Efficacy Trial of a Program for Weight Loss for Hispanic Fathers and Increased Physical Activity for Their Children: Healthy Dads, Healthy Kids
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Child´s moderate to vigorous physical activity (MVPA)
研究概览
简要总结
Hispanic men and children experience health disparities for overweight and obesity-related medical conditions, and therefore family level obesity prevention programs for Hispanic populations are needed. 'Healthy Dads Healthy Kids' is the first program to primarily target fathers for obesity prevention for themselves and their children, with significant and clinically relevant treatment effects. This is an efficacy trial to assess a culturally adapted 'Healthy Dads Healthy Kids' for Hispanic families.
详细描述
Hispanics in the United States face health disparities for obesity and related medical conditions, such as cardiovascular disease and diabetes. Targeting families to promote healthy lifestyle behaviors has been identified as an effective strategy to prevent obesity. With the importance of familism (family cohesion) among the Hispanic population, a family based intervention is especially desirable as an engaging strategy to promote behaviors that support a healthy weight status and decrease obesity related health disparities for Hispanics. Emerging evidence supports the need to include and target fathers in family based lifestyle behavior interventions. Healthy Dads Healthy Kids (HDHK) is an evidence based program developed in Australia, shown to have significant weight and behavior treatment effects for fathers and their children, compared to controls. The HDHK program is based on Social Cognitive Theory and Family Systems Theory and aims to promote increased physical activity and improved dietary intake for fathers and their children. An important innovation in the program is that fathers and children attend together and are both targeted as agents of behavior change for each other (reciprocal reinforcement) and to participate in fun, family activities together. HDHK was culturally adapted for Hispanic families following the Ecological Validity Model by this research team, with input from a community Hispanic family panel, expert committee and the developer of the HDHK program. The resulting Papás Saludables, Niños Saludables (PSNS) program is a 10-week group-based intervention that meets weekly.
This randomized controlled trial of PSNS is powered to detect a clinically meaningful change in father's weight and children's moderate to vigorous physical activity. The study will also assess other behavioral (dietary intake, sedentary time, screen media use, and parenting practices), psychosocial (familism, acculturation, and co-parenting alliance) and biological (child BMI z-score, father's non-HDL, HgbA1C, and BP) outcomes. Hispanic men with overweight or obesity who are a father figure (biological father, step father, grandfather, adult older brother, etc) to a 5-11 child will be enrolled in the study in waves. Participants are enrolled as a family unit and includes the father, child(ren) (up to 3 siblings) and mother/partner (if available). After screening and baseline data is complete for a wave, the family is randomized to receive a standard of care control or the group-based culturally adapted PSNS. Follow-up assessments will be done at 4 months and 12 months.
The study includes a partnership with the YMCA of Greater Houston to provide a venue for where to deliver the program.
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)
盲法说明
Staff involved in assessment will be masked to participant allocation.
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Known diagnosis of diabetes without medical clearance from health care provider;
- •Known diagnosis of cardio-vascular disease (cardiac arrhythmia, h/o myocardial infarction, heart valve disease, heat failure, heart transplantation, congenital heart disease, h/o heat surgery, coronary angioplasty, or stroke)
- •Currently, or in the past 6 months, in a weight management program
- •Currently, or in the past 6 months, taking medicine that can affect weight or might be affected by weight loss
- •Any other disease or condition affecting their ability to participate in physical activities/exercise (e.g., physical disability, severe asthma)
- •Any other disease or condition affecting their ability to participate in group classroom activities including cognitive impairment (e.g., Down's syndrome, Fragile X), or psychiatric functioning (e.g. schizophrenia)
- •Plans of moving away from Harris County in the next year
- •Not passing the 2015 American College of Sports Medicine's exercise participation health screener AND NOT provide a medical clearance from a licensed medical provider (MD, NNP, PA)
- •Unwilling to wear accelerometer for a 7 day study period at the three assessment points.
- •BMI less than 25 or greater than
- •HbgA1C equal or greater than 6.5% at baseline data collection without medical clearance from health care provider.
- •Has previously participated in studies on the Healthy Dads Healthy Kids' for US Hispanics
- •History of myocarditis from COVID infection or vaccine
- •Not within the 5-11 year old child age range
- •Known diagnosis of diabetes
- •Known diagnosis of cardio-vascular disease (cardiac arrhythmia, h/o myocardial infarction, heart valve disease, heat failure, heart transplantation, congenital heart disease, h/o heat surgery or coronary angioplasty)
- •Inability to participate in regular physical education classes in school due to health or physical condition (e.g. physical disability, severe asthma)
- •Any disease or condition affecting their ability to participate in group classroom activities including cognitive impairment (e.g. Down's syndrome, Fragile X), or developmental problems (e.g. autism spectrum disorder)
- •Any Known diagnosis of an eating disorder (e.g. anorexia nervosa, bulimia nervosa, etc.) MOTHER
- •No father figure to her children enrolled in the study
结局指标
主要结局
Child´s moderate to vigorous physical activity (MVPA)
时间窗: 12 months
MVPA will be measured by Actigraph accelerometer with a minimum of 4 days of data 600 min/day
Father´s weight
时间窗: 12 months
weight in kg
次要结局
- Father´s weight(4 months)
- Child´s MVPA(4 months)
- Co-parenting alliance(4 and 12 months)
- Father's HgbA1C(4 and 12 months)
- Child's and father's sedentary time(4 and 12 months)
- Father´s MVPA(4 and 12 months)
- Father's blood heart rate(4 and 12 months)
- Father's blood pressure(4 and 12 months)
- Fathers's non-HDL(4 and 12 months)
- Child´s and father's dietary intake(4 and 12 months)
- Father-child bonding(4 and 12 months)
- Father's food and physical activity parenting practices(4 and 12 months)
- Child's BMI z-score(4 and 12 months)
- Child´s and father's screen media use(4 and 12 months)
研究者
Teresia O'Connor
Professor of Pediatrics
Baylor College of Medicine