Supporting Together Exercise and Play and Improving Nutrition (STEP IN)
2020年11月13日 更新者：Children's Hospital Medical Center, Cincinnati
Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.
調査の概要
詳細な説明
In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity.
The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time
研究の種類
介入
入学 (実際)
36
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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Ohio
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Cincinnati、Ohio、アメリカ、45229
- Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center
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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
6年～12年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)
- BMI is greater than 85th%ile for age and sex
- English speaking
- have access to a computer/internet or a smart phone (for uploading Fitbit data)
Exclusion Criteria:
- Have been seen in a weight management clinic within the last 2 years
- prescribed an atypical antipsychotic
- non-ambulatory
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：非ランダム化
- 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 |
|---|---|
|
実験的：Biweekly Arm
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place biweekly.
|
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
他の名前：
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
|
|
実験的：Monthly Arm
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place monthly.
|
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
他の名前：
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
|
|
実験的：Weekly
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place weekly.
|
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
他の名前：
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
|
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 |
|---|---|---|
|
Attendance
時間枠：Baseline, 3 months
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Evaluation of participant attendance in each arm.
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Baseline, 3 months
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Overall Satisfaction With Group Nutrition Sessions
時間枠：Baseline, 3 months
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Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
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Baseline, 3 months
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Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
時間枠：Baseline, 3 months
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Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases.
Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
|
Baseline, 3 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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PedsQL (Pediatric Quality of Life Inventory)
時間枠：Baseline, 3 months
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Measure Description: PedsQL (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related Quality of Life.
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Baseline, 3 months
|
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BMI Z-Score
時間枠：Baseline, 3 months
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BMI Z-scores compares child to age and sex matched peers.
A z-score of 0 is the same as a 50th percentile in the reference population, a z-score of ± 1.0 plots at the 15th or 85th percentiles, respectively, and a z-score of ± 2 plots at roughly the 3rd or 97th percentiles.
Negative numbers indicate values lower than the reference population whereas positive numbers indicate values higher than the reference population.
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Baseline, 3 months
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Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
時間枠：baseline, 3 months
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The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
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baseline, 3 months
|
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Child Self-efficacy Related to Physical Activity
時間枠：Baseline, 3 months
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Self efficacy was assessed using a validated 14-item questionnaire using a 5-point Strongly Agree/ Strongly Disagree scale.
The range of values is 1 to 5, with lower values indicating higher self-efficacy
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Baseline, 3 months
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Child Intention to be Active
時間枠：baseline, 3 months
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Child intention to be active was assessed with a 1-item questionnaire developed and validated by Saunders et al.
This item uses a 5-point scale, with possible range of scores being 1 to 5. Higher scores indicate greater intention to be active.
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baseline, 3 months
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Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
時間枠：Baseline, 3 months
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Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases.
Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
|
Baseline, 3 months
|
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：Kristen A Copeland、Children's Hospital Medical Center, Cincinnati
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6月1日
一次修了 (実際)
2018年10月1日
研究の完了 (実際)
2018年12月1日
試験登録日
最初に提出
2016年3月14日
QC基準を満たした最初の提出物
2016年3月25日
最初の投稿 (見積もり)
2016年3月31日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月27日
QC基準を満たした最後の更新が送信されました
2020年11月13日
最終確認日
2019年1月1日
詳しくは
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