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临床试验/NCT02365324
NCT02365324已完成不适用

PAWS CLUB: Peer Education About Weight Steadiness

University of Illinois at Urbana-Champaign8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
8
主要终点
Changes in 24-hour dietary intake recall

研究概览

简要总结

The proposed integrated project will evaluate the effects of an evidence-based extension education program, Family Fitness Program (FFP) grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), with and without a peer-education mode of delivery on balancing calories to manage body weight (BW), reducing certain foods and food components, increasing selected foods and nutrients, building healthy eating patterns [i.e., fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010] and SCT variables. Briefly, the 12-week program will target early adolescent children, ages 11-14 years, test a peer-education approach to behavioral change and will be delivered as an after-school program in local middle schools in support of childhood obesity prevention. Data will be collected at baseline (preintervention), after the 12-week program (post-intervention) and 6 months after completion of the program (maintenance).

详细描述

The 12-week intervention, either Family Fitness Program, FFP (adult-led control group) or Peer-education Family Fitness Program, PE-FFP (peer-led experimental group) will be delivered four times in each of the three schools participating in the study from May, 2015 to May 2017 as an after-school program to early adolescent children, ages 11-14 years, to partially meet the stated objectives in research. The proposed integrated project will follow a group-randomized controlled trial design. The intervention will be offered as an after-school programs in each of 3 schools (Urbana Middle School, Franklin Middle School and Mahomet Seymour-Junior High School). Programs will be conducted on Mondays, Tuesdays, Wednesday, and Thursdays for 12 weeks. After children are enrolled in the program, weekday by school will be randomly assigned to the adult-led FFP (control group) or to the peer-led PE-FFP (experimental group). This process will allow children the convenience of participating in the program on the day that is most compatible with their schedules, offer the control and experimental conditions at each of 2 schools and maintain randomization to treatment. Thus, each school will have 1 control group and 1 experimental group each time the program is conducted. Group randomization will occur during the fall-winter 2016 term and spring-summer 2017 term again. Data will be collected at baseline (pre-intervention), after the 12-week FFP or PE-FFP (post-intervention) and 6 months after completion of the program (maintenance). The FFP addresses all major elements of the Dietary guidelines for Americans (DGAs), 2010. Each weekly lesson will include: 1) 20-30 minutes of moderate physical activity; 2) nutrition activities; 3) discussions; 4) self-reflections; 5) goal setting activities for healthier eating and physical activity; 6) food and beverage tasting experiences; and 7) parent-child reflections. Lesson details are provided below. Incentive items will be distributed throughout the 12-week intervention. Adult educators will lead FFP lessons, while peer-educators will lead PE-FFP lessons. Study personnel will be present at each lesson, along with Illinois-Trans-disciplinary Obesity Prevention Program (I-TOPP) trainees to monitor each session and to conduct extension measures.

Lesson details:

  1. Introduction to Fitness; For children: Introductions; ice-breakers; health and wellness; family physical activities and foods Energy balance; physical activity environment; body image; vegetables and fruits; family fitness For parents: An Introduction to family Fitness
  2. Culinary Skills; For children: Knife safety; knife selection; cooking methods and utensils; focus on vegetables and fruits
  3. Culinary Skills in Action; For children: Slicing, measuring, tasting vegetables and fruits; vegetable and fruit dishes
  4. Physical Activity: Using Dietary Guidelines for Healthy Food Choices; For children and parents: Balancing calories to manage weight; energy; growth and development; growth charts; family physical activity values; building healthy eating patterns; nutrient-dense foods; flexible food patterns; vegetables and fruits; whole grains; seafood; family food choices; family food values
  5. Breakfast for All; For children and parents: Increasing specific foods and nutrients; whole grains; vegetables and fruits; nutrients of concern (dietary fiber and potassium); flexible food patterns; family eating patterns; finding family time for healthy food choices and physical activities
  6. Healthy Snacking and Healthy Food Choices; For children: Reducing certain foods and food components; energy-dense foods; solid fats and added sugars; sodium; refined grains; label reading (Nutrition Facts label); goal setting for food and snack choices; family snack choices For parents: Identifying and Overcoming Resistance to Change
  7. Eating Out and Fast Foods; For children: Reducing certain foods and food components; label reading; menu reading; finding fats and oils; portion sizes; food advertising; food environment; eating at home with family or eating out choices
  8. Healthy Beverages; For children: Increasing specific foods and nutrients; non-fat milk and dairy; water; nutrients of concern (calcium and vitamin D); food and health connections; practicing culinary skills
  9. Setting Limits on Sweets and Fats; For children: Reducing certain foods and food components; finding fats and sugars in foods; practicing culinary skills; goal setting for food choices
  10. Maintaining Physical Activity and Healthy Eating Patterns; For children: Balancing calories to maintain weight; Building healthy eating patterns; flexible approaches to eating; variety, balance and moderation; label reading; vegetables and fruits; whole grains; non-fat milk and dairy; seafood; oils; physical activities for the family
  11. Family Menu Planning; Family food preferences and health needs; food costs and budgeting; family menus; shopping lists; family food purchasing
  12. Grocery Shopping; For children: Field trip; in-store choices and selections; food costing; Wrap-Up

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children in grade 6 or grade 7, 11-14 years old and their parents, enrolled in the schools participating in the study

排除标准

  • Children younger than 11 years or older than 14 years, not enrolled in the schools participating in the study

研究组 & 干预措施

Peer-education Family Fitness Program

Experimental

Peer educators (children in grade 8) recruited from the schools participating in the study will be trained and will then be implementing the 12 week Peer-education Family Fitness Program (PE-FFP) intervention to children in 6th and 7th grade.

干预措施: Peer-Education Family Fitness Program (PE-FFP) (Behavioral)

Family Fitness Program (FFP)

Other

Adult educators recruited from the University of Illinois Extension or the community will be trained and will then be implementing the 12 week Family Fitness Program (FFP) intervention to children in 6th and 7th grade.

干预措施: Family Fitness Program (FFP) (Behavioral)

结局指标

主要结局

Changes in 24-hour dietary intake recall

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

24-hour dietary intake recall completed by the multiple-pass method in an interview format.

Changes in 24-hour physical activity recall

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

Average energy expenditure of children (kcals/day) will be estimated from 1, 24-hour physical activity recall completed in an interview format.

Changes in 3-day physical activity record

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

3-day physical activity record (2 weekdays+1 weekend day).

Changes in Anthropometric measurements

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

In a private room with the child's parent present, a graduate research assistant (GRA) will measure the child's BW (kg) on a calibrated scale (Seca 700, Hanover, MD) to the nearest 0.1 kg and body height (cm) to the nearest 0.1 cm with a calibrated, standing stadiometer (Seca 700).

Change in Demographic data

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

Children will complete a standardized questionnaire to provide age, gender, race/ethnicity, grade level and home address. Information about health (any acute or chronic illnesses) and health care services utilization (frequency of doctor's visits, use of specialists, medication use or need) will be provided by parents.

Goal setting tool

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

Children and parents will complete the Goal Setting for Family Fitness tool. Children and adults, respectively, will complete the Child or Adult versions of the Pre-Survey (baseline), Post-Survey (post-intervention) and Follow-Up Survey (6-months post-intervention).

Changes in 3-day dietary intake record

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

3-day dietary intake record (2 weekdays+1 weekend day).

Changes in Social Cognitive Theory (SCT) variables

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

Social/family support, self-efficacy, self-regulation and outcome expectations for balancing calories to manage BW, reducing certain foods and food components, increasing selected foods and nutrients and building healthy eating patterns will be assessed by questionnaires.

Changes in blood pressure (BP) measurements

时间窗: Evaluation at three time points: 0 months, 2 months and 8 months

Seated systolic and diastolic BP (mmHg) will be measured by a trained GRA, using a sphygmomanometer (Baumanometer® Desk Model, Copiague, NY). Two BP measurements will be recorded with a 3-minute rest period between readings; values will be averaged.

次要结局

  • Extension measures(Once, at the end of the 12 week intervention)
  • Education measures(Once, at the end of the 12 week intervention)
  • Process measure questionnaire(One questionnaire for each of the 12 sessions of the program (An average of six to twelve weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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