- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03028233
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
연구 개요
상세 설명
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
The intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.
The Specific Aims are:
Aim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.
Aim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.
Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Worcester, Massachusetts, 미국, 01655
- UMass Medical School
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.
Exclusion Criteria:
- Has an inability or unwillingness to give informed consent or assent
- Is a prisoner
Exclusion (child only)
- The child has been told by a doctor that they cannot walk or eat fruits and vegetables.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Healthy Lifestyles
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention.
Barriers include social, environmental, and family issues.
|
A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
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활성 비교기: Positive Parenting
The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
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A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
child BMI z-score
기간: 2 years
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Weight and height is measured using standard methodology, with children wearing light clothing and no shoes.
Weight is measured to the nearest 0.5 lb on a digital scale.
Height is measured to the nearest tenth of a centimeter using a stadiometer.
BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.
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2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Child Dietary Behaviors: Overall
기간: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
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2 years
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Child Dietary Behaviors for snacks
기간: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
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2 years
|
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Child Dietary Behaviors for Beverages
기간: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
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2 years
|
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Parent Dietary Behaviors: Overall
기간: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
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2 years
|
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Parent Dietary Behaviors for Snacks
기간: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
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2 years
|
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Parent Dietary Behaviors for Beverages
기간: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
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2 years
|
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Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
기간: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
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2 years
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Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
기간: 2 years
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This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
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2 years
|
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Child Physical Activity and Sedentariness: ActiGraph GT1M
기간: 2 years
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Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged.
This measure provides data on intensity and duration of activities.
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2 years
|
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Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
기간: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
|
Parent physical activity and sedentariness: C-PAQ and PAQ-C
기간: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
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2 years
|
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Parent physical activity and sedentariness: ActiGraph GT1M
기간: 2 years
|
Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged.
This measure provides data on intensity and duration of activities
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2 years
|
|
Parent BMI
기간: 2 years
|
BMI is calculated with weight and height measurements using standard methodology.
Weight is measured to the nearest 0.5 lb on a digital scale.
Height is measured to the nearest centimeter using a stadiometer.
BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.
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2 years
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Child utilization of built environment resources
기간: 2 years
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Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (~size of a matchbox) when wearing an accelerometer.
The GPS unit records the geographic coordinates of the child's activities.
Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained.
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Milagros C Rosal, PhD, UMass Medical School
- 수석 연구원: Wenjun Li, PhD, UMass Medical School
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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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