DC)(Baseline, Month 18)
- Reach as measured by the proportion of eligible children seen for well-child care that are randomized.(up to Month 18)
- Change from baseline in Hunger at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents(Baseline, Month 18)
- Change from baseline in physical fitness at 6 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores(Baseline, Month 6)
- Change from baseline in physical fitness at 18 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores(Baseline, Month 18)
- Change from Baseline to 6 months in levels of Familism as measured by the Pan-Hispanic Familism Scale(Baseline, Month 6)
- Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol tests or fasting lipids tests at 18 months(Baseline up to Month 18)
- Change from Baseline in Caregiver Waist Circumference (WC) at 18 months(Baseline, Month 18)
- Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 12 months(Baseline, Month 12)
- Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Me Up child report(Baseline, Month 18)
- Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Them Up Parent report(Baseline, Month 6)
- Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Them Up Parent report(Baseline, Month 18)
- Change from Baseline in depressive symptoms in parents at 6 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)(Baseline, Month 6)
- Change from Baseline in depressive symptoms in parents at 18 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)(Baseline, Month 18)
- Change from Baseline in depressive symptoms in adolescents 12-18 years at 6 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)(Baseline, Month 6)
- Change from Baseline in depressive symptoms in adolescents 12-18 years at 18 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)(Baseline, Month 18)
- Change from Baseline in depressive symptoms in children at 6 months as measured by the Center of Epidemiological Studies Depression Scale for Children 6-12 years (CES-DC)(Baseline, Month 6)
- Adoption as measured by the proportion of training sessions attended by medical providers(up to month 48)
- Primary Care Visit Frequency in the as measured by number of clinic visits for each child(up to month 36)
- Change in history of Coronavirus Disease 2019 (COVID-19) diagnosis status in a parent participant(Baseline, up to month 18)
- Change in history of COVID-19 diagnosis status in a child participant(Baseline, up to month 18)