- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00759746
Childhood Obesity Treatment: A Maintenance Approach (COMPASS)
2017년 2월 20일 업데이트: Washington University School of Medicine
The purpose of this study is to determine the effect of dose and content of an enhanced weight maintenance treatment on children's ability to maintain weight loss following a standard weight loss treatment.
연구 개요
상태
완전한
상세 설명
Childhood Obesity (CO) prevalence in the United States has tripled in recent decades, and nearly 30% of children aged 6 to 11 are overweight or obese.
CO is a serious public health problem, and is associated with both immediate and long-term health problems (e.g., hypertension, type 2 diabetes, asthma) and psychosocial problems (e.g., social isolation, depression, eating disorder symptomatology).
Furthermore, CO is a significant risk factor for adult obesity with several prospective studies showing that, if untreated, about half of overweight grade-school children remain obese as adults.
Fortunately, children respond favorably to family-based behavioral weight loss treatment (FBT), the most well-established intervention for the treatment of overweight in children 7 to 12 years old.
Weight loss treatments for overweight children have been associated with significant physical and psychosocial health benefits; however, despite initial success with lifestyle interventions, considerable relapse often occurs once treatment ends.
Clearly, CO is a significant public health problem, and long-term maintenance of weight loss remains a priority to stem the increased costs to the individual and society.
Therefore, we propose to conduct a multi-site randomized controlled trial with overweight children (N=241) and their parents (N=241) [for a total N=482].
All participants will complete 4 months of FBT and then be randomized to one of three, 8-month maintenance conditions: (1) Weight Maintenance Therapy, who will receive SFM - Low Dose [LOW] (16 sessions over 8 months), (2) Intensive Weight Maintenance Therapy, who will receive SFM - High Dose [HIGH] (32 sessions over 8 months), or (3) Current Standard of Care, who will receive Weight Maintenance Education (16 sessions over 8 months).
Relative weight and associated outcomes will be assessed at 0 (pre-weight loss), 4 (post-weight loss), 12 (post-maintenance treatment),18 months and 24 months.
Additionally, brief assessments will be conducted at four points during the course of maintenance treatment to measure presumed mediators.
연구 유형
중재적
등록 (실제)
482
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Missouri
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St. Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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Washington
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Seattle, Washington, 미국, 98121
- Seattle Children's Hospital Research Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
7년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Children will be between the ages of 7 and 11 and at or above the 85th percentile for weight.
- At least one parent of the participating child must be overweight (BMI ≥ 25).
- One parent must agree to attend all parent/child treatment meetings as the participating parent.
- Participants must be able to speak and comprehend English.
Exclusion Criteria:
- Participating parent or child having a thought disorder, suicidality, bipolar disorder, or drug or alcohol dependence.
- Participating parent or child having a physical disability or illness that prevents performance of physical activity at level equivalent to a brisk walk or that places severe restriction on diet.
- Participating parent or child being on a medication regimen that affects weight.
- Participating parent or child being involved in active psychiatric treatment for an ongoing problem that causes either social or occupational impairment.
- Parents (participating and nonparticipating) and children having an eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) or having subclinical levels of eating disturbance (i.e., reporting key eating disorder behaviors of purging, fasting, or binge eating more than two times per month).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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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활성 비교기: Weight Maintenance Education
Participants assigned to this group will receive the Weight Maintenance Education intervention.
They will meet every other week during the maintenance phase of the study for a total of 16 sessions over 8 months.
During the visit, participants will participate in a series of interactive workshops within child and parent groups to learn general information about healthy eating and physical activity.
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The Weight Maintenance Education intervention will help participants in parent and child groups to learn more about healthy eating and physical activity in a group setting.
Participants will also learn about exercise and exercise safety, hydration during exercise, and stress management.
Parent and child groups will combine for particular on-site and off-site activities, such as cooking demonstrations, grocery store tours, gym tours, and dance lessons.
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실험적: SFM+ Low Dose
Participants assigned to this group will receive the SFM+ Low Dose.
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The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance.
Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers).
Participants in this group will meet less often than families that receive the Social Facilitation Maintenance (SFM) - High Dose intervention, giving them more opportunities to practice new skills between clinic visits.
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실험적: SFM+ High Dose
Participants assigned to this group will receive the SFM+ High Dose.
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The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance.
Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers).
Participants in this group will meet more often than families that receive the Social Facilitation Maintenance (SFM) - Low Dose intervention, allowing for more in-depth discussion and practice of key skills and concepts related to creating a social environment that supports a healthy lifestyle.
These participants will receive more feedback and reinforcement from fellow group members, family interventionists, and group leaders for practicing their new behaviors.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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아동 과체중
기간: 일년
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일년
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Brian Saelens, Ph.D., Seattle Children's Hospital Research Institute
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Hayes JF, Altman M, Kolko RP, Balantekin KN, Holland JC, Stein RI, Saelens BE, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Decreasing food fussiness in children with obesity leads to greater weight loss in family-based treatment. Obesity (Silver Spring). 2016 Oct;24(10):2158-63. doi: 10.1002/oby.21622. Epub 2016 Sep 7.
- Altman M, Cahill Holland J, Lundeen D, Kolko RP, Stein RI, Saelens BE, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Reduction in food away from home is associated with improved child relative weight and body composition outcomes and this relation is mediated by changes in diet quality. J Acad Nutr Diet. 2015 Sep;115(9):1400-7. doi: 10.1016/j.jand.2015.03.009. Epub 2015 May 8.
- Holland JC, Kolko RP, Stein RI, Welch RR, Perri MG, Schechtman KB, Saelens BE, Epstein LH, Wilfley DE. Modifications in parent feeding practices and child diet during family-based behavioral treatment improve child zBMI. Obesity (Silver Spring). 2014 May;22(5):E119-26. doi: 10.1002/oby.20708. Epub 2014 Mar 25.
- Best JR, Theim KR, Gredysa DM, Stein RI, Welch RR, Saelens BE, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Behavioral economic predictors of overweight children's weight loss. J Consult Clin Psychol. 2012 Dec;80(6):1086-1096. doi: 10.1037/a0029827. Epub 2012 Aug 27.
- Fowler LA, Litt MD, Rotman SA, Conlon RPK, Jakubiak J, Stein RI, Balantekin KN, Welch RR, Perri MG, Epstein LH, Wilfley DE. Relation of social network support to child health behaviors among children in treatment for overweight/obesity. Eat Weight Disord. 2022 Jun;27(5):1669-1678. doi: 10.1007/s40519-021-01303-4. Epub 2021 Sep 21.
- Grammer AC, Best JR, Fowler LA, Balantekin KN, Stein RI, Conlon RPK, Saelens BE, Welch RR, Perri MG, Epstein LH, Wilfley DE. General and Eating Disorder Psychopathology in Relation to Short- and Long-Term Weight Change in Treatment-Seeking Children: A Latent Profile Analysis. Ann Behav Med. 2021 Jun 28;55(7):698-704. doi: 10.1093/abm/kaaa076.
- Fowler LA, Grammer AC, Ray MK, Balantekin KN, Stein RI, Kolko Conlon RP, Welch RR, Perri MG, Epstein LH, Wilfley DE. Examining the interdependence of parent-child dyads: Effects on weight loss and maintenance. Pediatr Obes. 2021 Jan;16(1):e12697. doi: 10.1111/ijpo.12697. Epub 2020 Jul 28.
- Rotman SA, Fowler LA, Ray MK, Stein RI, Hayes JF, Kolko RP, Balantekin KN, Engel A, Saelens BE, Welch RR, Perri MG, Epstein LH, Wilfley DE. Family Encouragement of Healthy Eating Predicts Child Dietary Intake and Weight Loss in Family-Based Behavioral Weight-Loss Treatment. Child Obes. 2020 Apr;16(3):218-225. doi: 10.1089/chi.2019.0119. Epub 2019 Dec 12.
- Wilfley DE, Saelens BE, Stein RI, Best JR, Kolko RP, Schechtman KB, Wallendorf M, Welch RR, Perri MG, Epstein LH. Dose, Content, and Mediators of Family-Based Treatment for Childhood Obesity: A Multisite Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1151-1159. doi: 10.1001/jamapediatrics.2017.2960.
- Balantekin KN, Hayes JF, Sheinbein DH, Kolko RP, Stein RI, Saelens BE, Hurst KT, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Patterns of Eating Disorder Pathology are Associated with Weight Change in Family-Based Behavioral Obesity Treatment. Obesity (Silver Spring). 2017 Dec;25(12):2115-2122. doi: 10.1002/oby.22028. Epub 2017 Oct 6.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 10월 1일
기본 완료 (실제)
2013년 3월 1일
연구 완료 (실제)
2013년 3월 1일
연구 등록 날짜
최초 제출
2008년 9월 23일
QC 기준을 충족하는 최초 제출
2008년 9월 24일
처음 게시됨 (추정)
2008년 9월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 2월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 2월 20일
마지막으로 확인됨
2017년 2월 1일
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. .
Weight Maintenance Education에 대한 임상 시험
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University of North Carolina, Chapel HillWeight Watchers International완전한
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Medical University of South CarolinaWeight Watchers International완전한
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The Miriam HospitalUniversity of Tennessee; Weight Watchers International완전한
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne모집하지 않고 적극적으로
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University of OxfordBeijing Normal University; Beijing Stars and Rain Education Institute for Autism완전한아동 학대 | 부모-자녀 관계 | 자폐 스펙트럼 장애 | 육아 | 아동 행동 문제 | 가족 관계 | 정신 건강 문제중국