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).
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다
- The Hospital for Sick Children
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: Control
Attend one-on-one check-ins with the interdisciplinary team at STOMP; wait-listed control group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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zBMI
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mental health
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Parent report focus group
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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