Peer Education About Weight Steadiness (PAWS)
2019年9月3日 更新者：University of Illinois at Urbana-Champaign
PAWS CLUB: Peer Education About Weight Steadiness
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).
調査の概要
状態
完了
詳細な説明
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:
- 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
- Culinary Skills; For children: Knife safety; knife selection; cooking methods and utensils; focus on vegetables and fruits
- Culinary Skills in Action; For children: Slicing, measuring, tasting vegetables and fruits; vegetable and fruit dishes
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Family Menu Planning; Family food preferences and health needs; food costs and budgeting; family menus; shopping lists; family food purchasing
- Grocery Shopping; For children: Field trip; in-store choices and selections; food costing; Wrap-Up
研究の種類
介入
入学 (実際)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Illinois
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Champaign、Illinois、アメリカ、61820
- Franklin Middle School
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Champaign、Illinois、アメリカ、61822
- Jefferson Middle School
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Mahomet、Illinois、アメリカ、61853
- Mahomet Seymour-Junior High School
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Urbana、Illinois、アメリカ、61801
- Urbana Middle School
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
11年～14年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Children in grade 6 or grade 7, 11-14 years old and their parents, enrolled in the schools participating in the study
Exclusion Criteria:
- Children younger than 11 years or older than 14 years, not enrolled in the schools participating in the study
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Peer-education Family Fitness Program
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.
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The proposed integrated project will be implemented by peers and will evaluate the effects of an evidence-based extension education program, grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), having 2 arms for the study (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.
他の名前：
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他の：Family Fitness Program (FFP)
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.
|
The proposed integrated project will be implemented by adults and will evaluate the effects of an evidence-based extension education program, grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), having 2 arms for the study (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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Demographic data
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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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.
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Evaluation at three time points: 0 months, 2 months and 8 months
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Goal setting tool
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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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).
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Evaluation at three time points: 0 months, 2 months and 8 months
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Changes in 24-hour dietary intake recall
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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24-hour dietary intake recall completed by the multiple-pass method in an interview format.
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Evaluation at three time points: 0 months, 2 months and 8 months
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Changes in 3-day dietary intake record
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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3-day dietary intake record (2 weekdays+1 weekend day).
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Evaluation at three time points: 0 months, 2 months and 8 months
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Changes in 24-hour physical activity recall
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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Average energy expenditure of children (kcals/day) will be estimated from 1, 24-hour physical activity recall completed in an interview format.
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Evaluation at three time points: 0 months, 2 months and 8 months
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Changes in 3-day physical activity record
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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3-day physical activity record (2 weekdays+1 weekend day).
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Evaluation at three time points: 0 months, 2 months and 8 months
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Changes in Anthropometric measurements
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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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).
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Evaluation at three time points: 0 months, 2 months and 8 months
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Changes in Social Cognitive Theory (SCT) variables
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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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.
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Evaluation at three time points: 0 months, 2 months and 8 months
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Changes in blood pressure (BP) measurements
時間枠：Evaluation at three time points: 0 months, 2 months and 8 months
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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.
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Evaluation at three time points: 0 months, 2 months and 8 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Process measure questionnaire
時間枠：One questionnaire for each of the 12 sessions of the program (An average of six to twelve weeks)
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Program staff will administer the process measure questionnaire at the end of each session (12 sessions) to record information about participant attendance (children and adults), engagement during each weekly lessons and completion of program worksheets, and evaluate adult-educator and peer-educator program fidelity for each session for all control (FFP) and experimental (PE-FFP) groups.
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One questionnaire for each of the 12 sessions of the program (An average of six to twelve weeks)
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Education measures
時間枠：Once, at the end of the 12 week intervention
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The RE-AIM framework will be used as the foundation for measuring education and extension outcomes.
Reach, efficacy, adoption, implementation and maintenance (REAIM) will be measured.
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Once, at the end of the 12 week intervention
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Extension measures
時間枠：Once, at the end of the 12 week intervention
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Reach, Efficacy, Adoption, Implementation and Maintenance of the program will be determined at the end of the 12-week intervention.
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Once, at the end of the 12 week intervention
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Sharon Nickols-Richardson, PhD, RD、University of Illinois at Urbana-Champaign
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年5月1日
一次修了 (実際)
2018年5月1日
研究の完了 (実際)
2018年5月1日
試験登録日
最初に提出
2015年2月2日
QC基準を満たした最初の提出物
2015年2月10日
最初の投稿 (見積もり)
2015年2月18日
学習記録の更新
投稿された最後の更新 (実際)
2019年9月4日
QC基準を満たした最後の更新が送信されました
2019年9月3日
最終確認日
2016年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- UIllinoisUC
- 2012-68001-19652 (その他の助成金/資金番号：USDA National Institute of Food and Agriculture)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。