A Hybrid Mobile Phone Family Intervention to Prevent Childhood Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Child BMI
研究概览
简要总结
Consumption of sweetened beverages, media-viewing, and physical activity patterns are often established during early childhood, and family-based obesity interventions show effectiveness in shaping healthy behaviors and weight outcomes for young children, including Latino children. Missing from these interventions, however, are methods to increase accessibility and dissemination to multiple family caregivers. The proposed work will use a randomized study design to evaluate the impact a family-based early childhood obesity intervention for Latino families that incorporates evidence-based strategies of in-person childhood obesity interventions, mobile phones, and leverages important determinants of Latino health (e.g. familism, language) in order to decrease ethnic disparities in childhood obesity and cardiovascular risk.
详细描述
Research Design The proposed research design is a prospective randomized controlled trial to evaluate the effectiveness of a family-based childhood obesity intervention that uses a "hybrid" approach of in-person and mobile phone components compared to usual WIC care. Approximately, 260 families (130 in each of the groups and oversampled for a 30% attrition rate) will be recruited from WIC centers in Los Angeles County in the neighborhoods of East Los Angeles, where >95% of clients are of Mexican descent, and from MacArthur Park ("Little Central America") near downtown Los Angeles, where > 80% of clients are of Central American descent. These WIC centers which serve over 5,000 individuals per month (4,000 Latino children) will ensure a sufficient number of Latino participants and ethnic diversity within the Latino population.
Recruitment Eligibility to participate will be open to adult caregivers of a young child who meet study inclusion and exclusion criteria. Eligible caregivers will be randomly assigned to the intervention or usual care arm. To enroll and retain study subjects in both arms, each caregiver will receive $25 gift cards per data collection point, and a higher amount at 12-months ($35) to minimize attrition. All recruitment, enrollment, and incentive strategies will be vetted by IRB.
Study Randomization Study randomization will occur after baseline data collection. A computer-generated permuted block randomization scheme with a block size of 4 will be used to ensure balanced treatment allocation within strata based on child overweight and obesity status, and caregiver structure. These caregiver structure groups will be: (1) two caregivers in same household; (2) two caregivers in different households; and (3) single parent without a second caregiver to participate (although anticipate a very small percentage in this group as neighborhood demographic data indicate >70% two-caregiver households). Single parents will be reminded that former spouses, extended family, friends, and other caregivers are eligible and encouraged to participate.
Intervention Group The intervention will include in-person and mobile phone components focusing on Latino caregivers of young children, to support evidence-based and age appropriate dietary, media-viewing, and physical activity practices among 2- to 5-year old children, in order to decrease ethnic disparities in childhood obesity. The intervention is 4-week in-person sessions plus mobile phone component, followed by 2-motnsh of mobile phone "booster" messages to reinforce content.
Usual Care Control Group After enrollment into the study and completion of baseline data, caregivers will be randomly assigned into the intervention or control arm of the study. Both groups of caregivers will continue to receive ongoing usual care through WIC. WIC "usual care" for caregivers of 2- to-5-year-olds includes: (1) monthly vouchers for nutritious food; (2) individual nutrition counseling at least twice per year; (3) nutrition education two times per year (1:1 counseling or online modules); and (4) referrals to family services.
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
Research assistants who will collect surveys and measurement data will be blinded to participation condition.
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
- •Adult caregivers of a young child who:
- •self-identify as an individual of Latino descent
- •have a 2- to 5-year-old child/grandchild who is overweight or obese, defined as having a BMI>85% for age and sex
- •lives with or cares for the child at least 20 hours per week (the relationship does not have to be biological
- •speaks Spanish or English
- •ability and willingness to participate in the intervention (determined with a Subject Comprehension and Participation Assessment Tool)
- •agrees to complete baseline, 1-, 6-, 12-month post-intervention data collection protocols
排除标准
- •Caregivers of a child with:
- •medical conditions related to overweight status such as Prader-Willi Syndrome
- •taking weight loss medication
- •participating in a weight loss program.
结局指标
主要结局
Child BMI
时间窗: change in baseline and 12-month post baseline
BMI in kg/m\^2 based on measured weight in kg and height in meters. A lower BMI from baseline is a better outcome.
次要结局
- Role modeling healthy behaviors(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
- Caregiver/parent BMI(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
- Media Viewing Practices(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
- Child Physical Activity Patterns(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
- Dietary Intake(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
- Latino toddler eating and dietary practices(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
- Caregiver/parent dietary intake(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
- Family Cohesion(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
- Caregiver Physical Activity Patterns(baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline)
研究者
Alma Guerrero, MD, MPH
Associate Professor of Pediatrics
University of California, Los Angeles