Cases in Bioethics: Health Research Ethics in Southeast Asia
Keywords

stigma, vulnerable population, obesity, educational intervention, children; school-based study

The prevalence of being overweight or obese among children and adolescents has increased globally between 1980 and 2013; from 8.1% to 12.9% in girls and 8.4% to 13.4% in boys.1 Increased body mass index (BMI) early in life predisposes individuals to metabolic syndrome, type 2 diabetes mellitus, polycystic ovarian disease, hypertension, dyslipidemia, and coronary heart disease in adulthood.2 Factors attributed to this rise in BMI in children within many low and middle income countries include lack of physical activity, excessive calorie intake, urbanization, and a shift from low to high socioeconomic status.3

A recent survey in a city in Southeast Asia showed a high prevalence of childhood obesity. The local health department proposed a government-sponsored project to design, implement, and assess the effectiveness of an 18-month weight reduction program for children in schools. Researchers from leading medical institutions were invited to develop the intervention and plan the study. The intervention consisted of learning modules for children based on physical exercise and healthy dietary habits that could be easily introduced into daily life. Each module was a 30-minute weekly session, offered over a period of 6 months. The researchers recruited 2,000 children 11 to 17 years old who met specific weight criteria4 who attended one of four city schools. The researchers obtained parental permission/consent and assent from eligible children. The proposal was approved by a research ethics committee (REC), given the potential for direct benefits to student participants.

Children enrolled in the study received the study intervention during physical education class, while their peers who were not overweight/obese attended the typical class. Children who participated in the study were stigmatized by their peers based on their weight status, and parents of a participant complained to the school that their child refused to attend school because they were being made fun of about body image and because they were enrolled in the weight reduction study. School staff and the research team provided reassurance to this student but continued the study. Study data were recorded using a software application designed for the study.

After observing a reduction in BMI scores measured at end of the study compared to baseline measurements, the researchers concluded that the weight-loss intervention was effective. They sent a report and individual participant data to the school to update the children’s health records and also submitted a detailed study report to the local health department, including raw data along with before-and-after photographs of the children.

Questions

  1. What strategies could the researchers have used to avoid stigmatization of the study participants?

  2. Would it have been better to hold training sessions outside of school hours, such as during the weekend?

  3. What are appropriate strategies for seeking assent and consent for research involving the assessment of height and weight in children?

  4. What safeguards should be in place for sharing study records about individual participants, including the photographs taken pre- and postintervention?

  5. Who is responsible for monitoring the implementation of the study intervention to ensure any concerns are identified and addressed?

References

Gupta, Nidhi, Priyali Shah, Sugandha Nayyar, and Anoop Misra. “Childhood Obesity and the Metabolic Syndrome in Developing Countries.” The Indian Journal of Pediatrics 80, no. S1 (January 20, 2013): 28–37. https://doi.org/10.1007/s12098-012-0923-5.
Kar, Sitanshu Sekhar, and Subhranshu Sekhar Kar. “Prevention of Childhood Obesity in India: Way Forward.” Journal of Natural Science, Biology and Medicine 6, no. 1 (2015): 12. https://doi.org/10.4103/0976-9668.149071.
Ng, Marie, Tom Fleming, Margaret Robinson, Blake Thomson, Nicholas Graetz, Christopher Margono, Erin C Mullany, et al.Global, Regional, and National Prevalence of Overweight and Obesity in Children and Adults during 1980-2013: a Systematic Analysis for the Global Burden of Disease Study 2013.” Lancet (London, England) 384, no. 9945 (2014): 766–81. https://doi.org/10.1016/S0140-6736(14)60460-8.
Onis, Mercedes de, Adelheid W. Onyango, Elaine Borghi, Amani Siyam, Chizuru Nishida, and Jonathan Siekmann. “Development of a WHO Growth Reference for School-Aged Children and Adolescents.” Bulletin of the World Health Organization 85, no. 09 (September 1, 2007): 660–67. https://doi.org/10.2471/blt.07.043497.

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