Should pregnant women be excluded from a community-based lifestyle intervention trial? A case study

被引:0
作者
Mathews, Elezebeth [1 ]
机构
[1] Cent Univ Kerala, Dept Publ Hlth & Community Med, Kasaragod, Kerala, India
基金
英国惠康基金;
关键词
Fair inclusion; Lifestyle modification; Type 2 diabetes mellitus; Ethics; Pregnancy research; Clinical translational research; GESTATIONAL DIABETES-MELLITUS; RISK; PREVENTION; PREVALENCE;
D O I
10.1186/s12978-017-0422-2
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Kerala, the southernmost Indian state, is known as the diabetes capital of the country. A community-based lifestyle modification program was implemented in the rural areas of Kerala, India, to assess effectiveness in reducing the incidence of type 2 diabetes mellitus (T2DM) among individuals at high risk. High-risk individuals for T2DM were identified through home screening and enrolled into the program after an oral glucose tolerance test to rule out T2DM. Pregnant women were excluded from participation in the trial without justification. An analysis is offered to show that exclusion in this case compromised the ethical requirements of fairness and favorable risk-benefit ratio: specifically, pregnant women were deprived of the benefits of screening for high-risk status and subsequent potential involvement in the lifestyle modification intervention, an effective preventive strategy. Exclusion of pregnant women from translational and implementation research with known benefits over risk violates several ethical principles and further limits the exploration and advancement of research for future disease prevention in the population at large. Clearer guidelines on minimal risk and benefit need to be established in order to facilitate research that is beneficial to pregnant women and the developing fetus.
引用
收藏
页数:4
相关论文
共 50 条
  • [21] Effects of lifestyle intervention improve cardiovascular disease risk factors in community-based menopausal transition and early postmenopausal women in China
    Wu, Liping
    Chen, Rong
    Ma, Di
    Zhang, Sijia
    Walton-Moss, Benita
    He, Zhong
    MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY, 2014, 21 (12): : 1263 - 1268
  • [22] Factors associated with food consumption score among pregnant women in Eastern Ethiopia: a community-based study
    Meseret Belete Fite
    Abera Kenay Tura
    Tesfaye Assebe Yadeta
    Lemessa Oljira
    Kedir Teji Roba
    Journal of Health, Population and Nutrition, 41
  • [23] Factors associated with food consumption score among pregnant women in Eastern Ethiopia: a community-based study
    Fite, Meseret Belete
    Tura, Abera Kenay
    Yadeta, Tesfaye Assebe
    Oljira, Lemessa
    Roba, Kedir Teji
    JOURNAL OF HEALTH POPULATION AND NUTRITION, 2022, 41 (01)
  • [24] Effects of a Multidomain Lifestyle Modification on Cognitive Function in Older Adults: An Eighteen-Month Community-Based Cluster Randomized Controlled Trial
    Lee, Kang Soo
    Lee, Yunhwan
    Back, Joung Hwan
    Son, Sang Joon
    Choi, Seong Hye
    Chung, Young-Ki
    Lim, Ki-Young
    Noh, Jai Sung
    Koh, Sang Hyun
    Oh, Byoung Hoon
    Hong, Chang Hyung
    PSYCHOTHERAPY AND PSYCHOSOMATICS, 2014, 83 (05) : 270 - 278
  • [25] Effect of healthy lifestyle index and lifestyle patterns on the risk of mortality: A community-based cohort study
    Hu, Peng
    Zheng, Murui
    Huang, Jun
    Fan, Huan-Ying
    Fan, Chun-Jiang
    Ruan, Hui-Hong
    Yuan, Yue-Shuang
    Zhao, Wenjing
    Wang, Harry H. X.
    Deng, Hai
    Liu, Xudong
    FRONTIERS IN MEDICINE, 2022, 9
  • [26] The impact of a culturally adapted lifestyle intervention on the glycaemic profile of mothers with GDM one year after delivery - a community-based, cluster randomized trial in Sri Lanka
    Sundarapperuma, Thamudi D.
    Katulanda, Prasad
    Wijesinghe, Champa J.
    Hettiarachchi, Priyadarshika
    Wasalathanthri, Sudharshani
    BMC ENDOCRINE DISORDERS, 2024, 24 (01)
  • [27] Community-based non-pharmacological interventions for pregnant women with gestational diabetes mellitus: a systematic review
    Igwesi-Chidobe, Chinonso Nwamaka
    Okechi, Peace Chioma
    Emmanuel, Grace Nneoma
    Ozumba, Benjamin C.
    BMC WOMENS HEALTH, 2022, 22 (01)
  • [28] Lifestyle and Care Indicators in Individuals with Major, Minor and No Depression: A Community-Based Diabetes Study in Quebec
    Messier, Lyne
    Schmitz, Norbert
    Elisha, Belinda
    Gariepy, Genevieve
    Malla, Ashok
    Lesage, Alain
    Boyer, Richard
    Wang, Jian Li
    Strychar, Irene
    CANADIAN JOURNAL OF DIABETES, 2011, 35 (01) : 22 - 30
  • [29] Associations of lifestyle activities and a heathy diet with frailty in old age: a community-based study in Singapore
    Wang, Xiu
    Lu, Yanxia
    Li, Chunbo
    Larbi, Anis
    Feng, Liang
    Shen, Qingfeng
    Chong, Mei Sian
    Lim, Wee Shiong
    Feng, Lei
    AGING-US, 2020, 12 (01): : 288 - 308
  • [30] The Effect of Community-Based Education for Lifestyle Intervention on the Prevalence of Metabolic Syndrome and Its Components: Tehran Lipid and Glucose Study
    Azizi, Fereidoun
    Mirmiran, Parvin
    Momenan, Amir Abbas
    Hadaegh, Farzad
    Moeini, Ali Habibi
    Hosseini, Firoozeh
    Zahediasl, Saleh
    Ghanbarian, Arash
    Hosseinpanah, Farhad
    INTERNATIONAL JOURNAL OF ENDOCRINOLOGY AND METABOLISM, 2013, 11 (03) : 145 - 153