STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity (STOMP)
STOMP Early Years: A Pilot Randomized Controlled Trial of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
This internal pilot study will determine whether a highly promising primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight status in 1 to 5 year old children with severe obesity.
Children with severe obesity will be identified through the obesity management clinical program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity management program designed for 1 to 5 year-olds with severe obesity and their families. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6 months:
Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home visits and four one-on-one check-ins with an interdisciplinary team at STOMP.
Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with an interdisciplinary team at STOMP.
In addition to the measures collected as part of STOMP, families will complete the following questionnaires before the start of the trial, and after 6 months:
Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21), Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ
- The Hospital for Sick Children
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Children with obesity and severe obesity (BMI ≥97th percentile) and at least one parent (primary caregiver), and families who are fluent in English (written and oral) will be eligible to participate.
Exclusion Criteria:
- Children with diagnosed Prader-Willi syndrome; severe developmental delay; and families who reside beyond the Toronto Public Health catchment area for home visiting.
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Parenting education sessions
Receive 10 weeks of group parenting education sessions with 2-4 public health nurse home visits.
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If assigned to the parenting education session group, families will start with the 10-week group parenting education sessions and 2-4 home visits immediately after being enrolled.
During this time, they will also come in for four one-on-one check-ins with the STOMP team.
Each check-in will be approximately 1 hour.
At least one parent/caregiver will attend weekly parenting sessions which will take place at SickKids.
The Toronto Public Health Nurse will arrange 2-4 home visits with the family during the 6 month period of the study.
The home visits will focus on helping to apply the messages and skills from the group sessions in their homes, and making connections in the neighbourhood to recreational or nutrition programs or other supports for the family.
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介入なし：Control
Attend one-on-one check-ins with the interdisciplinary team at STOMP; wait-listed control group.
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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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zBMI
時間枠：6 months post-intervention
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Measure the difference in age and sex-standardized BMI z-score (zBMI)
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6 months post-intervention
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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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Mental health
時間枠：6 months post-intervention
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Assess mental health by Strengths and Difficulties Questionnaire
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6 months post-intervention
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Eating behaviour and dietary intake
時間枠：6 months post-intervention
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Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
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6 months post-intervention
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Parent report focus group
時間枠：6 months post-intervention
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focus group of eligible parents around feasibility and acceptability of the planned intervention
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6 months post-intervention
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
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