Supporting Together Exercise and Play and Improving Nutrition (STEP IN)
2020년 11월 13일 업데이트: Children's Hospital Medical Center, Cincinnati
Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.
연구 개요
상세 설명
In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity.
The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time
연구 유형
중재적
등록 (실제)
36
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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Ohio
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Cincinnati, Ohio, 미국, 45229
- Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital 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
6년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)
- BMI is greater than 85th%ile for age and sex
- English speaking
- have access to a computer/internet or a smart phone (for uploading Fitbit data)
Exclusion Criteria:
- Have been seen in a weight management clinic within the last 2 years
- prescribed an atypical antipsychotic
- non-ambulatory
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: Biweekly Arm
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place biweekly.
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The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
다른 이름들:
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
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실험적: Monthly Arm
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place monthly.
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The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
다른 이름들:
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
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실험적: Weekly
6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session.
Sessions took place weekly.
|
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session.
Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson.
Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
다른 이름들:
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session.
This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Attendance
기간: Baseline, 3 months
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Evaluation of participant attendance in each arm.
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Baseline, 3 months
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Overall Satisfaction With Group Nutrition Sessions
기간: Baseline, 3 months
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Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
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Baseline, 3 months
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Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
기간: Baseline, 3 months
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Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases.
Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
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Baseline, 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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PedsQL (Pediatric Quality of Life Inventory)
기간: Baseline, 3 months
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Measure Description: PedsQL (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related Quality of Life.
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Baseline, 3 months
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BMI Z-Score
기간: Baseline, 3 months
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BMI Z-scores compares child to age and sex matched peers.
A z-score of 0 is the same as a 50th percentile in the reference population, a z-score of ± 1.0 plots at the 15th or 85th percentiles, respectively, and a z-score of ± 2 plots at roughly the 3rd or 97th percentiles.
Negative numbers indicate values lower than the reference population whereas positive numbers indicate values higher than the reference population.
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Baseline, 3 months
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Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
기간: baseline, 3 months
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The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
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baseline, 3 months
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Child Self-efficacy Related to Physical Activity
기간: Baseline, 3 months
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Self efficacy was assessed using a validated 14-item questionnaire using a 5-point Strongly Agree/ Strongly Disagree scale.
The range of values is 1 to 5, with lower values indicating higher self-efficacy
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Baseline, 3 months
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Child Intention to be Active
기간: baseline, 3 months
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Child intention to be active was assessed with a 1-item questionnaire developed and validated by Saunders et al.
This item uses a 5-point scale, with possible range of scores being 1 to 5. Higher scores indicate greater intention to be active.
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baseline, 3 months
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Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
기간: Baseline, 3 months
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Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases.
Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
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Baseline, 3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kristen A Copeland, Children's Hospital Medical Center, Cincinnati
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
2015년 6월 1일
기본 완료 (실제)
2018년 10월 1일
연구 완료 (실제)
2018년 12월 1일
연구 등록 날짜
최초 제출
2016년 3월 14일
QC 기준을 충족하는 최초 제출
2016년 3월 25일
처음 게시됨 (추정)
2016년 3월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 11월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 11월 13일
마지막으로 확인됨
2019년 1월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
IPD 계획 설명
This was a small, iterative feasibility study as a precursor to a larger clinical trial.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
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. .