Strong Futures: A Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
2021년 11월 15일 업데이트: University of California, San Francisco
Strong Futures: A Pilot Randomized Controlled Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
Latino children experience higher rates of obesity compared to non-Hispanic white children, especially in low-income communities.
Optimal feeding strategies in early life, avoidance of screen time and longer sleep duration may lower the risk of obesity.
Family financial hardship is also associated with short- and long-term health risks, including behavioral and mental health problems, and toxic stress which contributes to elevated risk of common chronic conditions over the life course.
This proposal aims to pilot test two interventions to promote optimal health outcomes in Latino infants.
Study participants will meet with a health educator after well child visits at 2-weeks, 2-, 4-, 6-, 9- and 12-months.
Half of the parents will receive education on obesity prevention.
The other half will receive financial education and case management using an established financial coaching approach.
Parents will also receive text messages that reinforce educational content.
The objective of this study is to determine the acceptability and feasibility of offering these interventions in the well-child setting.
Study investigators also seek to determine the preliminary efficacy of these interventions on infant and parent health outcomes including dietary intake, screen time, sleep duration, health related quality of life and financial stress.
연구 개요
연구 유형
중재적
등록 (실제)
194
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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California
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San Francisco, California, 미국, 94110
- Children's Health Center at San Francisco General Hospital
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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
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Study investigators will recruit parents who self-identify as Latino and their newborn infants
- Infants must be born at Zuckerberg San Francisco General Hospital (ZSFG)
- Infants must be singletons
- Parents must intend to receive primary care for their infant at Zuckerberg San Francisco General Hospital
- Parents must speak Spanish (but may also speak English)
Exclusion Criteria:
- Infants with birth weights less than 2500 grams
- Infants born prior to 37 weeks and 0 days gestation
- Infants with any medical condition that significantly affects feeding, such as infants who are unable to feed by mouth
- Infants with any medical condition that is known to be associated with failure to thrive or specialized nutritional needs
- Infants in foster care
- Infants for whom the primary caregiver is not the infant's mother or father
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Infant Obesity Prevention
The infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.
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Parents will receive education on infant feeding, sleep, and screen time practices just after well-child visits in the first year of life.
The education will be provided by a lay health educator.
Parents will also receive text messages to reinforce the intervention content
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실험적: Financial Coaching
The financial coaching arm will provide parents with education on basic financial literacy topics and coaching to help parents achieve financial goals.
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Parents randomized to the financial coaching arm will receive basic education on financial topics including budgeting, savings, and managing debt as well as coaching on these topics just after well-child visits in the first year of life.
Coaching will be provided by lay health educators trained in financial coaching.
Parents will also receive text messages reinforcing the information learned.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Child dietary intake
기간: 15-months
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Total child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.
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15-months
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Child screen time
기간: Child age 15-months
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Total minutes of daily screen time
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Child age 15-months
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Parent health-related quality of life
기간: Child age 15-months
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Assessed by the PROMIS-10.
The Patient Reported Outcome Measurement Information System Global Short Form 10 (PROMIS-10) is a ten-item scale measuring health related quality of life with subscales for physical and mental health.
Raw overall total PROMIS-10 scale scores range from 10-50, with sub-scale T-scores that range from 16-67 for physical health and 21-68 for mental health.
For all PROMIS-10 total raw and sub-scale scores, higher scores indicate better health-related quality of life.
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Child age 15-months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Child anthropometrics
기간: Child ages 6-months, 12-months, 15-months and 24-months
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World Health Organization Weight-for-length z-score
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Child ages 6-months, 12-months, 15-months and 24-months
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Parent financial stress
기간: Child age 15-months
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Consumer Financial Protection Bureau Financial Well-Being Scale.
The Consumer Financial Protection Bureau Financial Well Being Questionnaire (Short Form, CFPB Financial Well Being Questionnaire SF) is a five item scale measuring individual financial well-being.
The CFPB Financial Well Being Questionnaire has a range of 0-20 raw score, based on a 5-point Likert scale for each item, with one item (item 4) reverse coded and summed with responses for the remaining items to arrive at the raw score.
The raw score is converted to a reference financial well-being score.Higher scores indicate greater financial well-being.
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Child age 15-months
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Child sleep
기간: Child age 15-months
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Child total minutes of sleep in 24-hour period
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Child age 15-months
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Parental feeding styles
기간: 15-months
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Study investigators will assess responsive, pressuring and indulgent feeding styles using the "responsive satiety," "pressuring finishing," "pressuring soothing," and "indulgence permissive" sub-scales of the Infant Feeding Styles Questionnaire.
These sub-scales assess both behaviors and beliefs relevant to the construct.
Scores range from 1-5 with higher scores indicating greater use of that feeding style.
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15-months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Amy L Beck, MD, MPH, University of California, San Francisco
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 4월 11일
기본 완료 (실제)
2021년 4월 30일
연구 완료 (실제)
2021년 4월 30일
연구 등록 날짜
최초 제출
2018년 1월 23일
QC 기준을 충족하는 최초 제출
2018년 2월 16일
처음 게시됨 (실제)
2018년 2월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 11월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 11월 15일
마지막으로 확인됨
2021년 11월 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. .
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