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临床试验/NCT02292602
NCT02292602已完成不适用

Developing a Preschool Obesity Intervention for Families Enrolled in WIC

Wayne State University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Perceived acceptability of the program at post-treatment as measured by semi-structured qualitative interviews

研究概览

简要总结

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a community and home-based preschool obesity intervention for families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

详细描述

Very few studies have targeted weight control in preschoolers even though the prevalence of overweight has exceeded 20% in this age-group for the past decade. Also concerning is that few studies have focused on preschoolers from low-socioeconomic (SES) backgrounds despite persistent obesity-related socioeconomic disparities. Family-based, behavioral interventions appear a promising model for treatment of obesity in early childhood. However, the dissemination potential of these programs is unclear as they have primarily been tested with families from middle-to-upper class backgrounds and within research settings. Identifying effective approaches to weight control for preschoolers from low-SES backgrounds that can be delivered in community settings is imperative to reducing the pediatric obesity epidemic. The proposed study will begin to address this critical gap by completing the second phase of developing a community-based preschool weight control intervention for families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The proposed study is significant because we specifically target preschool weight control in a high-risk population and because delivery of our program within the WIC program is conducive to its dissemination. Based upon our formative work, and existing preschool obesity programs, we have developed a 14-session, family-based preschool weight control intervention (FBWC) that emphasizes experiential learning and is delivered in the WIC and home settings. Seventy-two overweight and obese preschool-caregiver dyads will be randomized in a 2:1 ratio to receive FBWC or to continue with standard of care at WIC (WSOC). The primary study aims are to a) examine the feasibility and acceptability of FBWC and b) explore the preliminary efficacy of FBWC compared to WSOC on reduction in preschooler BMI-z-score and caregiver BMI from baseline to post-treatment (4-months) and 7-months (3-month follow-up). An exploratory aim is to evaluate lifestyle and behavioral indicators of intervention success. This study is innovative because: 1) very few studies have examined obesity intervention in preschoolers, 2) we target weight control in a high-risk group that has been underrepresented in the preschool obesity treatment outcome literature, 3) our intervention is community-based, and 4) we emphasize experiential learning as a strategy for achieving lifestyle behavior change and weight control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
24 Months 至 55 Months(Child)
性别
All
接受健康志愿者

入选标准

  • family receiving services at Detroit-based WIC clinics
  • preschooler between the ages of 2 years and 4 years, 7 months and BMI>85th percentile
  • one primary caregiver who is willing to participate and whose BMI>25
  • family is English-speaking
  • preschooler has medical clearance to participate in the intervention
  • caregiver has medical clearance to participate in the intervention if indicated by physical activity screening questions

排除标准

  • preschooler or caregiver is participating in a different weight management program
  • preschooler or caregiver has a condition that precludes participation in moderate level activity
  • preschooler or caregiver is diagnosed with a weight-affecting health condition
  • preschooler or caregiver is taking weight-affecting medications
  • preschooler or caregiver is diagnosed with a developmental delay or disability
  • caregiver is receiving treatment for severe psychopathology
  • family plans to be out of town for more than 2 weeks of the first 4 months of their research participation
  • family plans to move from Detroit in the next 7 months

结局指标

主要结局

Perceived acceptability of the program at post-treatment as measured by semi-structured qualitative interviews

时间窗: 4 months

Semi-structured qualitative interviews will be conducted with a randomly selected subset of families completing the intervention (n=12) to determine whether the intervention met their needs.

Perceived acceptability of the program at follow-up

时间窗: 7 months

Semi-structured qualitative interviews will be conducted with a randomly selected subset of families completing the intervention (n=24) to determine whether intervention content facilitated sustained change.

Change in and caregiver BMI

时间窗: baseline, 4 months, 7 months

based upon height and weight

Feasibility (attendance and attrition)

时间窗: 4-months

mean number of sessions attended and number of families who dropped out of the intervention

Change in preschooler BMI z-score

时间窗: baseline, 4 months, 7 months

based upon height and weight

次要结局

  • Change in preschooler diet(baseline, 4-months, 7-months)
  • Change in caregiver feeding(baseline, 4-months, 7-months)
  • Change in home food environment(baseline, 4-months, 7-months)
  • Change in preschooler activity(baseline, 4-months, 7-months)
  • Change in caregiver diet(baseline, 4-months, 7-months)
  • Change in caregiver activity(baseline, 4-months, 7-months)
  • Change in caregiver stress(baseline, 4-months, 7-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Kuhl

Assistant Professor of Pediatrics

Wayne State University

研究点 (2)

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