THRIVE 2.0: A randomized-controlled trial of an obesity prevention intervention designed for infants in pediatric primary care

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-04-21 DOI:10.1016/j.conctc.2025.101488

Tiffany M. Rybak , Sarah E. Francis , Constance A. Mara , Cynthia Zion , Avani C. Modi , Lori E. Crosby , Rachel B. Herbst , Brea A. Lauer , Bridget N. Murphy , Kasey R. Harry , Devanshi J. Patel , Mary Carol Burkhardt

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引用次数: 0

Abstract

Background

Unprecedented rates of overweight and obesity are seen in childhood with evidence suggesting that infancy may be a critical period for the development of this elevated-weight trajectory. The impact of rapid growth in infancy on later obesity may differ by social stratification factors such as race/ethnicity and family income and be mediated by infant feeding and sleeping practices. This paper outlines the protocol for the Teaching Healthy Responsive Parenting during Infancy to promote Vital growth and rEgulation (THRIVE 2.0) intervention.

Methods/design

This Phase 2b pilot randomized controlled trial will determine the feasibility, acceptability, satisfaction, and preliminary efficacy of the THRIVE 2.0 intervention compared with primary care treatment as usual (control). Caregiver-infant dyads will be recruited in pediatric primary care at their newborn visit and randomly assigned to THRIVE 2.0 (obesity prevention) or Control (usual pediatric care). Feasibility, acceptability, satisfaction, infant growth, feeding, and sleep will be assessed throughout the study period. Intervention will take place at regularly scheduled well-child visits at ages 1, 2, 4, and 6 months. Efficacy measures will be assessed at baseline, and 9 and 12 months of age. THRIVE is hypothesized to demonstrate efficacy for primary (e.g., conditional weight gain scores calculated from weight-for-length z-scores) and secondary outcomes (e.g., awareness of infant cues, use of alternative soothing strategies when it is not time for a feeding, and good infant sleep hygiene).

Discussion

This paper outlines the planned procedures for the THRIVE 2.0 Phase 2b randomized controlled trial.

Trial registration

Clinicaltrials.gov Identifier: NCT06028113 (October 10, 2023)

查看原文本刊更多论文

THRIVE 2.0：一项针对儿科初级保健婴儿肥胖预防干预设计的随机对照试验

儿童时期超重和肥胖的比例是前所未有的，有证据表明婴儿期可能是这种体重增加轨迹发展的关键时期。婴儿期快速增长对后期肥胖的影响可能因种族/民族和家庭收入等社会分层因素而异，并受婴儿喂养和睡眠习惯的调节。本文概述了在婴儿期进行健康反应性养育以促进生命生长和调节（THRIVE 2.0）干预的方案。方法/设计：本2b期随机对照试验将确定THRIVE 2.0干预与常规初级保健治疗（对照）相比的可行性、可接受性、满意度和初步疗效。在新生儿就诊时，将在儿科初级保健中招募照顾者-婴儿对，并随机分配到THRIVE 2.0（肥胖预防）或控制（常规儿科护理）组。可行性、可接受性、满意度、婴儿生长、喂养和睡眠将在整个研究期间进行评估。干预将在1、2、4和6个月大时定期进行。将在基线、9个月和12个月时评估疗效措施。THRIVE被假设为主要（例如，根据体重长度z分数计算的条件体重增加分数）和次要结果（例如，对婴儿线索的意识，在非喂养时间使用替代安抚策略，以及良好的婴儿睡眠卫生）的有效性。本文概述了THRIVE 2.0期2b期随机对照试验的计划程序。临床试验。gov标识符：NCT06028113（2023年10月10日）

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.