Foundations of Fitness Program Pilot
2019년 7월 8일 업데이트: Auden McClure, Dartmouth-Hitchcock Medical Center
Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer.
Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this.
Clinical-community partnerships are well-positioned to address this care gap.
This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting.
In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic.
Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase.
The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change.
A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.
연구 개요
연구 유형
중재적
등록 (실제)
29
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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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Dartmouth-Hitchcock Medical Center
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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:
- Age 7-13 years;
- BMI% ≥85th%;
- Regional pediatric medical home patient;
- English speaking child and parent/caregiver;
Exclusion Criteria:
- Physical or developmental limitation to participation as determined by referring provider
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: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 7-10 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
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The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review.
Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families.
Content will be offered in a context that supports self-esteem and behavior change.
The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
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실험적: 11-13 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
|
The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review.
Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families.
Content will be offered in a context that supports self-esteem and behavior change.
The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
기간: 24 weeks
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Programmatic feasibility will be defined as delivery of 100% of the sessions with 80% of children attending ≥75% of sessions and 80% completing pre- and post-assessments.
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24 weeks
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Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
기간: 24 weeks
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Program acceptability will be assessed through semi-structured participant interviews ensuring the appropriateness of the pilot and assessing strengths/weaknesses.
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24 weeks
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Program Eligibility rate
기간: 24 weeks
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Calculated using the following formula: [# screen positive / # screened for inclusion].
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24 weeks
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Program Enrollment rate
기간: 24 weeks
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Calculated using the following formula: [# enrolled / (# screen positive & eligible)].
We will assess reasons for dropout/non-adherence.
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24 weeks
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Program Completion rate
기간: 24 weeks
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Calculated using the following formula: (# completing all sessions / # enrolled).
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24 weeks
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Assessment Completion rate
기간: 24 weeks
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Calculated using the following formula: (# completing all assessments / # enrolled).
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24 weeks
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Participant Satisfaction Survey
기간: 24 weeks
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A 12 item survey at program conclusion will assess patient satisfaction with program elements (overall, class sessions, staff, assessments) using Likert scales (1-5 point scale - very dissatisfied=1 to very satisfied=5).
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24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body Mass Index Percentile
기간: 48 weeks
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Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2) and then BMI percentile (%) using Center for Disease Control 2000 standards.
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48 weeks
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Strength Assessment
기간: 24 weeks
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Assessed through 5 exercises including: leg extension, leg curl, lap pull down, shoulder press, chest press.
Units for all are number of repetitions per minute at a fixed mass (lbs).
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24 weeks
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Health Habits Survey
기간: 24 weeks
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The Weight & Wellness Center Health Habits Survey assesses diet, activity, media and sleep behaviors through 46 individual survey questions with variable response categories (for example, overall physical activity is assessed using a 0-5 point Likert scale with higher score related to better physical activity level: " Overall my physical activity level is": Poor=0 - Excellent=5)
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24 weeks
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Subjective Health and Quality of Life Score
기간: 24 weeks
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The Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health 7 survey (child and parent proxy) is a 7-question survey (Score 7-35) capturing physical, mental, and social aspects of quality of life using Likert scales (1-5 point scale: poor/never=1 to excellent/always=5). Higher score indicates more positive perceptions of overall health.
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24 weeks
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Sense of Belonging in Fitness Program Score
기간: 24 weeks
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The Anderson-Butcher and Conroy Sense of Belonging survey is a 5-item questionnaire measuring sense of belonging experienced by children participating in a Fitness Program using Likert scale (1-4 point scale: NO!=1, no=2, yes=3, and YES!=4).
Total Score Range 5-20: A higher score indicates a greater sense of belonging.
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24 weeks
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Self Esteem Score
기간: 24 weeks
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The Rosenberg Self-Esteem survey is a 10-item questionnaire measuring self-esteem of children participating in a Fitness Program using Likert scale (0-3 point scale: Strongly disagree=0 to Strongly agree=3).
Total Score Range 0-30: Higher scores indicate greater self-esteem.
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24 weeks
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Physical Activity Score
기간: 24 weeks
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The Patient Reported Outcomes Measurement Information Systems (PROMIS) is a short form 4-question survey (Score 4-20) assessing physical activity over the past seven days using Likert scales (1-5 point scale: No days=1, 1 day=2, 2-3 days=3, 4-5 days=4, and 6-7 days=5).
Higher score indicates higher levels of physical activity.
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24 weeks
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Cardio-capacity
기간: 24 weeks
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Distance (m) on treadmill at 65% of max heart rate.
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24 weeks
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Heart Rate
기간: 24 weeks
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Resting and recovery heart rate (BPM) measured before and after treadmill test.
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24 weeks
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Blood Pressure
기간: 24 weeks
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Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
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24 weeks
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Waist Circumference
기간: 24 weeks
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Waist circumference will be measured (cm)
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24 weeks
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Perceived Athletic Competence Score
기간: 24 weeks
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The Harter Self-Perception Profile for Children is a short form 6-question survey (score 1-4) assessing athletic competence using a two-choice format with option then of checking "Sort of True for Me" or "Really True for Me" (A score of 1 indicates lowest and a score of 4 highest level of perceived athletic competence).
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24 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Staff program adoption
기간: 24 weeks
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Staff program adoption will be assessed using semi-structured interviews assessing staff experience with workflow and adoption of Foundations of Fitness Program.
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24 weeks
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Fidelity to planned program
기간: 24 weeks
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We will assess percent of planned class sessions and planned outcome assessments that were administered.
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24 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Auden C McClure, MD MPH, Dartmouth-Hitchcock Medical Center
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 (실제)
2018년 7월 12일
기본 완료 (실제)
2019년 6월 12일
연구 완료 (실제)
2019년 6월 12일
연구 등록 날짜
최초 제출
2018년 7월 18일
QC 기준을 충족하는 최초 제출
2018년 8월 7일
처음 게시됨 (실제)
2018년 8월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 7월 8일
마지막으로 확인됨
2019년 7월 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. .