农村妊娠期糖尿病妇女参与的糖尿病预防 Camp 式生活方式改良方案（CAMP）：一项三臂簇集型 2 型随机对照试验的研究方案。

Camp-style lifestyle modification program (CAMP) for diabetes prevention among rural women with prior GDM: study protocol for a three-arm cluster hybrid type 2 randomized controlled trial.

机构信息

Xiangya School of Nursing, Central South University, 172 Tongzipo Road, Changsha, Hunan, 410013, China.

Manchester Centre for Health Psychology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, M13 9PL, UK.

出版信息

BMC Public Health. 2024 Sep 20;24(1):2570. doi: 10.1186/s12889-024-20080-0.

DOI:10.1186/s12889-024-20080-0

PMID:39304869

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11414119/

Abstract

BACKGROUND

Intensive lifestyle interventions were effective to reduce the risk of type 2 diabetes mellitus (T2DM) for women with gestational diabetes mellitus (GDM) history. However, reaching these mothers and maintaining participation in lifestyle interventions is suboptimal in real-world settings. Effective, feasible and sustainable new lifestyle interventions are needed. The objectives of this three-arm trial are to (1) compare diabetes risk outcomes of an evidence-based intensive lifestyle modification (ILSM) intervention, a camp-style lifestyle modification program (CAMP) intervention, and usual care among women with GDM history; and (2) evaluate the comparative efficacy of the CAMP versus ILSM intervention on implementation outcomes.

METHODS

A three-arm cluster randomized clinical trial (RCT) using a hybrid type 2 implementation design will be conducted in two counties in Hunan province in China. Six towns from each county will be randomly selected and assigned to CAMP, ILSM, and the usual care group (25 women from each of 12 towns, 100 women in each arm). The ILSM includes six biweekly in-person sessions and 3-month telephone health consultations, while the CAMP consists of a 2-day camp-based session and 3-month health consultations via a popular social media platform. Both interventions share the same session content, including six lifestyle skills. Efficacy (T2DM risk score and behavioral, anthropometric, psychosocial, and glycemic variables) and implementation outcomes (recruitment, acceptability, feasibility, fidelity, and cost-effectiveness) will be collected at baseline, 6-month, and 12-month. Pre-planned ANOVA F-test and generalized estimating equations will be included to test time-by-arm interactions.

DISCUSSION

The CAMP intervention is expected to have better reach, better attendance, and comparable effectiveness in reducing the risk of T2DM, thus improving postpartum care for GDM in China. The delivery of a concentrated format supplemented with technology-based support may provide an efficient and effective delivery model for implementing maternal health promotion programs in primary care settings.

TRIAL REGISTRATION

Registered in the Chinese Clinical Trial Registry (ChiCTR2200058150) on 31st March 2022.

摘要

背景

强化生活方式干预可有效降低有妊娠糖尿病史的女性患 2 型糖尿病（T2DM）的风险。然而，在实际环境中，这些母亲的干预参与度和维持率并不理想。因此，需要寻找有效、可行且可持续的新的生活方式干预措施。本三臂试验的目的是：（1）比较有妊娠糖尿病史的女性中，基于证据的强化生活方式干预（ILSM）、营地式生活方式干预（CAMP）与常规护理的糖尿病风险结局；（2）评估 CAMP 与 ILSM 干预在实施结局方面的比较效果。

方法

本研究采用混合 2 型实施设计的三臂聚类随机临床试验（RCT），在中国湖南省的两个县进行。每个县随机选择 6 个乡镇，并将其分配到 CAMP、ILSM 和常规护理组（每个乡镇 25 名女性，每个组 100 名女性）。ILSM 包括 6 次每两周一次的面对面课程和 3 个月的电话健康咨询，而 CAMP 则由为期 2 天的营地课程和通过流行社交媒体平台进行的 3 个月健康咨询组成。两种干预措施的课程内容相同，包括 6 项生活技能。在基线、6 个月和 12 个月时，将收集疗效（T2DM 风险评分以及行为、人体测量学、心理社会和血糖变量）和实施结局（招募、可接受性、可行性、一致性和成本效益）。