- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01789671
Peer Counseling in Family-Based Treatment for Childhood Obesity (EPICH)
연구 개요
상세 설명
The current study seeks to test the alternative approach of partnering with families, and more specifically parents who have previously received family-based weight control treatment, to serve as peer interventionists to deliver this treatment to other families. Peer-led interventions, common for other health behaviors among adults, has not been previously developed or tested for family-based pediatric weight control intervention. Peer-delivered interventions considerably reduce the high costs of delivering behavioral interventions and could increase the availability of those able to deliver the intervention. In fact, peer interventionists' may be better able to deliver intervention than professionals to families, given these peers have faced similar challenges and barriers to behavior change within their own families. It is also possible that continued engagement in the behavior change process through delivering this intervention to other families could improve peer interventionists' own family's long-term health behaviors and outcomes.
Before utilizing a peer delivery approach more broadly, the novel approach of peer-delivered intervention requires development of training/supervision for peer interventionists and initial evaluation of acceptability/feasibility and efficacy. Therefore, this project has the following aims:
- To develop procedures for training and supervising of parents to be peer interventionists, based on our prior intervention delivery experience and family advisory board input
- To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention
- To compare change in weight and health behavior outcomes of overweight/obese children and parents receiving peer- versus professionally-delivered intervention
This study begins to address the high cost and limited availability of the needed, but intense, family-based pediatric weight control intervention required for efficacy. This approach expands the interdisciplinary nature of this work by engaging the resources and assets of previously treated families to contribute to the reduction of the burden of childhood obesity. Led by a project director (Saelens) and intervention coordinator (Scholz) with over 20 years of combined experience in family-based pediatric weight control intervention, this project moves this intervention in a different and important direction.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98121
- Seattle Children's
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Child age: 7-11 years at time of enrollment
- Overweight child: at or above 85th percentile for age- and gender-specific BMI.
- At least one overweight parent (BMI≥ 25.0).
- Parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment.
- Must live within 50 miles of the treatment center.
Exclusion Criteria:
- Current enrollment in another weight control program for the participating child or parent.
- The participating parent is pregnant.
- Thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child.
- Inability of the child to comprehend English at a 1st-grade level or participating parent to comprehend English at an 8th-grade level.
- Physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity.
- Medication regimen for the child that affects his or her weight.
- Conditions known to promote obesity in the participating child (e.g. Prader-Willi).
- Diagnosed eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) in either parent (participating and nonparticipating) and/or the participating child.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Peer Interventionist
Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by parents who previously received this treatment (PEER).
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
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This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
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활성 비교기: Professional Interventionist
Families randomized to this family-based behavioral intervention arm will receive 20 weeks of family-based behavioral pediatric overweight intervention delivered by behavioral specialists(PROFESSIONAL).
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
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This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Child BMI z-score
기간: 20 weeks
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20 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptability
기간: 20 weeks
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Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision
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20 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Brian E. Saelens, PhD, Seattle Children's
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 (추정)
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. .